Reducing Sugared Fruit Drinks in Alaska Native Children
Phase: NA
Conditions: Healthy
Sponsor: University of Washington

Reducing Sugared Fruit Drinks in Alaska Native Children 
Version 5.3 
Protocol 19-053-E 
11 October 2023 
 
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Reducing Sugared Fruit Drinks in Alaska Native Children 
Version 5.3 
Protocol 19-053-E 
11 October 2023 
 
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Reducing Sugared Fruit Drinks in Alaska Native Children 
 
NCT Number: NCT05219448 
NIDCR Protocol Number: 19-053-E 
NIDCR Grant Number: U01DE027629 
Principal Investigator: Donald L. Chi, DDS, PhD 
Grantee Institution: University of Washington 
NIDCR Program Official: Margaret Grisius, DDS 
Version Number: 5.3 
12 October 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Council for 
Harmonisation guidelines for Good Clinical Practice (GCP) (ICH E6) and the Code of 
Federal Regulations on the Protection of Human Subjects (45 CFR Part 46). National 
Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training.

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TABLE OF CONTENTS 
PAGE 
TABLE OF CONTENTS ............................................................................................................. iii 
LIST OF ABBREVIATIONS ........................................................................................................ vi 
PROTOCOL SUMMARY ........................................................................................................... vii 
SCHEMATIC OF STUDY DESIGN.................................................................................. viii 
KEY ROLES AND CONTACT INFORMATION ........................................................................... 1 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE .................. 3 
1.1 
Background Information .......................................................................................... 3 
1.1.1 
Rationale ..................................................................................................... 4 
1.2 
Potential Risks and Benefits ................................................................................... 4 
1.2.1 
Potential Risks ............................................................................................ 4 
1.2.2 
Potential Benefits ........................................................................................ 6 
OBJECTIVES AND OUTCOME MEASURES ............................................................................. 7 
2.1 Primary 7 
2.2 
Secondary .............................................................................................................. 7 
2.3 
Exploratory ............................................................................................................. 8 
STUDY DESIGN ....................................................................................................................... 10 
3.1  
Sub Studies ......................................................................................................... 11 
STUDY POPULATION .............................................................................................................. 12 
4.1  
Participant Inclusion Criteria ............................................................................. 12 
4.2 
Participant Exclusion Criteria ................................................................................ 12 
4.3 
Strategies for Recruitment and Retention ............................................................. 12 
4.4 
Treatment Assignment Procedures ....................................................................... 14 
4.4.1 
Randomization Procedures (if applicable) ................................................. 14 
4.4.2 
Masking Procedures (if applicable) ............................................................ 14 
4.5 
Participant Withdrawal or Discontinuation from Study Procedures/Intervention..... 14 
4.5.1 
Reasons for Participant Withdrawal or Discontinuation from Study 
Procedures/Intervention ............................................................................ 14 
4.5.2 
Handling of Participant Withdrawals from Study or Participant 
Discontinuation of Study Intervention ........................................................ 15 
4.6 
Premature Termination or Suspension of Study .................................................... 15 
STUDY INTERVENTION .......................................................................................................... 16 
5.1  
Study Behavioral Intervention Description ............................................................. 16 
5.2 
Administration of Intervention ................................................................................ 18 
5.3 
Procedures for Training Interventionists and Monitoring Intervention Fidelity ........ 18 
5.4 
Assessment of Participant Compliance with Study Intervention ............................ 20 
STUDY SCHEDULE ................................................................................................................. 21 
6.1 Screening .................................................................................................................. 21 
6.2 
Enrollment/Baseline .............................................................................................. 22 
6.3 
Intermediate Visits ................................................................................................ 22 
6.4 
Final Study Visit .................................................................................................... 27 
6.5 
Additional Study Visits for Control Arm ................................................................. 28 

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STUDY PROCEDURES/EVALUATIONS .................................................................................. 32 
7.1 Study Procedures/Evaluations ................................................................................ 32 
7.2 
Laboratory Procedures/Evaluations ...................................................................... 33 
7.2.1 
Clinical Laboratory Evaluations ................................................................. 33 
7.2.2 
Specimen Preparation, Handling, and Storage .......................................... 34 
7.2.3 
Specimen Shipment .................................................................................. 34 
ASSESSMENT OF SAFETY ..................................................................................................... 35 
8.1  
Specification of Safety Parameters ................................................................... 35 
8.2  
Unanticipated Problems ..................................................................................... 36 
8.3  
Adverse Events ................................................................................................... 36 
8.4  
Serious Adverse Events ..................................................................................... 37 
8.5 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 37 
8.6 
Characteristics of an Adverse Event ..................................................................... 37 
8.6.1 
Relationship to Study Intervention ............................................................. 37 
8.6.2 
Expectedness ............................................................................................ 38 
8.6.3 
Severity of Event ....................................................................................... 38 
8.7 
Reporting Procedures ........................................................................................... 38 
8.7.1 
Unanticipated Problem Reporting .............................................................. 38 
8.7.2 
Reporting of Safety Events to FDA ............................................................ 40 
8.7.3 
Reporting of Pregnancy ............................................................................. 40 
8.8 
Halting Rules ........................................................................................................ 40 
STUDY OVERSIGHT ................................................................................................................ 41 
CLINICAL SITE MONITORING ................................................................................................. 42 
STATISTICAL CONSIDERATIONS .......................................................................................... 43 
11.1  
Study Hypotheses .............................................................................................. 43 
11.1.1 Primary Hypotheses ................................................................................ 43 
11.1.2 Secondary Hypotheses ............................................................................. 43 
11.1.3 Exploratory Hypotheses ............................................................................ 43 
Sample Size Considerations ..................................................................................................... 45 
Planned Interim Analyses (if applicable) ................................................................................... 47 
13.1  
Final Analysis Plan ............................................................................................. 47 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ........................... 49 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................. 50 
ETHICS/PROTECTION OF HUMAN SUBJECTS ..................................................................... 52 
16.0  
Ethical Standard ................................................................................................... 52 
16.1 
Institutional Review Board .................................................................................... 52 
16.2 
Informed Consent Process ................................................................................... 52 
16.3 
Exclusion of Women, Minorities, and Children (Special Populations) .................... 52 
16.4 
Participant Confidentiality ..................................................................................... 53 
16.4.1 Certificate of Confidentiality ................................................................... 53 
16.4.2 NIH Data Sharing Policies ....................................................................... 53 
16.5 
Future Use of Stored Specimens and Other Identifiable Data ............................... 54 
DATA HANDLING AND RECORD KEEPING............................................................................ 55 

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17.1 
Data Capture Methods .......................................................................................... 55 
17.2 
Types of Data ....................................................................................................... 56 
17.3 
Schedule and Content of Reports ......................................................................... 56 
17.4 
Study Records Retention ...................................................................................... 56 
17.5 
Protocol Deviations ............................................................................................... 56 
PUBLICATION/DATA SHARING .............................................................................................. 57 
18.0  
NIH Public Access Policy ................................................................................... 57 
18.1  
NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information .... 57 
LITERATURE REFERENCES .................................................................................................. 58 
APPENDICES ........................................................................................................................... 61 
APPENDIX A: SCHEDULE OF EVENTS .................................................................................. 62 
APPENDIX B: DEMOGRAPHIC SURVEY (ADULT) ................................................................. 64 
APPENDIX C: DEMOGRAPHICS SURVEY (CHILD) ................................................................ 65 
APPENDIX D: STRUCTURED VISIT FORM ............................................................................. 66 
APPENDIX E: FRUIT DRINK SURVEY..................................................................................... 67 
APPENDIX F: PAPER VERSION OF FRUIT DRINK SURVEY ................................................. 71 
 
72 
APPENDIX G: FOOD SURVEY ................................................................................................ 75 
APPENDIX H: HAIR SURVEY (CAREGIVER) .......................................................................... 77 
APPENDIX I: HAIR SURVEY (CHILD) ...................................................................................... 78 
APPENDIX J: SIDE EFFECTS AND ADVERSE EVENTS FORM ............................................. 79 
APPENDIX K: Adult Consent form (intervention arm)................................................................ 81 
APPENDIX L: ADULT CONSENT FORM (CONTROL) ............................................................. 85 
APPENDIX M: ADULT CONSENT FORM (CONTROL – MODIFIED INTERVENTION) ............ 89 
APPENDIX N: ASSENT FORM (INTERVENTION) ................................................................... 93 
APPENDIX O: ASSENT FORM (CONTROL) ............................................................................ 95 
APPENDIX P: ASSENT FORM (CONTROL – MODIFIED INTERVENTION) ............................ 97 
APPENDIX Q: POST-INTERVENTION INTERVIEW GUIDE (6-month) .................................... 99 
APPENDIX R: POST ST-INTERVENTION INTERVIEW GUIDE [INTERVENTION] (12-month)
 ....................................................................................................................................... 100 
APPENDIX S: POST-INTERVENTION INTERVIEW GUIDE [CONTROL] (12-month) ............ 101 
APPENDIX T: POST-INTERVENTION INT. CATEGORIAL QUESTIONS FOR PARTICIPANT 
(12-month) ...................................................................................................................... 102 
 
103 
APPENDIX U: BEVERAGE QUESTIONNAIRE ....................................................................... 104 
 
105 
APPENDIX V: INSTRUCTIONS FOR COLLECTION OF HAIR SAMPLES ............................. 108 

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LIST OF ABBREVIATIONS 
Ace-K 
Acesulfame Potassium 
ADI 
Acceptable Daily Intake 
AE 
Adverse Event 
AIAN 
American Indian Alaska Native 
CFR 
Code of Federal Regulations 
CHW 
Community Health Worker 
DSMB 
Data and Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GEE 
Generalized Estimating Equations 
ICH 
International Council for Harmonisation 
IFC 
Intra-Family Correlation 
IOM 
Institute of Medicine 
IRB 
Institutional Review Board 
NIDCR 
National Institute of Dental and Craniofacial Research 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
PO 
Program Official 
PPE 
Personal Protective Equipment 
RCT 
Randomized Clinical Trial 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
US 
United States 
UAF 
University of Alaska Fairbanks 
UW 
University of Washington 
WHO 
World Health Organization 
YK 
Yukon-Kuskokwim 
YKHC 
Yukon-Kuskokwim Health Corporation 
 
 
 
 

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PROTOCOL SUMMARY 
Title: 
Reducing Sugared Fruit Drinks in Alaska Native Children 
 
Précis: 
Alaska Native children consume an average of 50 teaspoons 
of sugar per day and most of this added sugar is from fruit 
drinks like Tang and Kool-Aid. The goal of this community-
based behavioral trial is to reduce sugared fruit drink intake 
in Alaska Native children. In Communities A and B, a total of 
136 children ages 1-11 years will be recruited for a 6-month 
culturally-adapted, 5-session intervention consisting of video-
based health education and self-efficacy coaching delivered 
in person (or via Internet or phone in case of Covid-19 
restrictions) by an indigenous Community Health Worker. 
There will be 4 brief “check-ins” to provide social support 
(delivered via phone or through brief in-person visits outside 
the home in case of Covid-19 restrictions). Local stores have 
been recruited to carry sugar-free fruit drinks. In Community C, 
56 children will be recruited to a delayed treatment control 
group. Outcomes will be measured at baseline, 1, 3, 6, and 12 
months. 
Objectives: 
The primary child-level outcome: added sugar intake (grams of 
added sugar/day, measured via hair biomarker). The 
secondary outcome is caregiver-level added sugar intake 
(grams of added sugar/day, measured via hair biomarker). 
Exploratory outcomes include (a) caregiver knowledge, beliefs, 
and self-efficacy (measured via the fruit drink survey) and (b) 
sales of the sugar-free water enhancers (measured via sales 
reports from stores). 
The primary objective is to test the hypothesis that children in 
the intervention arm will have lower sugar intake compared to 
children in the no-treatment control arm. 
The secondary objective is to compare differences in added 
sugar intake associated with the proposed intervention in 
caregivers. 
There are four exploratory objectives: 1) to identify potential 
mechanisms associated with changes in sugared fruit drink 
and added sugar intake, 2) to assess sales of the sugar-free 
water enhancers, 3) to investigate how diet contributes to 
added sugar intake among child participants, and 4) to assess 
potential changes in mutans streptococci levels associated 
with the intervention. 

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Population: 
192 Alaska Native caregivers and their children ages 1-11 
years who live in one of three YK Delta study communities. 
Phase or Stage: 
Phase II 
Number of Sites: 
3 Alaska Native communities 
Description of 
Intervention: 
Children and their caregiver(s) in the intervention communities 
will receive a culturally-adapted, 5-session program consisting 
of video-based health education and self-efficacy coaching 
delivered by an indigenous Community Health Worker. 
Families will be introduced to sugar-free water enhancers that 
are commercially available and come in the same flavors as 
regular Tang and Kool-Aid. The sessions will include 
conversations on related topics, interactive hands-on activities, 
and homework assignments. Additionally, four brief “check-ins” 
will keep families engaged. Local stores in the intervention 
communities only will carry the sugar-free water enhancers 
that are highlighted in the health education. 
The delayed intervention for the control group will consist of 
the option to receive the home-based or remote-visits 
consisting of health education, self-efficacy coaching, and 
check-ins after the last data collection visit at 12 months. 
Study Duration: 
2 years (from enrollment to data analysis and publication) 
Subject 
Participation 
Duration: 
1 year 
Estimated Time to 
Complete 
Enrollment: 
 
 
 
 
 
 
 
 
1 month 
SCHEMATIC OF STUDY DESIGN 

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Follow-up assessment: Fruit drink survey, 24-hour food recall (child), hair 
sample (child and caregiver), plaque sample, adverse events; both arms 
Visit 5 (day 45 ± 7 days) 
Visit 6 (day 60 ± 7 days) 
Visit 7 (day 75 ± 7 days) 
Administer intervention in person (self-efficacy 3-5); intervention arm only* 
Visit 8 (day 90 + 30 days) 
Visit 9 (day 105 ± 7 days) 
Visit 10 (day 135 ± 7 days) 
Visit 11 (day 150 ± 7 days) 
Visit 12 (day 165 ± 7 days) 
Administer intervention in person (check-in 1-4); intervention arm only* 
Visit 14 (day 365 + 30 days) 
Follow-up assessment: Fruit drink survey, [discretionary] 24-hour food recall 
(child), hair sample (child and caregiver), plaque sample and beverage intake 
questionnaire; both arms. Adverse events and semi-structured interview with 
* This work will be done by 
Community Health Workers 
using (1) via phone/Internet in 
the case of Covid-19 or (2) 
using PPE and other 
preventive measures at the 
Community Clinic given 
Covid-19 restrictions. In case 
of option 1 intervention visits 
1-3 will occur via Internet and 
intervention visits 4-5 and 
check-ins 1-4 will occur by 
phone.  
Total minimum N=192: Recruit, assess eligibility, obtain consent and assent 
Baseline assessment 
Baseline demographic survey, fruit drink survey, 24-hour food recall (child), 
hair sample (child and caregiver), plaque sample; both arms 
Follow-up assessment: Fruit drink survey, [discretionary] 24-hour food recall 
(child), hair sample (child and caregiver), plaque sample; both arms. Adverse 
events with intervention families 
Final assessmentFruit drink survey, [discretionary] 24-hour food 
recall (child), hair sample (child and caregiver), plaque sample 
and beverage intake questionnaire; both arms. Adverse effects 
and exit Interviews with caregivers to identify mechanisms in 
intervention families. 
Community-Level Assignment 
Control Arm 
Community C 
(56 participants) 
Treatment Arm 
Community A and 
Community B 
Administer intervention in person (health education 1-2); intervention arm only* 
Prior to Enrollment 
Visit 1 (day 0) 
Visit 2 (day 1 + 14 days) 
Visit 3 (day 3 ± 14 days) 
Visit 4 (day 30 + 7 days) 
Visit 13 (day 180 + 30 days) 

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KEY ROLES AND CONTACT INFORMATION 
Principal 
Investigator:   
Donald L. Chi, DDS, PhD, Professor 
University of Washington (UW) 
1959 NE Pacific Street, Box 357475, Seattle, WA 98195 
Phone: 206-616-4332 
Fax: 206-685-4258 
Email: dchi@uw.edu   
NIDCR Program 
Official: 
Margaret Grisius, DDS 
NIDCR 
6701 Democracy Blvd., MSC 4878 Bethesda, MD 20892-4878 
Phone: 301-451-5096 
Email: margaret.grisius@nih.gov 
NIDCR Project 
Scientist  
 
 
 
 
 
Community 
Contacts: 
Hiroko Iida, DDS, MPH 
NIDCR 
6701 Democracy Blvd., Room 630, MSC 4878, Bethesda, MD 
20892-4878 
Phone: 301-594-7404 
Email: hiroko.iida@nih.gov 
 
Tribal Council Administrators 
Community A: Internal to study team. Not displayed to maintain 
anonymity 
Community B: Internal to study team. Not displayed to maintain 
anonymity 
Community C: Internal to study team. Not displayed to maintain 
anonymity 

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Institutions: 
University of Alaska Fairbanks (UAF) 
P.O. Box 757880, Fairbanks, AK, 99775-7000 
Subcontract PI: Diane O’Brien, PhD 
Phone: 907-474-5762 
Email: dmobrien@alaska.edu  
 
Other Key 
Personnel: 
Philip Weinstein, PhD, Co-Investigator 
Lloyd Mancl, PhD, Co-Investigator 
Todd Edwards, PhD, Co-Investigator 
Susan Coldwell, PhD, Co-Investigator 
Peter Milgrom, DDS, Co-Investigator 
Diane O’Brien, PhD, Co-Investigator 
Andrea Bersamin, PhD, Co-Investigator 
Cameron Randall, PhD, Co-Investigator 
Alice Ko, DMD, Co-Investigator 
Joshua Orack, MPH, Lead Study Coordinator 
Allison Sylvetsky, PhD, Consultant 

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INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
1.1 
Background Information 
Tooth decay is a major public health problem in American Indian and Alaska Native 
(AIAN) children (Batliner et al. 2014; Chi et al. 2015). An important risk factor for tooth 
decay is added sugar intake (Sheiham and James 2014). Added sugars are defined as 
sugars used as ingredients in prepared or processed foods and sugars eaten separately 
or added to foods. Sucrose and high fructose corn syrup are the most common added 
sugars in the U.S. (Vos et al. 2017). The American Heart Association recommends that 
children under age 2 years should avoid consuming any added sugar and children ages 
2 to 17 years should consume no more than 6 teaspoons of added sugar per day (Vos 
et al. 2017). 
Pre-R56 Pilot Research 
In Alaska’s Yukon-Kuskokwim (YK) Delta, most added sugar is from sugared fruit 
drinks, like Tang and Kool-Aid (Chi et al. 2015). Preliminary research with 54 Yup’ik 
Alaska Native children ages 6 to 17 years showed that participants consumed an 
average of 50 teaspoons of added sugar/day, 8 times the American Heart Association’s 
recommended maximum (Chi et al. 2015). Added sugar was measured using a 
validated hair biomarker (Nash et al. 2014). The data also confirmed a statistically 
significant relationship between added sugar and tooth decay, underscoring the 
potential to reduce tooth decay prevalence by addressing sugared fruit drink intake. 
Community members in the YK Delta expressed concerns about the health 
consequences of sugared fruit drinks like Tang and Kool-Aid. They noted that most 
Yup’ik caregivers: (1) do not know about the high sugar content of Tang and Kool-Aid; 
(2) would be willing to try sugar-free alternatives; and (3) need the sugar-free 
alternatives to be available locally to help support the switch away from Tang and Kool-
Aid. Community members knew that water and milk were ideal beverages but did not 
believe an intervention focusing on water or milk would be successful because most 
Yup’ik children have already developed a taste for sugared fruit drinks. All interviewed 
community members were unaware that the same companies that make Tang and 
Kool-Aid also make sugar-free versions of these drinks that come in the same flavors. 
These are called sugar-free water enhancers. They are commercially available drops 
containing sugar-free sweeteners, like sucralose and acesulfame potassium, and 
flavoring. The drops are added to drinking water to make the water taste like regular 
versions of drinks like Tang and Kool-Aid, but do not contain any sugar. Members tried 
the proposed sugar-free water enhancers, which are almost identical to the sugared 
versions. They believed the sugar-free water enhancers were easy to use, liked the 
flavors, and reported their children would like them too. 
Community members also expressed the strengths of having an indigenous member of 
the community to deliver the intervention rather than having an outsider. This person 
would know about the history of the YK Delta, have at least some working knowledge of 
Yup’ik culture, and at least understand some of the Yup’ik traditions. It would be 
important to make sure the selected interventionist is a respected member of the 

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community. An added benefit is that the job would provide some external income and 
perhaps some future career opportunities for the selected interventionists. For these 
reasons, we decided that the interventionists would be recruited from within the study 
communities and trained on how to deliver the intervention components. 
R56 Funded Research 
To confirm caregiver reports that Yup’ik children would like the sugar-free water 
enhancers, taste tests were conducted with 89 Yup’ik children ages 7 to 10 years in 
Bethel (Chi et al. 2019). There was no difference in preference for the sugared fruit 
drinks versus the sugar-free water enhancers for all 4 flavors that were evaluated 
(Tang, Kool-Aid Grape, Kool-Aid Tropical Punch, Kool-Aid Cherry). 
1.1.1 
Rationale 
There is an unresolved childhood tooth decay epidemic in indigenous communities, 
driven largely by intake of large amounts of added sugars, and a desire on the part of 
study communities to begin addressing the problem. The proposed study will begin 
addressing this epidemic by evaluating a behavioral intervention that was developed 
with critical and ongoing input from caregivers in local YK Delta communities. The 
intervention will educate caregivers about the harmful effects of sugared fruit drinks, 
empower caregivers to make healthier beverage decisions by adopting sugar-free water 
enhancers for their children, provide ongoing social support, and give families a place to 
obtain and purchase sugar-free water enhancers. 
The rationale for the study is the dearth of research on community-based behavioral 
programs focusing on improving oral health behaviors in indigenous populations. The 
work is expected to benefit the study communities and other vulnerable communities 
that face similar types of problems caused by added sugar intake.  
The main study hypothesis is that children in the intervention arm will have lower 
sugared fruit drink intake and added sugar intake compared to children in the no-
treatment control arm. 
1.2 
Potential Risks and Benefits 
1.2.1 
Potential Risks 
 
Potential risks for dignitary harm and lack of respect. To offset this concern, the study 
staff members will obtain the informed consent of participants electronically via laptops 
in a respectful, dignified manner following guidelines in place for the protection of 
human participants. In case of Covid-19 restrictions, informed consent may be 
conducted remotely by sending a REDCap link to the participant for their signature and 
conducting informed consent via phone. All oversight bodies (YKHC Human Studies 
Committee, Tribal Councils) will review cultural appropriateness of the consent process.  
 

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Potential risk for psychological distress. There is a low risk of psychological distress 
associated with participating in this study. Questions related to the child’s sugared fruit 
drink consumption may cause embarrassment, anxiety, or discomfort for some 
caregivers. Study participants will be advised of this risk during the informed consent 
process and allowed to discontinue participation in the study at any time with no 
negative repercussions, including no loss of health benefits to which they are entitled 
through the YKHC. All the hair samples collected for the study are destroyed during 
processing and there is no leftover hair for banking. There will be no testing for drugs or 
other substances on the hair specimens collected for this study. Plaque samples will be 
banked and eventually analyzed to see if the intervention affected the concentration and 
makeup of bacteria in the mouth. Plaque samples will be destroyed by the end of the 
study period in full and ongoing consultation with YKHC. 
 
Potential risk for loss of confidentiality. The communities are small, which makes it likely 
that community members will know who is participating in the study. Community Health 
Workers have completed human subjects training and will ensure that all interactions 
with families are kept confidential and that data are protected. In light of this, protocols 
will ensure that there are no identifiers on data collection documents and that all 
documents are stored securely. Paper documents will be stored in locked cases. 
Electronic data will be stored on password-protected, encrypted computers. 
 
Potential risk for psychological, social, cultural, and dignitary harm in communities. One 
potential risk is internal stigmatization (or “self-stigmatization”). For instance, if negative 
results are released to the public in a potentially stigmatizing manner, both participants 
and nonparticipating residents may self-stigmatize (i.e., consider themselves to be 
“defective” or “bad” or to have similar negative attributes). External stigmatization (i.e., 
stigmatization by outsider people against identified subgroups or the entire community), 
may also occur. We will ensure that all dissemination of findings is done respectfully, 
without blaming communities or families. Study communities will not be identified by 
name and only by letters (A, B, and C) in all publications and presentations. 
 
Potential excess intake of sugar-free sweeteners. The target sugar-free water 
enhancers are commercially available. They contain sucralose and acesulfame 
potassium (ace-K), both of which are artificial sweeteners that are well-established as 
safe, based on extensive toxicological safety data submitted to the U.S. FDA and other 
regulatory agencies worldwide (IOM 2002/2005; Magnuson et al. 2017; Magnuson et al. 
2016; Sylvetsky and Rother 2018; Sylvetsky et al. 2017). Side effects of too much 
intake of the sugar-free drinks include stomach ache and diarrhea. The side effects 
resolve without treatment when the individual stops consuming the sweetener. 
 
There are multiple strategies the study will employ to protect study participants and 
make sure they stay within the safe limits of sugar-free water enhancer intake. These 
are detailed in our Data and Safety Monitoring Plan. See Section 9.1 for safety 
parameters. 
 

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First, the health education part of the intervention emphasizes plain water and milk as 
the healthiest beverages for children, especially for children age 3 years and younger. 
 
Second, the health education will include information about potential side effects and 
the importance of limiting intake of the sugar-free drinks. Caregivers will be instructed to 
allow only adults to mix the drinks and to store the sugar-free water enhancers out of 
reach of children. 
 
Third, health education materials will recommend diluting the sugar-free water 
enhancers and following instructions on maximum numbers of servings per day that are 
provided to caregivers on a laminated card. CHWs will reinforce these instructions. 
 
Fourth, CHWs and study staff will monitor for side effects throughout the study. Local 
health aides, who are trained medical health providers employed by YKHC and live and 
work in the study communities, will be educated about the intervention and trained to 
identify side effects (see Manual of Procedures). 
1.2.2 
Potential Benefits 
There are no known benefits to study participants. If the intervention is efficacious, 
potential health benefits to the study participants include increased knowledge about the 
harmful health effects of sugared fruit drinks and reductions in added sugar intake. In 
the long-term, there could be societal benefits in the form of reduced risk of diseases 
like tooth decay, obesity, and other chronic diseases linked to sugar sweetened 
beverages. The study is expected to generate new knowledge that can be used in the 
future to improve health and well-being of Alaska Native children and other vulnerable 
communities in which sugared fruit drinks are pervasive. 

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OBJECTIVES AND OUTCOME MEASURES 
2.1 Primary 
Objective 
Brief Description/Justification 
of Outcome Measure 
Outcome Measured 
By  
Time Frame 
The primary 
objective is to 
test the 
hypothesis that 
children in the 
intervention 
arm will have 
lower added 
sugar intake 
compared to 
children in the 
no-treatment 
control arm. 
The primary child level outcome is 
added sugar intake (grams of added 
sugar/day). This outcome is the main 
target of the intervention because 
added sugar intake is a primary 
determinant of tooth decay for 
children in the study communities. 
Added sugar intake will be 
measured with a validated 
hair biomarker that will be 
obtained by trained UW 
study staff. In case of 
Covid-19 restrictions, hair 
samples may be self-
collected by participants. If 
done in person, we will 
protect participants and 
staff with PPE and other 
precautions consistent 
with local and UW policies 
(e.g., vaccination, shields). 
 
Baseline to 6 months. 
2.2 
Secondary 
Objective 
Brief Description/ 
Justification of Outcome 
Measure 
Outcome Measured By  Time Frame 
To compare 
differences in added 
sugar intake 
associated with 
proposed 
intervention in 
caregivers. 
Caregiver-level added sugar 
intake (grams of added 
sugar/day). The intervention is 
expected to decrease the 
amount of added sugars 
consumed by caregivers in the 
intervention communities. An 
alternative hypothesis is no 
difference because the 
intervention specifically targets 
child intake and not caregivers. 
Validated hair biomarker. 
Obtained by trained UW 
study staff. In case of 
Covid-19 restrictions, hair 
samples may be self-
collected by participants or 
collected in person using 
precautions.  
Baseline to 6 
months. 
 

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2.3 
Exploratory 
Objective 
Brief 
Description/Justification of 
Outcome Measure 
Outcome Measured 
By  
Time Frame 
To identify potential 
mechanisms 
associated with 
changes in sugared 
fruit drink and added 
sugar intake. 
Behavioral survey questions to 
assess changes in caregiver 
knowledge, beliefs, and self-
efficacy (see Manual of 
Procedures). The intervention is 
expected to change some of 
these behavioral factors, which 
could explain why the 
intervention works for some and 
not others.  
Fruit drink survey 
completed by caregiver 
(one for each child). 
Obtained by trained 
UW study staff. In case 
of Covid-19 restrictions, 
the fruit drink survey 
may be conducted via 
phone by UW study 
staff or collected in 
person using 
precautions. 
Baseline to 6 months. 
To investigate how 
diet contributes to 
added sugar intake 
among child 
participants.  
24 hour food recall data will be 
used to assess sugared fruit 
drink intake and to identify other 
dietary factors related to the 
primary outcome, added sugar 
intake. 
Sugared fruit drink and 
food intake will be 
measured through 24 
hour dietary recall 
interviews with 
caregivers, for each 
child at baseline and 1-
month; a validated 
dietary intake measure 
using the Nutrition Data 
System for Research 
(NDSR).  
Baseline, 1 month 
To test the 
hypothesis that 
children in the 
intervention arm will 
have lower sugar fruit 
drink consumption 
after receiving the 
intervention, 
compared to children 
in the no-treatment 
control arm. 
Beverage intake questionnaires 
will be used to assess sugared 
fruit drink intake (servings per 
day) among child participants. 
Sugared fruit drink 
intake will be measured 
using validated 
beverage intake 
questionnaires (BEVQ-
15) at 6-months and 
12-months; which will 
be administered to 
caregivers to provide 
responses, for each 
child. 
6 months and 12 
months 
 
 
 
 

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Objective 
Brief 
Description/Justification of 
Outcome Measure 
Outcome Measured 
By  
Time Frame 
To assess for 
potential changes in 
mutans streptococci 
levels associated with 
the intervention.  
 
Changes in mutans 
streptococci levels and oral 
microbiome features will be 
measured through analysis of 
oral plaque samples collected 
from children enrolled in the 
study.  
A measure of mutans 
streptococci level will 
provide a proxy for 
microbiological 
changes associated 
with changes in 
sugared fruit drink and 
added sugar intake. 
 
Baseline, 1 month, 3 
months, 6 months 
and 12 months. 
 
Samples will be 
banked and securely 
stored until there is 
funding for these 
analyses. 
 

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STUDY DESIGN 
This is a 2-arm community-based behavioral trial. Participants, interventionists, 
investigators, and outcomes data collection staff will not be masked because it is not 
feasible. Data processors will be masked. While attempts will be made to mask the 
analyst, it will likely not be effective because of the different sizes of the intervention and 
control groups. 
There is a total of 3 study communities (2 in the intervention arm and 1 in the no-
treatment control arm). The 3 communities are located in Alaska’s YK Delta, about an 
hour by airplane from Bethel. The 2 communities in the intervention arm are about 15-
minutes away from each other by airplane. The community in the control arm is about 
45 minutes away from the 2 communities in the intervention arm, which will help to 
minimize contamination between the control and the 2 treatment arms.  
Two communities will be in the intervention arm and one community in the control arm. 
Allocation to the intervention arm was based on the order in which communities were 
ready to participate in the study as assessed during recruitment of communities. 
Randomizing at the community-level would have required a sample size that is beyond 
the scope of the current study budget. Randomizing at the family- or child-levels would 
not have been possible because of the small size of study communities and high risk of 
contamination between families or among children from the same family. 
The focus is on Yup’ik Alaska Native communities because of the high rates of added 
sugar intake and tooth decay. Children are the focus of the primary outcome measure 
based on the potential for a lifetime of benefit associated with reduced added sugar 
intake. Outcomes will also be measured at the caregiver and community levels. 
Enrollment is expected to take 1 month. Study participation will last 1 year. 
There are 2 arms: an intervention arm and a control arm. 136 children in Communities A 
and B will be assigned to the intervention arm (in-person video-based health education 
led by a Community Health Worker, self-efficacy coaching, brief “check-ins”, access to 
stores that sell the target sugar-free water enhancers). In case of Covid-19 restrictions 
the health education and self-efficacy coaching may be delivered via phone or Internet 
video and the check-ins via phone, video call, or in-person outside the home. There will 
be a total of 5 visits and 4 brief “check-ins” (total face time of 2-3 hours). This visit 
frequency was determined as acceptable by community members in terms of being 
sufficient time to educate caregivers and motivate behavior change without 
overburdening families. Indigenous Community Health Workers who are from and live in 
the study communities will deliver all intervention components to maximize cultural 
saliency. 
56 children in Community C will be assigned to the delayed treatment control arm. 
Children in the control arm will have the opportunity to receive similar intervention 
components after the study ends, that incorporates learned lessons from the 

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intervention to improve content and delivery. If Covid-19 continues to result in 
restrictions at the end of the study Community C participants may also receive virtual 
visits by phone or Internet video. This will involve CHW or UW study staff-delivered 
health education, self-efficacy training, and check-ins. We will provide families with an 
equivalent number of sugar-free water enhancers distributed during the second health 
education visit for the intervention communities, based on household size. We will work 
with stores to start selling sugar-free water enhancers from the start of the control 
community intervention throughout the 6-months. We will also inform stores that there 
may be increased demand for these sugar-free water enhancers and provide them with 
ordering information. The control community intervention however, will last only 3 
months, one-half of the time over which families in Communities A and B will have 
received the intervention. We will evaluate outcomes for control families for as long as 
the budget will allow. 
The main outcome is added sugar intake in children in 3 Yup’ik communities (change 
from baseline to 6 months). The outcome will be measured at baseline, 1, 3, 6, and 12 
months. Data will be collected in person and involves collecting a hair sample from child 
participants (from which added sugar will be measured using a validated biomarker) 
(see Manual of Procedures). Hair samples will be processed at UAF. All other data will 
be managed at UW. As noted, in case of Covid-19 restrictions, hair samples may be 
self-collected by participants. See instructions for self-collection of hair samples in 
Appendix M.  
3.1  
Sub Studies 
There is 1 proposed sub-study in which plaque samples will be collected from 
participants at each data collection visit (see Manual of Procedures). Plaque specimen 
collection will be required. The plaque samples will be banked at UW and then analyzed 
in the future to assess for potential changes in mutans streptococci levels and other 
bacteria in the mouth associated with the intervention using microbiome techniques. 
The rationale is that the study lacks a disease outcome measure in this trial. The 
intervention lasts 6 months and data collection ends at 1 year, which is not long enough 
to see changes in tooth decay. A measure of intraoral bacteria levels will provide a 
proxy for microbiological changes associated with changes in sugared fruit drink and 
added sugar intake. The samples will be stored according to the specimen kit 
manufacturer instructions at the UW School of Dentistry and non-study staff will not 
have access to the samples. The samples will be labeled with a de-identified study ID. 
The consent form will include an additional line for participants to consent to plaque 
sample banking and analyses. The samples will be destroyed by the end of 2027, and 
will be done in close consultation with the YKHC. In case of Covid-19 restrictions, the 
plaque samples may not be collected, as they require in-person contact with a UW staff 
person and thus travel to the region, but in-person collection may be possible with 
added Covid-19 precautions.  

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STUDY POPULATION 
4.1  
Participant Inclusion Criteria 
To be eligible to participate in this study, an individual must meet all of the following 
criteria: 
• Child must be older than age 1 year but less than age 12 years at time of 
enrollment. Multiple children from the same family are eligible; 
• Child must live in one of the study communities; 
• Child’s parent or primary caregiver must of Yup’ik descent, be age 18 years or 
older, and willing to provide written consent to study procedures; 
• Child participant(s) ages 8 to 11 years must be willing to provide written assent to 
study procedures. Age 8 is the minimum age at which the UW IRB requires 
assent; 
• Willing to comply with all study procedures and be available for the duration of 
the study. 
4.2 
Participant Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation 
in this study: 
• Severe medical condition that would prevent them from completing the study 
procedures; 
• Allergy to sucralose or acesulfame potassium (sweeteners in the sugar-free 
water enhancers) as defined by parent report of any known allergies; 
• Sulfa drug allergy (potential hypersensitivity to acesulfame potassium) 
• Member of the same household as the Community Health Worker who will be 
delivering the intervention. 
4.3 
Strategies for Recruitment and Retention 
We will work with YKHC and may send mailings to all families in the 3 study 
communities. These mailings will be placed in their local postal boxes and will have 
information about the study, links to the study website, how to enroll, and dates of 
enrollment. We will also use contact information obtained from participants in the pre-
intervention hair study and get in touch with families who expressed an interest in 
participating in future studies. All families who participated in the pre-intervention hair 
study will also be sent findings from the hair study, which will serve the purpose of 

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disseminating findings but also to give interested families the chance to enroll for the full 
intervention through the study website.  
The enrollment goal is 192 Yup’ik children ages 1 to 11 years from the 3 study 
communities. About 410 children in the target age range who reside in the 3 study 
communities will be screened to reach the enrollment goal.  
To ensure that all eligible families are reached and that the target enrollment goal is 
met, advertisements for the study will be placed on a study website, Facebook, 
community bulletin boards, local VHF radio, washeteria boards, and word-of-mouth. 
Stores in the 2 intervention communities (A and B) have already been recruited as sites 
where caregivers will be able to obtain sugar-free water enhancers (see Manual of 
Procedures). 
The intervention was designed for younger children because they are more likely than 
older children to drink Tang and Kool-Aid and most will still have primary teeth. This is 
why children older than age 11 years are excluded at baseline. The study focuses on 
Yup’ik Alaska Native children, which is appropriate because almost everyone living the 
study communities is of Yup’ik descent. Safeguards are in place to prevent coercion by 
requiring caregiver consent from all child participants and assent from children age 8 
years and older. 
Participating caregivers will receive a $25 gift card to the local store for each data 
collection visit for each participating child. There will be a $50 bonus gift card if the 
caregiver participates in all 5 data visits (maximum total per child is $175). After the 
main study period, caregivers from the control group who agree to continue participating 
will receive a $50 gift card for each data collection visit for each participating child. 
Families in the two intervention communities will receive free samples of sugar-free 
water enhancers and vouchers that can be redeemed at the store. Vouchers will not be 
used in the control community intervention. During the data visits, children will receive a 
small gift (backpack, water bottle with study logo, study t-shirt, colorful cups, crazy 
straws). Families and children will also receive fluoride toothpaste and toothbrushes at 
each visit. In case of Covid-19 restrictions, all these items may be mailed to families 
instead of providing them in person. Additional retention strategies include maintaining 
contact with families between visits by creating a closed Facebook page, sending the 
children birthday cards, and texting and Facebook messaging families visit reminders, 
which is possible because nearly all families own a cell phone and use texting and 
Facebook as ways to communicate (see Manual of Procedures). 
To minimize loss to follow-up and missing data, attempts will be made to contact 
participants by phone before all study visits. Often times, it is possible to contact 
difficult-to-reach individuals in the YK Delta by contacting a close relative, friend, or 
neighbor – for instance, if a cell phone has become temporarily disconnected. The data 
collected at baseline will include contact information of a close relative, friend, or 
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caregiver cannot be contacted. Up to a 7-day period window will be allowed for data 
collection visit 1 and a 1-month-period for each subsequent data collection visit until an 
individual is considered to have missing data for that particular visit. An individual will be 
considered lost to follow-up if he or she fails to return for 3 consecutive data collection 
visits and is unable to be contacted by the study staff during the times at which the staff 
are in the communities for data collection.  
4.4 
Treatment Assignment Procedures 
Children in Communities A and B will be assigned to the intervention arm. Communities 
A and B are the first 2 communities that were recruited to be part of the study. Children 
in Community C will be assigned to the no-treatment control arm. Community C is the 
third community that was recruited to be part of the study. The study team made 
treatment assignment determinations as communities were recruited for the study. 
4.4.1 
Randomization Procedures (if applicable) 
Not applicable. 
4.4.2 
Masking Procedures (if applicable) 
All raw data provided to the statistician will include a participant-level variable indicating 
the community in which they live. No community names will be included in an attempt to 
mask treatment assignment. 
4.5 
Participant Withdrawal or Discontinuation from Study 
Procedures/Intervention 
All study participants are free to withdraw or discontinue from study procedures or the 
intervention. The power calculations account for 15% to 25% participant attrition, though 
the actual attrition rate is expected to be much lower based on previous studies in the 
YK Delta that have had attrition as low as 3%. 
4.5.1 
Reasons for Participant Withdrawal or Discontinuation from Study 
Procedures/Intervention 
Participants are free to withdraw from the study at any time upon request. 
Participants may choose to discontinue the intervention but will continue to be followed 
unless they choose to withdraw from the study.  
An investigator may discontinue an individual’s participation in an intervention or 
withdraw an individual from the study if: 
• Any adverse event (AE), defined as an unexpected event associated with the 
intervention, occurs such that continued participation in the study would not be in 
the best interest of the participant. 

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• The participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation. 
4.5.2 
Handling of Participant Withdrawals from Study or Participant 
Discontinuation of Study Intervention 
For participants who chose to withdraw from the study, or participants who chose to 
discontinue the study intervention, attempts will be made to collect the reason why. The 
reasons stated will be documented along with the date on which the participant 
withdrew or discontinued. Data collection will continue for participants who chose to 
discontinue the study intervention but chose not to be officially withdrawn (i.e., they 
would be willing to participate in data collection, but not the intervention). The study will 
not replace lost or withdrawn participants. 
4.6 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, 
will be provided by the suspending or terminating party to the investigator or NIDCR. 
The principal investigator will also promptly inform the IRB and NIDCR and will provide 
the reason(s) for the termination or suspension. 
Circumstances that may warrant termination include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants. 
• Insufficient adherence to protocol requirements.   
• Data that are not sufficiently complete and/or evaluable.  
• Determination of futility. 

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STUDY INTERVENTION 
5.1  
Study Behavioral Intervention Description 
 
The intervention will take place in 3 communities in the YK Delta (not named to keep 
communities anonymous). Two of the 3 study communities have been assigned to the 
intervention arm and the third community has been assigned to the control arm. 
Assignment was based on the order in which communities were recruited for the study. 
Families in the intervention arm will receive 5 home-based visits. The first 2 visits will 
consist of video-based health education delivered by an indigenous Community Health 
Worker that is expected to address knowledge gaps and to introduce families to the 
sugar-free water enhancers. The remaining 3 visits will focus on self-efficacy coaching 
to empower caregivers to make the switch to healthier beverages by working with 
caregivers to identify and help them overcome barriers to behavior change. In addition, 
there will be 4 brief “check-ins” to keep families engaged in the program. Trained 
indigenous Community Health Workers (CHW) who live in and are from the study 
communities will deliver the intervention in person. Stores in the 2 intervention 
communities have agreed to stock the sugar-free water enhancers that are highlighted 
in the health education. This intervention by CHWs will be implemented either 1) entirely 
virtually via phone/Internet in the case of Covid-19 or 2) using PPE and other preventive 
measures at the local clinic. In case of option 1 intervention visits 1-3 will occur via 
Internet and intervention visits 4-5 and check-ins 1-4 will occur by phone.  
Children in the control arm will receive no treatment initially, but families will have the 
option to receive the intervention consisting of health education, self-efficacy coaching, 
and check-ins after the last data collection visit. The same alternative approaches to the 
intervention will be put in place for the control arm if Covid-19 restrictions are still in 
place.  
Children in the intervention arm will receive a 6-month, 5-session intervention consisting 
of active video-based health education centered on sugar intake. Two visits will consist 
of health education, in which families will be shown a short whiteboard video on sugar, 
tooth decay, and sugar-free alternatives. The video will be interspersed with interactive 
activities like conversations, games, and hands-on exercises. Three visits are intended 
to help boost the self-efficacy of caregivers and provide social support. These sessions 
will focus on discussing barriers to switching to sugar-free water enhancers and ways to 
overcome these barriers. The last 4 visits will be brief “check-ins” (<5 minutes) to 
maintain contact with families, provide social support, provide vouchers for sugar-free 
water enhancers, and encourage sustained behavior change. 
All sessions will be delivered in person by an indigenous Community Health Worker 
who works and lives in the study community, unless alternative approaches are put in 
place due to Covid-19 restrictions (see above). The intervention visits are expected to 

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last a total of 2 to 3 hours spread out over 9 visits, which is sufficient to deliver key 
health education points, build rapport with families, and provide caregivers with long-
term support to facilitate behavior change – all while minimizing participant burden (see 
Manual of Procedures). 
There are 3 components to the community-based behavioral intervention: (1) health 
education; (2) access to alternatives; and (3) self-efficacy coaching and social support. 
• Health education will address knowledge gaps, reinforce susceptibility to and 
severity of tooth decay, address normative beliefs about sugared fruit drinks and 
tooth decay, and highlight the benefits and availability of sugar-free water 
enhancers. Health education will be the primary focus of the first and second 
sessions (visits 1 and 2).  
• Local access to alternatives for families will be assured through the store-
based component that is based on the Healthy Stores Program (Gittelsohn et al. 
2012). The main stores in the intervention communities have agreed to 
participate as study partners by making shelf space to sell the sugar-free water 
enhancers, to accept study vouchers, to track sales, and provide sales data to 
the study for analyses. We will incentivize stores with a start-up supply of target 
sugar-free water enhancers.  
• Self-efficacy coaching and social support. Self-efficacy coaching and social 
support will be focus of the remaining sessions (visits 3, 4, and 5) as well as the 
4 brief “check-ins”. The main activity will involve anticipating and addressing 
barriers to behavior change – with an emphasis on anticipated and unanticipated 
barriers. Following health education and the availability of sugar-free alternatives, 
many caregivers will be excited about making the switch. However, few are likely 
to anticipate barriers to change, especially on the part of the children and other 
family members. In Yup’ik culture, the child makes health and dietary decisions, 
which disempowers caregivers from reinforcing changes. Thus, self-efficacy 
coaching and social support are meant to help caregivers anticipate barriers so 
that caregivers are prepared to prevent and address barriers. Part of this will 
include homework assignments in between visits to anticipate barriers to 
switching from sugared fruit drink to the sugar-free water enhancers and to work 
with the CHW to address barriers. These homework assignments will allow 
caregivers and CHWs to discuss barriers in a non-threatening, supportive way. 
Samples and vouchers for free sugar-free water enhancers redeemable at the 
main store in the communities will further reinforce self-efficacy through 
facilitation and incentive motivation. The brief “check-ins” will help keep families 
engaged in the program and enthusiastic about behavior change. 
Children in the control arm will receive no treatment during the intervention, but will 
have the option to receive a modified intervention at the end of the study. Modifications 
will be based on feedback provided from families in the intervention arm. The control 
community intervention will last 3 months and consist of the same two health education 

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visits first, in person. Then, the control community intervention participants will have two 
self-efficacy visits and two check-in visits before the 3 month data collection study visit – 
all of which will occur remotely by phone, Zoom, and/or text. There will be two data 
collection study visits at 3 months and 6 months. Vouchers redeemable for sugar-free 
water enhancers will not be used for the control community intervention.  
5.2 
Administration of Intervention 
A trained and certified indigenous CHWs will deliver health education and self-efficacy 
coaching to intervention families (see Manual of Procedures) at the local community 
clinic (or other accessible community space), unless alternative approaches are used 
due to Covid-19 restrictions (see above). The CHWs will undergo multiple in-person and 
teleconference-based training sessions to ensure that they know how to deliver the 
standardized intervention components to study families. We will use checklists to 
evaluate CHWs as they practice with each other, study staff, and pilot families in the 
study communities. Each step will involve formal evaluation of CHWs and assessments 
of performance. There are 3 levels of certification (see Manual of Procedures) and 
CHWs will be required to meet the highest level of certification before delivering the 
intervention for the study. During the initial stages of the study, we will evaluate CHWs 
using checklists to verify that all intervention components are delivered correctly, and 
retraining will be provided as needed. After this period, the CHWs will use checklists to 
verify that intervention components were delivered. CHWs will keep careful post-visit 
field notes on a study visit template to describe each visit with families and explain if 
particular components were not delivered and why, as applicable. Study staff will review 
field notes with CHWs to help improve intervention delivery and record keeping. UW 
study staff may deliver the health education in person, the self-efficacy intervention 
visits and check-in visits if a CHW is not available in the control community. For families, 
in the delayed treatment control group, study visits and check-ins may also take place 
by phone, Zoom, or text message. 
5.3 
Procedures for Training Interventionists and Monitoring Intervention 
Fidelity 
Co-Investigators and UW study staff will train and supervise the Community Health 
Workers. Training will consist of in-person training sessions, follow-up sessions by 
telephone and FaceTime, practice delivery of the intervention with pilot families in the 
study communities, and additional training sessions by telephone, FaceTime, and in-
person if it safe to do so (see Manual of Procedures). The pilot families will be recruited 
from the communities, with the requirement being that there are no children in the home 
who would be eligible for the final intervention. 
There are 4 levels of certification: initial, intermediate, advanced, and final. To be fully 
certified, a Community Health Worker needs to achieve final certification. Community 
Health Workers will deliver health education using a video that will present basic health 
education and prompt discussions. Scripts and checklists are used to maintain fidelity 
(see Manual of Procedures). The initial certification will take place after a 2-day, in-

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person training in Bethel. The intermediate certification will take place after the 
Community Health Worker has delivered the first 3 visits to 2 families as part of the pilot 
intervention. The advanced certification will take place after follow-up trainings on 
advanced topics in person, by telephone, and by FaceTime with study staff (see Manual 
of Procedures). The final certification will occur during a 2-day in-person training in 
Bethel, about three weeks prior to study launch, when CHWs will be asked to 
demonstrate competency in delivering all components of the intervention visits. 
Following final certification, mock intervention activities, check-in’s and skills 
assessments will occur via video or phone calls with a co-investigator leading up to 
study launch (see final training log in essential documents).  
At the start of the intervention, UW study staff (led by Co-Investigators and Research 
Coordinators who were part of the CHW training) will accompany Community Health 
Workers and assess delivery of the intervention via direct observation and checklists 
and provide feedback after each session. In case of Covid-19 restrictions, this 
observation will occur via video, with a UW staff person observing the entire session 
that takes place remotely between the CHW and participating family. A CHW will be 
considered ready to deliver the intervention independently once they achieve at least 
95% on the fidelity checklist with 10 families (see Manual of Procedures). If 95% fidelity 
is not achieved, the CHW will undergo additional training with study staff and have 
opportunities to deliver the intervention under supervision. If the CHW is not able to 
achieve 95% on the fidelity checklist with 5 consecutive families after additional training, 
they will be replaced.  
As part of the ongoing intervention fidelity monitoring, each CHW will keep detailed 
post-visit field notes using a structured visit form (see Appendix C). These notes will 
include a checklist of any distractions in the home, intervention components that were 
delivered, intervention components that were modified or not delivered (along with 
reasons), follow up items (e.g., get the family a particular flavor sample), and additional 
notes that will help the CHW deliver subsequent intervention components. These field 
notes will be completed by CHWs immediately after each visit with a family on a paper 
form, then scanned and emailed to UW so they can be reviewed by UW study staff 
remotely. Field notes will be reviewed and phone meetings will be arranged with CHWs 
to discuss field note contents, challenges, and solutions. In the case of Covid-19 
restrictions, the structured visit form will be completed by the CHW in REDCap, where 
UW staff will review it. In case of Internet connectivity difficulties the CHW will fill in the 
paper form and then scan and email the form to UW. 
For the control community, UW study staff will be trained by the co-investigator who was 
in charge of training the CHWs. The goal will be for UW study staff to achieve advanced 
and final certification in order to deliver the intervention components, in lieu of a CHW if 
they are not available. Fidelity monitoring benchmarks and requirements for ongoing 
monitoring (i.e., field notes) will be consistent for UW study staff and CHWs. 

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5.4 
Assessment of Participant Compliance with Study Intervention 
CHWs will complete field notes after each study visit to record any anomalies related to 
participant compliance with the study intervention (e.g., home was too loud, caregiver 
appeared distracted, children were not present), components that were delivered as 
intended, unanticipated modifications (e.g., parts that were changed or not delivered), 
and reasons for the modifications. The structured visit form will be completed by the 
CHW immediately after each visit. The paper form will be scanned and emailed so that 
UW study staff can monitor them monthly. Phone calls with CHWs will be scheduled as 
needed to obtain more information, help problem solve, and ensure fidelity with study 
protocols. If necessary, study staff will travel to the study communities to work with 
CHWs to help solve any unanticipated problems with intervention delivery. As noted, in 
case of Covid-19 restrictions, this process will occur in REDCap and no travel to the 
study communities by UW staff will take place. If the control community intervention is 
delivered by UW study staff, the structured visit forms and field notes on paper will also 
be completed. 

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STUDY SCHEDULE 
Visit  
Time  
Window 
 
 
Purpose and Activities 
1 
 
Day 0  
Baseline 
 
 
Enroll, consent, baseline data 
2 
 
Day 1  
before 1m data 
 
Intervention visit 1: health edu 
3 
 
Day 3  
before 1m data 
 
Intervention visit 2: health edu 
4 
 
Day 30 
+7 days 
 
 
1m data collection visit 
5 
 
Day 45  
before 3m data 
 
Intervention visit 3: self-efficacy 
6 
 
Day 60 
before 3m data 
 
Intervention visit 4: self-efficacy 
7 
 
Day 75 
before 3m data 
 
Intervention visit 5: self-efficacy 
8 
 
Day 90 
±7 days 
 
 
3m data collection visit 
9 
 
Day 105 
before 6m data 
 
Intervention check-in 1 
10 
 
Day 135 
before 6m data 
 
Intervention check-in 2 
11 
 
Day 150 
before 6m data 
 
Intervention check-in 3 
12 
 
Day 165 
before 6m data 
 
Intervention check-in 4 
13 
 
Day 180 
±30 days 
 
 
6m data collection visit 
14 
 
Day 365 
±30 days 
 
 
12m data collection visit 
15 
 
Day 366 
±7 days 
 
 
Intervention visit 1: health edu* 
16 
 
Day 366 
±7 days 
 
 
Intervention visit 2: health edu* 
17 
 
Day 395 
±7 days 
 
 
Intervention visit 3: self-efficacy* 
18 
 
Day 410 
±7 days 
 
 
Intervention visit 4: self-efficacy* 
19 
 
Day 425 
±7 days 
 
 
Intervention check-in visit 1* 
20 
 
Day 440 
±7 days 
 
 
Intervention check-in visit 2* 
21 
 
Day 455 
±30 days 
 
 
3m data collection visit* 
22 
 
Day 545 
±30 days 
 
 
6m data collection visit* 
*Study visits including intervention visits occurring in the control community for participants 
interested in exercising their option to participate in the intervention. 
6.1 Screening 
Based on the lists we obtain of potentially eligible children, caregivers will be contacted 
by phone, at which point study staff will describe the study, screen for eligibility, and set 
up a time to enroll and consent if the caregiver is interested. Families will first be 
contacted about 1 month before enrollment begins.  
Screening Visit (Day -30 to -1) 

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• Confirm eligibility (child ages 1 to 11 years, Yup’ik descent, lives in the study 
community, has a caregiver age 18 years or older) and interest in participating. 
• If screening performed in person, obtain and document consent from potential 
participant on consent form. Obtain and document assent from children ages 8 to 
11 years on assent form. 
• If participant is available, collect baseline data (see next section). 
• If screening performed by phone, schedule baseline visit, during which time 
consent and assent will be obtained and baseline data will be collected. 
• In case of remote informed consent due to Covid-19 restrictions, send the person 
a link to a combined consent/assent form in REDCap and conduct informed 
consent via phone.  
6.2 
Enrollment/Baseline 
Enrollment/Baseline Visit (Visit 1, Day 0) 
• Verify inclusion/exclusion criteria. 
• Obtain and document consent from participant on study consent form. Obtain 
and document assent from children ages 8 to 11 years on assent form. If visit 
conducted remotely, obtain electronic signatures from adult and child.  
• Obtain fruit drink survey data, 24-hour food recall and food survey data for each 
enrolled child, plaque sample from child, hair sample and hair survey from each 
child participant, and hair sample and hair survey from the primary caregiver in 
the household (see Appendix for surveys and instructions for self-collection of 
hair samples). 
• If visit conducted remotely, obtain survey data via phone and enter in REDCap 
and assist participants with collection of hair samples using kit mailed to them. 
No plaque sample will be collected in case of remote study implementation.  
• Provide participants with instructions needed to prepare for Visit 2 (available at 
home for about 40 minutes, child is present, no anticipated distractions or 
interruptions). 
6.3 
Intermediate Visits 
Visit 2, Day 1 (before 1m data) 
This is the first intervention visit. 
• Answer any questions family member has about program. 

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• Administer the first video health education (about 15 minutes long) (see Manual 
of Procedures). 
• Complete exercises within the video (about 10 minutes long) (see Manual of 
Procedures). 
• Assign first homework assignment (see Manual of Procedures). 
• If visit conducted remotely, administer video education and homework via phone 
or Internet. If visit is in person, use PPE and other precautions consistent with 
community and UW safety protocols.  
• Provide participants with instructions needed to prepare for Visit 3 (available at 
home for about 30 minutes, have about a gallon of drinking water on hand, child 
is present, no anticipated distractions or interruptions). In case of remote 
delivery, send samples of sugar-free water enhancers to the participant by mail. 
• Offer exchange of sugar-free drink enhancers for sugared fruit drinks in the 
home. Family may return the sugared fruit drinks to staff after the visit, 
arrangements may need to be made to pick them up from the home, or this may 
need to occur at the next visit. 
• CHW completes structured visit form to record participant’s compliance with the 
intervention (e.g., watched the video, children were present, no distractions), 
intervention components that were delivered, intervention components that were 
modified or not delivered (along with reasons), follow up items (e.g., get the 
family a particular flavor sample), and additional notes that will help the CHW 
deliver subsequent intervention components (see Manual of Procedures). 
Visit 3, Day 3 (before 1m data) 
This is the second intervention visit. 
• Review first homework assignment. 
• Administer the second video health education (about 5 minutes long) (see 
Manual of Procedures). 
• Complete exercises within the video including mixing of sugar-free drinks (about 
20 minutes long) (see Manual of Procedures). Provide samples of sugar-free 
water enhancers. 
• If visit conducted remotely, administer video education and homework via phone 
or Internet. If visit is in person, use PPE and other precautions.  
• Assign second homework assignment (see Manual of Procedures). 
• CHW completes structured visit form (see Manual of Procedures). 

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Visit 4, Day 30 + 7 days 
This is the first data collection visit after the baseline visit (1 month). 
• Obtain fruit drink survey data, 24-hour food recall and food survey data for each 
enrolled child, plaque sample from child, hair sample and hair survey from each 
child participant, hair sample and hair survey from the primary caregiver in the 
household, and side effects/adverse events (see Appendix for surveys and 
instructions for self-collection of hair samples). 
• If visit conducted remotely, obtain survey data via phone and enter in REDCap 
and assist participants with collection of hair samples using kit mailed to them. 
No plaque sample will be collected in case of remote study implementation.  
 
Visit 5, Day 45 (before 3m data) 
This is the third intervention visit. 
• Review second homework assignment (see Manual of Procedures). 
• Plan for future resistance to behavior change and identify strategies to overcome 
barriers. 
• Assign homework to allow caregivers to document barriers and solutions (see 
Manual of Procedures). 
• Follow up with sugared fruit drink exchange (if applicable and interested). 
• Distribute vouchers for sugar-free drinks. 
• If visit conducted remotely, administer video education and homework via phone 
or Internet. If visit is in person, use PPE and other precautions.  
• Collect data on side effects/adverse events (see Appendix).CHW completes 
structured visit form (see Manual of Procedures). 
Visit 6, Day 60 (before 3m data) 
This is the fourth intervention visit. 
• Review homework on barriers and solutions to adoption of sugar-free water 
enhancers. 
• Plan for future resistance to behavior change and identify strategies to overcome 
barriers. 

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• If visit conducted remotely, administer homework and plan for overcoming 
barriers via phone. If visit is in person with Covid-19 risk, use PPE and other 
precautions.  
• Assign homework to track barriers and solutions (see Manual of Procedures). 
• Collect data on side effects/adverse events (see Appendix).  
• Distribute vouchers for sugar-free drinks. 
• Community Health Worker completes structured visit form (see Manual of 
Procedures). 
Visit 7, Day 75 (before 3m data) 
This is the fifth intervention visit. 
• Review homework on barriers and solutions to adoption of sugar-free water 
enhancers. 
• Plan for future resistance to behavior change and identify strategies to overcome 
barriers. 
• If visit conducted remotely, administer homework and plan for overcoming 
barriers via phone. If visit is in person, use PPE and other precautions. 
• Assign homework for caregivers to continue tracking barriers and solutions. 
• Collect data on side effects/adverse events (see Appendix). 
• Distribute vouchers for sugar-free drinks. 
• CHW completes structured visit form (see Manual of Procedures). 
Visit 8, Day 90 ± 7 days 
This is the second data collection visit after the baseline visit (3 months). 
• Obtain fruit drink survey data, optional 24-hour food recall and food survey data 
for each enrolled child, plaque sample from children, hair samples and hair 
survey from each child participant, hair samples and hair surveys from the 
primary caregiver in the household (or another caregiver if the primary caregiver 
is not present), and side effects/adverse events for intervention families (see 
Appendix for surveys and instructions for self-collection of hair samples). Dietary 
24 hour food recalls and food survey data may or may not be collected, for all 
participants, at the discretion of the PI.If visit conducted remotely, obtain survey 
data via phone and enter in REDCap and assist participants with collection of 
hair samples using kit mailed to them. No plaque sample will be collected in case 
of remote study implementation. 

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Visit 9, Day 105 ± 7 days 
This is the first brief check-in visit. 
• Check in on families and ask about progress (barriers and solutions), provide 
encouragement, give vouchers. 
• In case of remote implementation, call families on the phone. If in person use 
PPE and other precautions. Send samples by mail.  
• Collect data on side effects/adverse events (see Appendix). 
Visit 10, Day 135 ± 7 days 
This is the second brief check-in visit. 
• Check in on families and ask about progress, provide encouragement, give 
vouchers. 
• In case of remote implementation, call families on the phone. If in person use 
PPE and other precautions. Send vouchers by mail.  
 
• Collect data on side effects/adverse events (see Appendix). 
Visit 11, Day 150 ± 7 days 
This is the third brief check-in visit. 
• Check in on families and ask about progress, provide encouragement, give 
vouchers. 
• In case of remote implementation, call families on the phone. If in person use 
PPE and other precautions. Send vouchers by mail. 
• Collect data on side effects/adverse events (see Appendix). 
Visit 12, Day 165 ± 7 days 
This is the fourth brief check-in visit. 
• Check in on families and ask about progress, provide encouragement, give 
vouchers. 
• In case of remote implementation, call families on the phone. If in person use 
PPE and other precautions. Send vouchers by mail.  
• Collect data on side effects/adverse events (see Appendix). 
Visit 13, Day 180 + 30 days 

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This is the third data collection visit after the baseline visit (6 months). 
• Obtain fruit drink survey data, beverage intake data on the child participants 
using a validated questionnaire administered to the caregivers, plaque sample 
from children, hair samples and hair survey from each child participant, hair 
samples and hair surveys from the primary caregiver in the household (or 
another caregiver if the primary caregiver is not present), and side 
effects/adverse events for intervention families (see Appendix for surveys and 
instructions for self-collection of hair samples). Dietary 24 hour food recalls and 
food survey data may or may not be collected, for all participants, at the 
discretion of the PI.  
• Conduct semi-structured interviews with caregivers in the intervention arm about 
their family’s consumption of sugared fruit drinks, consumption and availability of 
sugar-free alternatives, and their experiences throughout the intervention.   
• If visit conducted remotely, obtain survey data via phone and enter in REDCap 
and assist participants with collection of hair samples using kit mailed to them. 
No plaque sample will be collected in case of remote study implementation.  
 
6.4 
Final Study Visit 
 
Visit 14, Day 365 + 30 days 
This is the fourth data collection visit after the baseline visit (12 months). 
• Obtain fruit drink survey data, beverage intake data on the child participants 
using a validated questionnaire administered to the caregivers, plaque sample 
from children, hair samples and hair survey from each child participant, hair 
samples and hair surveys from the primary caregiver in the household (or 
another caregiver if the primary caregiver is not present), and side 
effects/adverse events from families in the intervention arm (see Appendix for 
surveys and instructions for self-collection of hair samples). Dietary 24 hour food 
recalls and food survey data may or may not be collected, for all participants, at 
the discretion of the PI. The fruit drink surveys may be completed by participants 
using a paper version of the survey form adapted from the versions from the 
REDCap database. 
• If visit conducted remotely, obtain survey data via phone and enter in REDCap 
and assist participants with collection of hair samples using kit mailed to them. 
Conduct the post-study interview and provide final instructions by phone. No 
plaque sample will be collected in case of remote study implementation.  

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• Conduct semi-structured interviews with caregivers about their family’s 
consumption of sugared fruit drinks, consumption and availability of sugar-free 
alternatives, and their experiences throughout the intervention; along with post-
study feedback on how the program went, any perceived changes in sugared 
fruit drink behaviors, difficulties and ways to improve the program (see Appendix 
and Manual of Procedures). Some of the questions from the semi-structured 
interviews may be answered by participants using a paper based survey, prior to 
the in-person interview. 
• Provide final instructions to participant (e.g., side effects, adverse events, how to 
contact with questions) (see Manual of Procedures). 
• Obtain consent and assent for families and children in the control arm who are 
interested in participating in the second phase of the study for the modified 
control community intervention. 
6.5 
Additional Study Visits for Control Arm 
Visit 15, Day 366 ± 7 days 
This is the first control community intervention visit. 
• The components of this intervention visit will be the same as with Communities A 
and B (see visit 2 above). 
• The control community intervention may be delivered by UW Study staff, or a 
CHW, in person.  
 
Visit 16, Day 366 ± 7 days 
This is the second control community intervention visit. 
• The components of this intervention visit will be the same as with Communities A 
and B (see visit 3 above). 
• The control community intervention may be delivered by UW Study staff, or a 
CHW, in person. 
  
Visit 17, Day 395 ± 7 days 
This is the third control community intervention visit. 
• The components of this intervention visit will be the same as with Communities A 
and B (see visit 5 above). 

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• The control community intervention may be delivered by UW Study staff, or a 
CHW, in person or by Zoom, phone, or text message.  
 
Visit 18, Day 410 ± 7 days 
This is the fourth control community intervention visit. 
• The components of this intervention visit will be the same as with Communities A 
and B (see visit 5 above). 
• The control community intervention may be delivered by UW Study staff, or a 
CHW, in person or by Zoom, phone, or text message.  
 
Visit 19, Day 425 ± 7 days 
This is the first brief check-in visit. 
• Check in on families and ask about progress (barriers and solutions), provide 
encouragement. 
• In case of remote implementation by UW study staff, families will be called on the 
phone. If a CHW is available, the check-in visit may be completed in person or by 
Zoom, phone, or text message. 
 
Visit 20, Day 440 ± 7 days 
This is the second brief check-in visit. 
• Check in on families and ask about progress (barriers and solutions), provide 
encouragement. 
• In case of remote implementation by UW study staff, families will be called on the 
phone. If a CHW is available, the check-in visit may be completed in person or by 
Zoom, phone, or text message. 
 
Visit 21, Day 455 +/- 30 days 
This is the first data collection visit after the 12-month data collection from the main 
study (3m data collection visit for controls). 
• Obtain fruit drink survey data, beverage intake data on the child participants 
using a validated questionnaire administered to the caregivers, plaque sample 

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from children, hair samples and hair survey from each child participant, hair 
samples and hair surveys from the primary caregiver in the household (or 
another caregiver if the primary caregiver is not present), and side 
effects/adverse events from families in the intervention arm (see Appendix for 
surveys and instructions for self-collection of hair samples). Dietary 24 hour food 
recalls and food survey data may or may not be collected, for all participants, at 
the discretion of the PI. 
• Conduct semi-structured interviews with caregivers about their family’s 
consumption of sugared fruit drinks, consumption and availability of sugar-free 
alternatives, and their experiences throughout the intervention; along with post-
study feedback on how the program went, any perceived changes in sugared 
fruit drink behaviors, difficulties and ways to improve the program (see Appendix 
and Manual of Procedures).  
 
Visit 22, Day 545 +/- 30 days 
This is the second data collection visit after the 12-month data collection from the main 
study (6m data collection visit for controls). 
• Obtain fruit drink survey data, beverage intake data on the child participants 
using a validated questionnaire administered to the caregivers, plaque sample 
from children, hair samples and hair survey from each child participant, hair 
samples and hair surveys from the primary caregiver in the household (or 
another caregiver if the primary caregiver is not present), and side 
effects/adverse events from families in the intervention arm (see Appendix for 
surveys and instructions for self-collection of hair samples). Dietary 24 hour food 
recalls and food survey data may or may not be collected, for all participants, at 
the discretion of the PI. 
• Conduct semi-structured interviews with caregivers about their family’s 
consumption of sugared fruit drinks, consumption and availability of sugar-free 
alternatives, and their experiences throughout the intervention; along with post-
study feedback on how the program went, any perceived changes in sugared 
fruit drink behaviors, difficulties and ways to improve the program (see Appendix 
and Manual of Procedures).  
• Provide final instructions to participant (e.g., side effects, adverse events, how to 
contact with questions) (see Manual of Procedures). 
 

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STUDY PROCEDURES/EVALUATIONS 
7.1 Study Procedures/Evaluations 
Study staff and CHWs will work with store staff in the 2 intervention communities to 
make sure the sugar-free water enhancers are available throughout the study period. 
This will involve the CHW visiting the stores weekly to monitor availability, to work with 
stores to order more if needed, to check with families to make sure they are not 
experiencing any difficulties finding or buying the drinks, and to problem solve with store 
owners to address any unanticipated barriers to families finding or buying the drinks. 
For all in-person study procedures, including store visits, the CHWs will use PPE and 
other precautions. UW study staff will also work with the store in the control community 
to make sure the sugar-free water enhancers are available throughout the control 
community intervention. 
Data Collection Frequency. In all study communities, there will be 5 data collection visits 
(baseline, 1 month, 3 months, 6 months, and 12 months) which will take place 
separately from the intervention visits. In the control community, there will be 2 
additional data collection visits (3-months and 6-months) after the initial 12-month study 
period. 
Data Collection Tools. At the baseline data collection visit, demographic data, fruit drink 
survey data, 24-hour food recall and food question data will be collected for each 
participating child, a hair sample from the child(ren) and caregiver. All survey data will 
be collected electronically via laptop using a secure REDCap database, with survey 
data collection via phone in the case of remote implementation. The demographic 
survey will include standard questions found in national surveys that are validated (e.g., 
date of birth, race, household income, etc.). The fruit drink survey was developed by 
the study team and tested in the field with Yup’ik caregivers (see Manual of 
Procedures). The purpose of the fruit drink survey is to assess changes in knowledge, 
beliefs, and self-efficacy related to oral health, sugar-free drinks, and ability to help their 
children switch from sugared to sugar-free drinks. These measures will be part of the 
mediation analyses to assess for mechanisms underlying the intervention. For the 12-
month data collection visit (and control community intervention data collection visits) the 
fruit drink survey may be completed by participants using a paper version of the survey 
form adapted from the versions on the REDCap database.  
The 24-hour food recall, a validated method, will be used to measure sugared fruit 
drink intake at baseline and 1-month. There will also be a food survey to measure food 
insecurity, breastfeeding, and other relevant questions related to food intake. Additional 
24-hour food recall interviews and food surveys may or may not be conducted at 3-
months, 6-months, and 12-months.  
The Beverage Questionnaire, a validated beverage intake assessment tool (BEVQ-15) 
will be administered to caregivers to measure intake of several beverages for each of 
their enrolled children including: sugared fruit drinks, sweetened juice, 100% juice, 

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sugar-free Kool-Aid, soda pop/soft drinks, diet soda pop/articficially sweetened soft 
drinks (not including sugar-free Kool-Aid), sports drinks/energy drinks and milk. The  
The plaque sample will be collected and banked at the UW for future analyses to 
determine the effects of the intervention on bacteria in the mouth. The hair sample will 
be used to measure added sugar intake using a validated biomarker (Nash et al. 2013). 
The hair sample is accompanied by a short hair survey regarding hair condition (e.g., 
bleached, dyed, etc.). The plaque sample will not be collected in case of remote study 
implementation.  
A side effects and adverse events form will be used to record data on potential and 
other events that could come from excess intake of the sugar-free water enhancers, as 
a measure of safety, and to allow our team to intervene as needed to minimize any 
potential side effects associated with the intervention. This form will only be collected 
from intervention families. 
At subsequent data collection visits, the same information will be collected except for 
demographic data, 24-hour food recalls, and food surveys. The 6-month and final visit 
(12-month) will include semi-structured interviews with caregivers to qualitatively 
assess perceived changes in sugared fruit drink consumption, behavior changes, obtain 
feedback about the program, benefits and drawbacks, and ways to improve the 
program. Incentives will be given at each data collection visit. For the 12-month data 
collection visit (and control community intervention data collection visits), some of the 
questions from the semi-structured interviews may be answered by participants using a 
paper-based survey, prior to the in-person interview.  
7.2 
Laboratory Procedures/Evaluations 
7.2.1 
Clinical Laboratory Evaluations 
Each collected hair sample will consist of about 20 strands of hair and will be stored in a 
clear plastic Ziploc bag labeled with the participant’s study ID. Each hair sample will be 
tied together with a binder clip to indicate the section closest to the scalp that will 
undergo isotope analyses. Shorter hair samples that cannot be tied will be collected on 
in small piece of foil. One centimeter of hair corresponds to approximately 1 month of 
growth and reflects added sugar intake from the previous 1 to 2 months. Hair samples 
will be hand carried to UW after each data collection visit and samples will be batch 
mailed from Seattle to UAF for processing and analysis. In the case of remote study 
implementation due to Covid-19 all hair sampling kits will be mailed to participants 
before study start, labeled with their ID numbers. Each family will be provided with 
detailed paper instructions regarding how to obtain the sample prior to a video or phone 
call with UW study staff at baseline (see Appendix M). During the call with UW study 
staff the staff person will walk the participant through the sampling procedures while 
they are on the phone and explain how to mail the samples to UW. If CHWs are able to 
visit participants in the home using PPE and other precautions, the CHW can also 
support participants’ collection of hair. Caregivers will collect their own hair and the hair 

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from their children who are enrolled in the study. Caregivers will mail hair samples to 
UW using a pre-addressed stamped envelope. The 1cm section of the hair sample most 
proximal to the scalp will be cleaned, prepared, and analyzed for carbon and nitrogen 
isotope ratios using continuous flow isotope ratio mass spectrometry at the Alaska 
Stable Isotope Facility (Nash et al. 2014). Trained staff are employed by the facility. Hair 
samples will be solvent cleaned with sonication to remove hair care products and 
residues, and carbon and nitrogen isotope ratios will be analyzed using continuous flow 
isotope ratio mass spectrometry. Added sugar intake will be generated from carbon and 
nitrogen isotope ratios using previously estimated coefficients for the Yup’ik population 
(Nash et al. 2013).  
7.2.2 
Specimen Preparation, Handling, and Storage 
All plaque samples will be hand carried to UW from the study sites, processed and 
stored according to specimen collection kit manufacturer instructions, locked within the 
UW School of Dentistry. They will be stored until funding is obtained for future 
microbiological analyses. All hair samples will be stored at room temperature in the PI’s 
private office at UW until they are ready to be sent to UAF for processing. The plaque 
samples will be destroyed by end of 2027, or approximately 5 years after the study start. 
7.2.3 
Specimen Shipment 
Hair samples received from participants will be sent from UW to UAF via FedEx after 
each data collection visit (5 separate FedEx mailings). 

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ASSESSMENT OF SAFETY 
8.1  
Specification of Safety Parameters 
Safety concerns include potential side effects associated with excess intake of the 
artificial sweeteners in the sugar-free water enhancers (sucralose and ace-K). Side 
effects include gastrointestinal effects, stomachache, and diarrhea. Additional side 
effects may include allergic reactions, changes in insulin sensitivity, alterations in 
gastrointestinal microbiota, weight gain, and decreased satiety. Precautions will be 
taken as part of the intervention to educate caregivers on how to minimize intake of the 
target sugar-free water enhancers. All local health aides will be educated about the 
intervention and the potential for side effects in the case of excess intake and 
management protocols. 
Random samples of sugar-free water enhancers (Tang, Kool-Aid Grape, Kool-Aid 
Tropical Punch, Kool-Aid Cherry) were obtained to evaluate the concentrations of the 2 
artificial sweeteners (sucralose and ace-K). When mixed according to instructions, each 
8oz serving contains an average of 43mg of sucralose and 15 mg of ace-K (Tang 
contains no ace-K). Testing among study staff was conducted to identify the possibility 
of diluting the drinks with water to increase the maximum volume that could be 
consumed by study participants. Tables were created that the CHW will use with 
caregivers to show the maximum amount of sugar-free fruit drink children can consume 
each day (see Manual of Procedures). Pilot families in the YK Delta tried the diluted 
recipes and these were well accepted by children and caregivers. 
At each study visit, a CHW or study staff will ask the caregiver about any side effects 
experienced from the sugar-free water enhancers and will work with the caregiver to 
assess severity, source, and remedies. If the symptoms or side effects have persisted 
for more than 48 hours, the CHW will contact the Research Coordinator and Study PI to 
report the problem to a local health aide. The medical health aides are individuals who 
live in the communities and are the front-line primary medical care providers in the study 
communities. They will be asked to follow up with the family and determine the best 
course of treatment (e.g., monitor, hydration therapy, other). Between study visits, if a 
caregiver suspects that their child is experiencing side effects associated with the 
sugar-free water enhancers, they will be asked to contact the CHW. The CHW will then 
contact the Research Coordinator and Study PI. The Study PI will work with the 
caregiver and medical health aide to identify the possible cause of the side effects or 
the relationship of the adverse events to the study intervention. 
Side effects/adverse events will be classified as mild, moderate, or severe (see Manual 
of Procedures). If the side effects are mild or moderate, the child’s sugar-free water 
enhancer intake will be reduced, and the child’s side effects will be monitored over the 
next 48 hours to see if the symptoms resolve. If symptoms are severe or continue past 
48 hours, the caregiver will be asked to stop giving the child the sugar-free drinks and to 
visit the local health aide. If the child’s symptoms resolve, caregivers can elect to 
continue giving their child the sugar-free drinks under close supervision. If the same 

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symptoms or side effects return a second time, the child’s participation in the 
intervention will be terminated. The child and caregiver will be encouraged to still be 
involved in all subsequent data collection visits. 
All side effects will be recorded in the study database by the Research Coordinator. The 
following data will be recorded: participant ID, date of onset of symptoms, severity of 
symptoms, length of symptoms, any health care services sought, advice given by health 
care provider, and caregiver decision on whether to continue participating with the 
intervention. Expected adverse events will be reported to the UW IRB during annual 
continuing review. Information will be provided on how the adverse event was managed 
and resolved. The YKHC’s Chair of the HSC will be notified immediately of any adverse 
event.  We will also report all unexpected adverse events and serious adverse events to 
UW IRB within 10 business days. All serious adverse events and unanticipated 
problems will be reported to NIDCR within 10 business days. In the case of remote 
implementation of the study, side effects and adverse events will be assessed by the 
CHW during online study visits or via the phone (and entered into REDCap) and by UW 
study staff during data collection via phone.  
8.2  
Unanticipated Problems 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or 
outcome that meets all of the following criteria: 
• unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
• related or possibly related to participation in the research (“possibly related” 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and 
• suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
8.3  
Adverse Events 
An adverse event is any untoward or unfavorable medical occurrence in a human 
participant, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with participation in the 
research, whether or not considered related to participation in the research. 
 

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8.4  
Serious Adverse Events 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
• Results in death 
• Is life-threatening (places the subject at immediate risk of death from the event 
as it occurred) 
• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect   
• An important medical event that may not result in death, be life threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, the event may jeopardize the subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition. 
8.5 
Time Period and Frequency for Event Assessment and Follow-Up 
The PI will record all events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation. At each study visit, the Community Health Worker or Study Staff will 
inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for 
outcome information until resolution or stabilization.  
8.6 
Characteristics of an Adverse Event 
Each event will be recorded on an appropriate case report form that includes 
assessment of the characteristics defined below. These characteristics, along with the 
frequency of an event’s occurrence, will be considered in determining if the event is an 
unanticipated problem. 
8.6.1 
Relationship to Study Intervention 
To assess relationship of an event to study intervention the following guidelines are 
used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention, and/or 
b. There is a temporal relationship between the intervention and event onset 
and/or 
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d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event 
onset, and/or 
b. An alternate etiology has been established. 
8.6.2 
Expectedness  
The Study PI will determine whether an AE is expected or unexpected. An AE will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the intervention.   
8.6.3 
Severity of Event 
The following scale will be used to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact 
on ADL 
3. Severe: significant symptoms requiring invasive intervention; subject seeks 
medical attention, needs major assistance with ADL 
8.7 
Reporting Procedures 
8.7.1 
Unanticipated Problem Reporting  
Incidents or events that meet the OHRP criteria for unanticipated problems require the 
creation and completion of an unanticipated problem report form. OHRP recommends 
that investigators include the following information when reporting an adverse event, or 
any other incident, experience, or outcome as an unanticipated problem to the 
IRB/HSC: 
• appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
• a detailed description of the adverse event, incident, experience, or outcome;  
• an explanation of the basis for determining that the adverse event, incident, 
experience, or outcome represents an unanticipated problem;  
• a description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the unanticipated problem. 

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To satisfy the requirement for prompt reporting, unanticipated problems will be reported 
using the following timeline:   
• Unanticipated problems will be reported to the UW IRB within 10 business days 
of the investigator becoming aware of the event. The investigator will submit a 
Reportable New Information form in the UW electronic IRB submission system. 
Reporting will occur immediately to YKHC’s HSC Chair. 
• All unanticipated problems will be reported to appropriate institutional officials (as 
required by an institution’s written reporting procedures), the supporting agency 
head (or designee), and OHRP within one month of the IRB’s receipt of the 
report of the problem from the investigator. 
All unanticipated problems will be reported to NIDCR concurrently with reporting to the 
IRB. Serious Adverse Event Reporting  
Any AE meeting the specified Serious Adverse Event criteria will be submitted on an 
SAE form to NIDCR’s centralized safety system via Rho Product Safety. This report 
may be sent by fax or email. Once submitted, Rho Product Safety will send a 
confirmation email to the investigator within 1 business day. The investigator should 
contact Rho Product Safety if this confirmation is not received. This process applies to 
both initial and follow-up SAE reports. 
SAE Reporting Contact Information: 
• Product Safety Fax Line (US):  1-888-746-3293 
• Product Safety Fax Line (International):  919-287-3998 
• Product Safety Email:  rho_productsafety@rhoworld.com  
General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time):   
• US:  1-888-746-7231 
• International: 919-595-6486 
The study’s clinically responsible individual will complete a Serious Adverse Event Form 
and submit via email within the following timelines:   
• All deaths and immediately life-threatening events, whether related or unrelated, 
will be recorded on the Serious Adverse Event Form and submitted to Rho 
Product Safety within 24 hours of site awareness. 
• Serious adverse events other than death and immediately life-threatening events, 
regardless of relationship, will be reported by email or fax within 10 days of site 
awareness.   

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All SAEs will be followed until resolution or stabilization. 
In addition to being reported to NIDCR, all serious adverse events will be reported to the 
University of Washington Human Subject Division and IRB within 10 business days of 
the investigator becoming aware of the event. The investigator will submit a Reportable 
New Information form in the electronic IRB submission system at the University of 
Washington. The YKHC HSC will be notified immediately. 
8.7.2 
Reporting of Safety Events to FDA 
The artificial sweeteners (sucralose and acesulfame potassium) in the sugar-free water 
enhancers are considered food additives by the US FDA. If there are any adverse 
events observed during or after the study, the study staff will report them to the FDA by 
phone at 240-402-2405, which is the FDA Center for Food Safety and Applied Nutrition 
reporting hotline phone number. There is also the option to submit a Medwatch form at 
https://www.fda.gov/safety/report-problem-fda/how-report-non-emergency#food. We will 
report adverse events using whichever methods is available to the PI at the time of 
reporting. 
8.7.3 
Reporting of Pregnancy 
There are no specific pregnancy-related policies and procedures. 
8.8 
Halting Rules 
If there is a significant number of children who experience symptoms or side effects that 
are thought to be associated with the sugar-free water enhancers (more than 20%), an 
ad hoc safety review will be convened. The objective of the safety review is to decide 
whether the study (or intervention for an individual or study cohort) should continue per 
protocol, proceed with caution, be further investigated, be discontinued, or be modified 
and then proceed. Suspension of enrollment (for a particular group, a particular study 
site, or for the entire study) is a potential outcome of a safety review. 

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STUDY OVERSIGHT 
In addition to the PI’s responsibility for oversight, study oversight will be under the 
direction of a Data and Safety Monitoring Board (DSMB) appointed by the NIDCR. The 
DSMB will operate under the rules of an NIDCR-approved charter that will be approved 
at the organizational meeting of the DSMB. The conduct of the DSMB and rules 
regarding how often the Board will meet will be defined by the DSMB charter for the 
study. At this time, most data elements that the DSMB needs to assess will be clearly 
defined. It is anticipated that the DSMB will meet at least once per year via 
teleconference to assess safety and efficacy data, study progress, and data integrity for 
the study. If safety concerns arise, more frequent meetings may be held. The DSMB will 
operate under the rules of an NIDCR-approved charter that will be approved at the 
organizational meeting of the DSMB. At this time, most data elements that the DSMB 
needs to assess will be clearly defined. The DSMB will provide recommendations to the 
NIDCR. 
 

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CLINICAL SITE MONITORING 
Clinical site monitoring is conducted to ensure that the rights of human subjects are 
protected, that the study is implemented in accordance with the protocol and/or other 
operating procedures, and that the quality and integrity of study data and data collection 
methods are maintained. Monitoring for this study will be performed by the NIDCR’s 
Clinical Research Operations and Management Support (CROMS) contractor. The 
monitor will evaluate study processes and documentation based on the International 
Council for Harmonisation (ICH), E6: Good Clinical Practice guidelines (GCP). 
Details of clinical site monitoring will be documented in a Clinical Monitoring Plan 
(CMP). The CMP will specify the frequency of monitoring, monitoring procedures, the 
level of clinical site monitoring activities (e.g., the percentage of participant data to be 
reviewed), and the distribution of monitoring reports. Some monitoring activities may be 
performed remotely, while others will take place at the study site(s). Staff from CROMS 
will conduct monitoring activities and provide reports of the findings and associated 
action items in accordance with the details described in the CMP.  Documentation of 
monitoring activities and findings will be provided to the site study team, the study PIs, 
NIDCR-OCTOM, and NIDCR Program staff. The NIDCR reserves the right to conduct 
independent clinical site monitoring as necessary. 

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STATISTICAL CONSIDERATIONS 
11.1  Study Hypotheses 
11.1.1 Primary Hypotheses 
 
1. Children in the intervention arm will have lower added sugar intake from baseline to 
6 months compared to children in the no-treatment control arm (measured though 
hair biomarker). 
 
Null hypothesis: The average change (reduction) in added sugar intake between 
baseline and 6 months will be the same for children in the intervention arm and no-
treatment control arm. 
 
Alternative hypothesis: The average change (reduction) in added sugar intake 
between baseline and 6 months will be different for children in the intervention arm 
and no-treatment control arm. 
 
11.1.2 Secondary Hypotheses 
 
1. Caregivers in the intervention arm will have lower added sugar intake from baseline 
to 6 months compared to caregivers in the no-treatment control arm (measured 
though hair biomarker). 
 
2. Children in the intervention arm will have sustained  lower added sugar intake 6 
months after the end of the intervention as compared to children in the no-treatment 
control arm. 
 
 
 
11.1.3 Exploratory Hypotheses 
 
1. Caregivers in the intervention arm will have greater improvement in knowledge, 
beliefs, and self-efficacy related to oral health, sugar-free drinks, and ability to 
help their children switch from sugared to sugar-free drinks at the end of the 
intervention as compared to caregivers in the non-treatment control arm. 
 
 
2. Children in the intervention arm will have an altered oral microbiome, due to 
changes in sugared fruit drink and added sugar intake, as measured by mutans 

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streptococci levels and oral microbiome features through analysis of oral plaque 
samples. 
 
3. Children in the intervention arm will have lower sugared fruit drink intake after 
receiving  the intervention compared to children in the no-treatment control arm. 
 
Null hypothesis: The average  sugared fruit drink intake in ounces at  6 months 
and 12 months will be the same for children in the intervention arm and no-
treatment control arm. 
 
Alternative hypothesis: The average  sugared fruit drink intake in ounces at  6 
months and 12 months will be different for children in the intervention arm and 
no-treatment control arm. 
  
 
 
 

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SAMPLE SIZE CONSIDERATIONS 
There are about 127, 175, and 108 children ages 1 to 11 years in communities A, B, 
and C respectively. Some are siblings or relatives living in the same home. Based on a 
survey of 123 households in the 3 study communities, for the power calculations, each 
household was assumed to have an average of 2.15±1.23 children per household. In 
addition, to account for the clustering of children within households, a conservative 
intra-family correlation (IFC) of 0.3 was assumed, but an IFC as high as 0.5 was 
assumed to assess the effect on power (Eldridge et al. 2006). 
Participation in previous studies has been over 60%. Based on our pilot study, it is 
feasible and reasonable to enroll at least 50% of eligible children. Communities A and B 
will be in the intervention arm (expected N=136) and community C will be in the control 
arm (expected N=56). For the power determination, a 15% to 25% attrition rate was 
estimated by 6 months, but it is expected that actual attrition will be less than 10% by 
the 6-month follow-up. 
Power is determined for comparing the average reduction from baseline to 6 months 
between children in the intervention arm and no-treatment control arm for the  primary 
outcome: added sugar intake per day (determined by hair samples). Based on pilot data 
from 54 Yup’ik children ages 6 to 17 years, the mean±SD baseline added sugar intake, 
as measured by hair samples, is expected to be 193.0±43.6 grams per day. (Chi et al. 
2015). A correlation of 0.6 is assumed between the measures at baseline and 6 months 
to determine the standard deviation for reduction from baseline to 6 months. 
The power is calculated using a 2-sided significance level of alpha=0.025 to control the 
type I error for the testing of the  primary outcome, and using a 2-sample t-test to 
compare the average reduction between the intervention arm and no-treatment control 
arm using the expected (unequal) sample sizes and adjusted for the IFC and attrition 
(Eldridge et al. 2006). 
In the intervention arm, added sugar intake is expected to drop by 20% to 40%. Minimal 
changes are expected in the control arm, but for the power calculations have assumed 
modest reductions in the control arm. These estimates are based on a previous 
beverage substitution RCT that showed 88% reduction in the intervention group for the 
number of sugared beverages consumed per day and 3 school-based studies showing 
20% to 26% reductions in the intervention groups (Ebbeling et al. 2012; James et al. 
2004; Sichieri et al. 2014; Singh et al. 2009). 
 
The power to demonstrate a difference between the intervention arm and control arm 
for the reduction from baseline to 6 months of added sugar intake is reported in the 
Table below. Power is high (>85%) for the majority of scenarios. For example, power is 
98% to demonstrate an intervention effect for added sugar intake assuming a 30% 
reduction in the intervention arm and a 5% reduction in the control arm. 
 
Table. Power to demonstrate a difference between the intervention and control groups 
for a reduction from baseline to 6 months in added sugar intake at a 2-sided alpha = 
0.025 significance level. 

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Added sugar intake 
% Reduction 
Power 
Intervention Control IFC=0.3 (IFC=0.5) 
40% 
5% 
99% 
(99%) 
30% 
5% 
98% 
(95%) 
20% 
1% 
86% 
(76%) 
40% 
10% 
99% 
(99%) 
30% 
10% 
89% 
(81%) 
20% 
  2% 
81% 
(71%) 
 
The expected numbers of children in the intervention arm and control arm will provide 
adequate power to test secondary hypotheses about a sustained reduction in sugared 
fruit drink intake and added sugar intake 6 months after the end of the intervention for 
children in the intervention arm. Based on a 2-sided 0.05 significance level, the power is 
>80% to detect a difference of 0.60 standard deviation units in the change from baseline 
to 12 months between the two arms. For example,  power is 88% to demonstrate an 
intervention effect for a 20% reduction in the intervention arm versus a 2% reduction in 
the control arm for added sugar intake. The expected number of caregivers in the 
intervention arm is N=51 and in the control arm is N=21, and these sample sizes also 
provide adequate power to the test secondary hypothesis about a greater reduction in 
added sugar intake at the end of the intervention for caregivers in the intervention arm 
as compared to the control arm. Based on a 2-sided 0.05 significance level, the power 
is >80% to detect a difference of 0.75 standard deviation units in the change from 
baseline to 6 months between the 2 arms. For example, power is 81% to demonstrate 
an intervention effect for a 25% reduction in the intervention arm versus a 5% reduction 
in the control for the caregiver’s added sugar intake. 
 
 

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PLANNED INTERIM ANALYSES (IF APPLICABLE) 
No interim analysis is planned for stopping the study early 
13.1  Final Analysis Plan 
The analysis will be based on the intent to treat principle. Demographic variables will be 
summarized for the intervention arm and no-treatment arm at baseline and at each 
follow-up for all outcome measures and behavioral survey variables, as well as baseline 
demographics. Quantitative measures will be summarized by the mean and standard 
(or median and interquartile range for measures with a skewed distribution) and 
categorical measures will be summarized by frequency and percentage. 
Linear regression analyses will be used to test if the average change in added sugar 
intake between baseline and 6 months is the same for children in the intervention arm 
and no-treatment control arm. A 2-sided 0.025 significance level will be used for the 
tests of the  primary outcome. Generalized estimating equation (GEE) methodology will 
be used to fit the linear regression models using robust standard errors that account for 
potential clustering of outcomes within a household and allow for heteroscedasticity 
(Hardin and Hilbe 2003). Additional linear regression analyses will compare the 2 arms 
adjusted for baseline characteristics to assess for potential confounding and to assess 
for moderation of the intervention effect on child sugar intake by baseline 
characteristics, including child age, child sex, and traditional diet. In addition, to assess 
the effects of sex as a biological variable, separate estimates for the intervention effect 
on  added sugar intake will be reported by child sex. 
Similar linear regression analyses will be performed for the secondary outcomes for 
changes in caregivers’ added sugar intake, knowledge, beliefs and self-efficacy.  
Outcomes at 1 month and 3 months will be summarized to elucidate the changes from 
baseline to 6 months in the intervention arm and no-treatment arm. Linear regression 
analyses will also be used to test the exploratory hypothesis that children in the 
intervention arm will have decreased sugared fruit drink intake after having received the 
intervention (at 6 months and 12 months). 
A secondary hypothesis is that greater improvements in caregiver knowledge, beliefs, 
and self-efficacy in the intervention arm as compared to the no-treatment control will 
result in sustained reductions in sugar fruit drink intake and added sugar intake for 
children in the intervention arm 6 months after the intervention ends. This will support 
the hypothesis that behaviors are the mechanisms by which sugared fruit drink intake 
and added sugar intake are reduced. To assess this hypothesis, we will used linear 
regression analysis to test if the average chang inadded sugar intake between baseline 
and 12 months is the same for children in the intervention arm and no-treatment control 
arm. Mediation analysis will then be used to assess if changes between baseline and 6 
months in caregiver’s knowledge, beliefs, and self-efficacy mediate the change between 
baseline and 12 months in children’s sugar intake. The initial mediation analyses will 
follow the traditional approach of Baron and Kenny (1986) but the formal test for 
mediation will be based on a product of coefficients approach that directly tests for a 

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non-zero indirect effect using a bias-corrected bootstrap confidence interval (Hayes 
2013). The test for mediation will be done for each mediator individually and for all 
mediators as a group. 
Missing data will be managed as described in Strategies for Recruitment and Retention. 
Information will be collected on the reasons for discontinuation and withdrawal from the 
study. This information will be used to assess whether there is non-ignorable 
nonresponse. In the case of non-ignorable nonresponse, the method of Rotnizky et al. 
(1998) based on augmented inverse probability of censoring weighted estimating 
equations, will be used to perform a sensitivity analysis to examine how the estimated 
intervention effect on the primary outcome measures changes over a range of plausible 
values for the nonresponse mechanism. Otherwise, multiple imputation methods will be 
used to account missing outcomes and to derive intervention effect estimates consistent 
with the intent to treat principle (Schafer 2005). The goal of the study is to retain >75% 
of those enrolled. Statistical analysis will be performed using SAS Version 9.4 (SAS 
Institute Inc., Cary, North Carolina) and R version 3.5 (R Foundation for Statistical 
Computing, Vienna, Austria). 
 
To assess the hypothesis that children in the intervention arm will have an altered oral 
microbiome, due to changes in sugared fruit drink and added sugar intake, data from a 
microbiome analysis of oral plaque samples collected at five data collection timepoints 
(baseline, 1 month, 3 month, 6 month and 12 month) will be used to compare changes 
in mutans streptococci levels and other oral microbiome features (e.g., species 
abundance, composition and diversity).  Linear and log-lnear regression will be used to 
test separately if there are changes in mutans streptocci levels and other oral 
microbiome features and to compare changes in children in the intervention versus 
control communities. Robust standard errors will be used with linear regression and log-
linear regression to account for potential heteroscedasticity and overdispersion. 
 
Similar analyses will be conducted on the 3m and 6m data collected from families in the 
control community who receive the modified intervention. 
 

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SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Source data include electronically captured survey data (demographic survey data, fruit 
drink survey data, food recall data, beverage questionnaire data, hair survey data, side 
effects and adverse events data); 24-hour recall data collected electronically; post-
intervention exit interview data that will be recorded, transcribed, and coded; and paper 
field notes generated by staff and CHWs on the structured visit form. In the case of 
remote implementation, the structured visit form and side effects and adverse events 
form will be electronically captured using REDCap.  
Study staff will maintain appropriate research records for this study, in compliance with 
ICH E6, Section 4.9 and regulatory and institutional requirements for the protection of 
confidentiality of participants. All data will be stored in the Study PI’s locked private 
office within locked filing cabinets and on password-protected servers within the UW 
School of Dentistry. REDCap data will be stored on the UW REDCap server. Only study 
staff will have access to the data on a need-to-access basis. Data will be transmitted via 
secure FTP. Study staff will permit authorized representatives of NIDCR and regulatory 
agencies to examine (and when required by applicable law, to copy) research records 
for the purposes of quality assurance reviews, audits, and evaluation of the study 
safety, progress, and data validity.   

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QUALITY CONTROL AND QUALITY ASSURANCE 
The PI will ensure that all elements of the proposed work are performed, and the data 
are generated, recorded, and reported in compliance with Good Clinical Practice (GCP) 
and other applicable regulatory requirements. This will be done through training prior to 
the start of study; establishing shared mental models and goals; rigorous periodic 
review of study progress and processes; and vigilant data safety and monitoring 
processes. 
The PI will ensure quality measures are in place for all aspects of this study from 
training of staff and recruitment of participants to implementation of the protocol and 
data management. All aspects of the consenting process, including the informed 
consent form and associated documentation to confirm adherence to the consent 
process, are further discussed in the Manual of Procedures. 
UW study staff working with the PI will ensure that quality control and assurance 
protocols are operationalized in the field as planned. The team will work together to 
correct procedures that are not in compliance with the protocol.  
Quality control and assurance measures are divided into 3 categories: 1) trainings and 
fidelity monitoring to ensure proper delivery of the intervention; 2) monitoring for study 
recruitment; and 3) staff trainings and checklists to ensure accurate and complete data 
collection. 
Trainings and fidelity monitoring. Multiple trainings will be held to prepare CHWs to 
serve as study interventionists. The trainings will introduce them to the intervention and 
how each intervention piece is delivered. All trainings will be logged and the log will be 
maintained as part of the trial essential documents. The training components and 
procedures are described in detail (see Manual of Procedures). Exams will be used to 
test them on key concepts and passing grades will be necessary before a CHW can 
move onto the next stage of training. Trainees will be given opportunities to practice 
delivering the intervention with each other and with study staff using materials that will 
be used for the actual intervention (e.g., video with health educational materials loaded 
onto iPads, games, sugar demonstration props). Fidelity checklists will be used to 
assess the quality of practice intervention delivered by the CHW or UW study staff (for 
the control group intervention). There will be multiple levels of certification to ensure that 
CHWs or UW study staff can deliver the intervention with increasing sophistication. 
Once an interventionist is fully certified, they will be monitored as they deliver the 
intervention to families. The fidelity checklist will be used to assess intervention delivery 
and corrections will be made as needed via in-person feedback and re-trainings. During 
each visit, the interventionist will ensure that the participant continues to meet all 
eligibility requirements. In case of remote implementation of the study CHWs will be 
assessed via participation in video sessions to observe the quality of the intervention 
delivery.  Retraining of the CHWs will be done as needed based on the quality of the 
sessions observed by the fidelity monitor.  For the delivery of the control community 
intervention, UW study staff will be trained by a co-investigator to ensure achievement 

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of advanced and final certification in order to deliver the intervention components, in lieu 
of a CHW if they are not available. Fidelity monitoring benchmarks and requirements for 
ongoing monitoring (i.e., field notes) will be consistent for UW study staff and CHWs. 
 
Monitoring for study recruitment. Monthly reports will be generated to monitor 
enrollment. These monitoring reports will be discussed at team meetings to ensure 
adequate progress on the study goals. Advanced problem solving and solution 
generation exercises during these meetings will help prevent the group from falling 
behind on goals. 
Staff trainings and checklists. Staff trainings will be held to ensure accurate and 
complete data collection and storage (e.g., 24-hour dietary recall, hair samples, plaque 
collection). Backup plans will ensure high-quality data collection in cases where 
unanticipated problems arise. Participant-level checklists will be used to ensure that all 
necessary data elements are collected at each data collection visits. All data documents 
will be reviewed for completeness within 24 hours so that relevant corrections or 
unintentionally missing data can be identified and possibly collected, and to identify 
necessary AE/SAE reporting. Data accuracy will be confirmed at level of data entry by 
the Lead Study Coordinator. Staff training methods will include hands on training, 
practice sessions, validation exercises to ensure accuracy, and certification. 

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ETHICS/PROTECTION OF HUMAN SUBJECTS 
16.0  Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6. 
16.1 
Institutional Review Board 
The protocol, informed consent form, assent form, recruitment materials, and all 
participant materials will be submitted to the UW IRB for review and approval. Approval 
of these materials must be obtained before any participant is enrolled.  Any amendment 
to the protocol will require review and approval by the IRB before the changes are 
implemented in the study. 
16.2 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Extensive 
discussion of risks and possible benefits of study participation will be provided to 
participants and their families. The consent form describing in detail the study 
procedures and risks will be given to the participant (see Manual of Operations). 
Consent forms will be IRB-approved, and the participant is required to read and review 
the document or have the document read to him or her. A Research Coordinator will 
explain the research study to the participant and answer any questions. The participant 
will sign the electronic informed consent document prior to any study-related 
assessments or procedures. Participants will be given the opportunity to discuss the 
study with their surrogates or think about it prior to agreeing to participate. They may 
withdraw consent at any time throughout the course of the study. An electronic copy of 
the signed informed consent document will be emailed or printed on site to give to 
participants for their records. The rights and welfare of the participants will be protected 
by emphasizing to them that the quality of their clinical care will not be adversely 
affected if they decline to participate in this study. In the case of remote implementation 
of the study, the REDCap electronic consent form will be emailed to the adult participant 
using a personalized REDCap link. A trained UW staff member will then discuss the 
form with the adult on the phone and, if the caregiver agrees, he/she will sign the form 
electronically. In case of Internet connectivity problems a paper consent form will be 
mailed to the adult and consent will be explained by phone with the signed paper 
consent form returned to the UW in a pre-addressed envelope. 
16.3 
Exclusion of Women, Minorities, and Children (Special Populations) 
The study will exclude children younger than age 1 year and older than age 11 years at 
baseline from the study. The reason is that the intervention focuses on reducing Tang 

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and Kool-Aid intake which is more common among younger children compared to older 
children. We exclude children younger than age 1 year to eliminate any potential safety 
concerns associated with sugar-free water enhancer intake. The study also focuses on 
Alaska Native children and therefore will exclude non-Alaska Native children. 
16.4 
Participant Confidentiality 
Participant confidentiality is strictly held in trust by the investigators, study staff, and the 
study sponsor and their agents. This confidentiality is extended to cover testing of 
biological samples in addition to any study information relating to participants. 
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the study 
sponsor. 
The study monitor or other authorized representatives of NIDCR may inspect all study 
documents and records required to be maintained by the investigator for the study 
participants. 
16.4.1 Certificate of Confidentiality 
To further protect the privacy of study participants, the Secretary, Health and Human 
Services (HHS), has issued a Certificate of Confidentiality (CoC) to all researchers 
engaged in biomedical, behavioral, clinical, or other human subjects research funded 
wholly or in part by the federal government. Recipients of NIH funding for human 
subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (https://humansubjects.nih.gov/coc/index). As 
set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-
supported research covered by this Policy are required to establish and maintain 
effective internal controls (e.g., policies and procedures) that provide reasonable 
assurance that the award is managed in compliance with Federal statutes, regulations, 
and the terms and conditions of award. It is the NIH policy that investigators and others 
who have access to research records will not disclose identifying information except 
when the participant consents or in certain instances when federal, state, or local law or 
regulation requires disclosure. NIH expects investigators to inform research participants 
of the protections and the limits to protections provided by a Certificate issued by this 
Policy. 
16.4.2 NIH Data Sharing Policies  
As described in section 17, it is NIH policy that the results and accomplishments of the 
activities that it funds should be made available to the public (see 
https://grants.nih.gov/policy/sharing.htm). PIs and funding recipient institutions will 
ensure that all mechanisms used to share data include proper plans and safeguards to 
protect the rights and privacy of individuals who participate in NIH-sponsored research.  

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16.5 
Future Use of Stored Specimens and Other Identifiable Data 
As part of the consent process, additional permission will be obtained to conduct 
analyses of the banked plaque sample, but only to answer specific questions related to 
how the intervention worked and for whom the intervention was responsive through 
mutans streptococci enumeration and the oral microbiome composition. We will not use 
the biospecimens for any commercial purpose. We will make no attempt to identify 
participants or contact participants to which the plaque specimens pertain. We will make 
no disclosure of the plaque biospecimen to third parties without written consent of 
YKHC. We will make no secondary research uses of the plaque biospecimens other 
than the uses identified in the protocol. Plaque biospecimens will not be used in clinical 
trials or for diagnostic purposes involving humans. Plaque biospecimens are to be used 
only in the UW’s research facilities or with collaborators working under the direct 
supervision of the study PI. The plaque samples will be destroyed by end of 2027, 
approximately 5 years after study start. Policies and procedures for community, ethical, 
and scientific review and approval will always apply. This policy is a core part of both 
the strong community-researcher consensus and agreement, and also of the team’s 
respect for the Alaska Native people, communities, and entire regions. In case of 
remote implementation of the study, plaque sampling will not occur.  

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DATA HANDLING AND RECORD KEEPING 
The investigators are responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents will be completed in a neat, 
legible manner to ensure accurate interpretation of data. The investigators will maintain 
adequate case histories of study participants and source documentation. 
17.0  Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the investigator. All source documents and laboratory reports 
will be reviewed by the study team, who will ensure that they are accurate and 
complete. Side effects and adverse events will be reviewed by the PI.   
17.1 
Data Capture Methods 
There are multiple data capture methods: paper, electronic, biological, and digitally 
recorded. All paper data will be entered into the study REDCap database.  
Paper field notes, if applicable, will be hand carried from field research sites to the UW, 
at which point they will be scanned and saved onto secure, password-protected servers. 
The original notes will be stored in locked filing cabinets in the Study PI’s secure office 
at the UW. Paper field notes maintained by Community Health Workers may be 
scanned and emailed from the local health clinics to UW using YKHC scanners or 
collected by UW study staff and hand carried from the field research sites to the UW. All 
original paper documents will be maintained by the CHW in lockable cases that can be 
moved from place to place. As soon as CHWs have scanned and emailed original 
documents to UW the original documents will be stored in the lockable cases. In case of 
remote delivery of the intervention, paper study forms will only be used in case of 
Internet outages.  
All survey data (demographic, fruit drink, food, hair, beverage questionnaire, adverse 
events) will be captured electronically on a laptop that has a secure REDCap database 
installed or will be entered onto REDCap by UW study staff while the participant 
answers questions over the phone. The laptop will be password protected and will only 
be used by study staff. The laptop will remain with staff while in the field and will be 
transported to UW at the end of visits to the communities. Data will be uploaded onto 
secure servers at UW when Wi-Fi access is available. Alternately all data collection may 
be conducted remotely due to Covid-19 restrictions.  
The 24-hour food recall data will be collected electronically by a study staff member in 
person or via phone/video call using the University of Minnesota’s Nutrition Data 
System for Research (NDSR) on password-protected study laptops. NDSR files will be 
shared with study personnel using secure, password-protected servers. Study staff will 
have ways to back up NDSR data and will carry paper data collection forms in case of 
laptop failures. In case of remote study delivery there will be no need for paper forms.  

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Plaque samples will be identified by study ID only and will be hand carried to UW by 
trained study staff and stored according to manufacturer instructions. Hair samples will 
be identified by study ID only and will be hand carried to UW by trained study staff and 
then mailed to UAF for processing and biomarker analysis. The hair is destroyed during 
the processing and biomarker data will be stored on secure, password-protected 
servers. Data will be transferred from UAF to UW via secure FTP. As noted, in case of 
remote delivery of the study plaque samples will not be collected and hair samples will 
be self-collected by study participants.  
All qualitative data (e.g., 6-month and 12-month post-intervention interview with 
caregivers) will be audio recorded. Recordings will be protected from disclosure by 
uploading digital files onto password-protected study laptops. These files will be 
transmitted electronically to secure servers at the UW and stored on secure, password-
protected servers. All transcribed data will be stored on secure, password-protected 
servers at the UW, which only members of the study team having a role in data analysis 
will have access to. 
17.2 
Types of Data 
There are multiple types of data that will be collected including demographic, 
behavioral, biomarker, food, diet, weight, safety, and interview data. 
17.3 
Schedule and Content of Reports 
Weekly reports will be generated to monitor enrollment and monthly reports to 
summarize study progress (enrollment, intervention visits completed, data collection 
points completed). The final data analysis will be completed within 3 months of having 
all the necessary study variables. The statistician will be masked on whether the 
community is in the intervention vs. comparison group. 
17.4 
Study Records Retention 
Study records will be maintained for at least 3 years from the date that the last grant 
federal financial report is submitted to the NIH. 
17.5 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol or Good 
Clinical Practice requirements. The noncompliance may be on the part of the 
participant, the investigator, or study staff. As a result of deviations, corrective actions 
are to be developed by the study staff and implemented promptly. 
These practices are consistent with investigator and sponsor obligations in ICH E6. 
All deviations from the protocol must be addressed in study participant source 
documents and will be reported to the IRB and NIDCR, according to their requirements, 
at the agreed upon timeframe. 

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PUBLICATION/DATA SHARING  
Before disseminating our study findings to the scientific community at research 
conferences and peer-reviewed journals, all study findings will be reviewed by the 
Yukon-Kuskokwim Health Corporation’s Human Studies Committee. Any publications, 
abstract, or presentations involving data from this study must be approved in writing by 
the YKHC. The YKHC requires at least 60 days advanced notice to review reports, 
manuscripts, and conference abstracts. Research results will be submitted to the YKHC 
Board for review before we make them public in professional journals, other news 
media, or presentations. When research results are reported in a professional setting, 
such as in a peer-reviewed journal or at a scientific meeting, the identity of individual 
research participants and their communities will not be disclosed. We agree to provide 
appropriate acknowledgement of YKHC as the source of the data in all appropriate 
published or oral communications involving the research project. This is a mandatory 
step prior to any public dissemination of research findings related to local Yup’ik 
populations. Next, study findings will be shared with local communities, including Tribal 
Council and local community meetings. 
This study will comply with all applicable NIH Data Sharing Policies. See 
https://grants.nih.gov/policy/sharing.htm for policies and resources. 
18.0  NIH Public Access Policy 
The NIH Public Access Policy requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to PubMed Central immediately upon acceptance 
for publication. This ensures that the public has access to the published results of NIH 
funded research.  
18.1  NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information 
The study is a clinical trial and will comply with the NIH policy that establishes the 
expectation that all investigators conducting clinical trials funded in whole or in part by 
the NIH will ensure that these trials are registered at ClinicalTrials.gov, and that results 
of these trials are submitted to ClinicalTrials.gov.   

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LITERATURE REFERENCES 
Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 
2001;52:1-26. 
 
Baron RM, Kenny DA. The moderator-mediator variable distinction in social 
psychological research: conceptual, strategic, and statistical considerations. J Pers Soc 
Psychol T. 1986;51(6):1173-82. 
 
Batliner T, Wilson AR, Tiwari T, Glueck D, Henderson W, Thomas J, Braun P, Cudeii D, 
Quissell D, Albino J. Oral health status in Navajo Nation Head Start children. J Public 
Health Dent. 2014;74(4):317-25. 
 
Chi DL, Coldwell SE, Mancl L, Hopkins S, Senturia K, Randall CL, Orr E, Cruz S. 
Alaska Native Children Do Not Prefer Sugar-Sweetened Fruit Drinks to Sugar-Free Fruit 
Drinks. J Acad Nutr Diet. 2019;119(6):984-990. 
 
Chi DL, Hopkins S, O’Brien D, Mancl L, Orr E, Lenaker D. Association between added 
sugar intake and dental caries in Yup’ik children using a novel hair biomarker. BMC Oral 
Health. 2015;15(1):121. 
 
Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, 
Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body 
weight. N Eng J Med. 2012;367:1407-1416. 
 
Eldridge SM, Ashby D, Kerry S. Sample size for cluster randomized trials: effect of 
coefficient of variation of cluster size and analysis method. Int J Epidemiol. 
2006:35;1292-1300. 
 
Fitch C, Keim KS; Academy of Nutrition and Dietetics. Position of the Academy of 
Nutrition and Dietetics: use of nutritive and nonnutritive sweeteners. J Acad Nutr Diet. 
2013;112(5):739-58. 
 
Gittelsohn J, Rowan M, Gadhoke P. Interventions in small food stores to change the 
food environment, improve diet, and reduce risk of chronic disease. Prev Chronic Dis. 
2012;9:E59. 
 
Hardin JW, Hilbe JM. Generalized Estimating Equations. New York: Chapman & 
Hall/CRC, 2003. 
 
Hayes AF. Introduction to Mediation, Moderation, and Conditional Process Analysis: A 
Regression-Based Approach. 2013, New York: Guilford. 
 
Institute of Medicine (IOM). 2002/2005. Dietary reference intakes for energy, 
carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids / Panel on 

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Macronutrients, Panel on the Definition of Dietary Fiber, Subcommittee on Upper 
Reference Levels of Nutrients, Subcommittee on Interpretation and Uses of Dietary 
Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary 
Reference Intakes, Food and Nutrition Board. Washington, DC: IOM. 
 
James J, Thomas P, Cavan D, Kerr D. Preventing childhood obesity by reducing 
consumption of carbonated drinks: clustered 59andomized controlled trial. Br Med J. 
2004;328:1237-1239. 
 
Magnuson BA, Carakostas MC, Moore NH, Poulos SP, Renwick AG. Biological fate of 
low-calorie sweeteners. Nutr Rev. 2016;74(11):670-689. 
 
Magnuson BA, Roberts A, Nestmann ER. Critical review of the current literature on the 
safety of sucralose. Food Chem Toxicol. 2017;106(Pt A):324-355. 
 
Nash SH, Kristal AR, Hopkins SE, Boyer BB, O’Brien DM. Stable isotope models of 
sugar intake using hair, red blood cells, and plasma, but not fasting plasma glucose, 
predict sugar intake in a Yup’ik study population. J Nutr. 2014;144(1):75-80. 
 
Nash SH, Kristal AR, Bersamin A, Hopkins SE, Boyer BB, O’Brien DM. Carbon and 
nitrogen stable isotope ratios predict intake of sweeteners in a Yup’ik study population. 
J Nutr. 2013;143(2):161-5. 
 
Rotnizky A, Robins JM, Scharfstein DO. Semiparametric regression for repeated 
outcomes with nonignorable nonresponse. J Am Stat Assoc. 1998;93:1321-1339. 
 
Schafer JL. Analysis of Incomplete Multivariate Data. New York, NY: Springer-Verlag; 
2005. 
 
Sheiham A, James WP. A new understanding of the relationship between sugars, 
dental caries and fluoride use: implications for limits on sugars consumption. Public 
Health Nutr. 2014;17(10):2176-84. 
 
Sichieri R, Trotte AP, de Souza RA, Veiga GV. School 59andomized trial on prevention 
of excessive weight gain by discouraging students from drinking sodas. Public Health 
Nutr. 2008;12:197-202. 
 
Singh AS, Paw M, Brug J, van Mechelen W. Dutch obesity intervention in teenagers 
effectiveness of a school-based program on body composition and behavior. Arch 
Pediatr Adolesc Med. 2009;163:309-317. 
 
Sylvetsky AC, Jin Y, Clark EJ, Welsh JA, Rother KI, Talegawkar SA. Consumption of 
Low-Calorie Sweeteners among Children and Adults in the United States. J Acad Nutr 
Diet. 2017;117(3):441-448.e2. 
 

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Sylvetsky AC, Rother KI. Nonnutritive Sweeteners in Weight Management and Chronic 
Disease: A Review. Obesity (Silver Spring). 2018;26(4):635-640. 
 
Vos MB, Kaar JL, Welsh JA, Van Horn LV, Feig DI, Anderson CAM, Patel MJ, Cruz 
Munos J, Krebs NF, Xanthakos SA, Johnson RK; American Heart Association Nutrition 
Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Clinical 
Cardiology; Council on Cardiovascular Disease in the Young; Council on 
Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council 
on Functional Genomics and Translational Biology; and Council on Hypertension. 
Added Sugars and Cardiovascular Disease Risk in Children: A Scientific Statement 
From the American Heart Association. Circulation. 2017 May 9;135(19):e1017-e1034. 

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APPENDICES 

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APPENDIX A: SCHEDULE OF EVENTS 
Procedures 
Screening (Day –
30 to –1) 
Baseline Visit 1 
(Day 0) 
Study Visit 2 
(before 1m data) 
Study Visit 3 
(before 1m data) 
Study Visit 4 (Day 
30 + 7 days) 
Study Visit 5 
(before 3m data) 
Study Visit 6 
(before 3m data) 
Study Visit 7 
(before 3m data) 
Study Visit 8 (Day 
90 ± 7 days) 
Study Visit 9 
(before 6m data) 
Study Visit 10 
(before 6m data) 
Study Visit 11 
(before 6m data) 
Study Visit 12 
(before 6 months 
Study Visit 13 
(Day180±30days) 
Study Visit 14 
(Day 360±30days) 
Signed Consent and Assent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X** 
Assessment of Eligibility 
Criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X** 
Study Intervention 
 
 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
 
 
Other Procedures:  
Demographic data 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Procedures:  
Fruit drink survey  
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
X 
X 
Other Procedures:  
24-hour food recall data*, 
food survey*, hair survey, 
beverage questionnaire 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
X 
X 
Plaque sample from child 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
X 
X 
Hair sample from child and 
caregiver (about 20 strands) 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
X 
X 
Side effects and adverse 
events 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Other Procedures:  
Qualitative intervention 
feedback interview 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
*Optional at Study Visit 8 (3m), Study Visit 13 (6m), and Study Completion (12m) 
** For interested families in the control group only 

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Procedures 
Control Study Visit 
15 (before 3m 
data) 
Control Study Visit 
16 (before 3m 
data) 
Control Study Visit 
17 (before 3m 
data) 
Control Study Visit 
18 (before 3m 
data) 
Control Study Visit 
19 (before 3m 
data) 
Control Study Visit 
20 (before 3m 
data) 
Control Study Visit 
21 3m data 
collection visit 
Control Study Visit 
22 6m data 
collection visit  
Signed Consent and Assent 
X 
 
 
 
 
 
 
 
Assessment of Eligibility 
Criteria 
X 
 
 
 
 
 
 
 
Study Intervention 
X 
X 
X 
X 
X 
X 
 
 
Other Procedures:  
Demographic data 
 
 
 
 
 
 
X 
X 
Other Procedures:  
Fruit drink survey  
 
 
 
 
 
 
X 
X 
Other Procedures:  
24-hour food recall data*, 
food survey*, hair survey 
 
 
 
 
 
 
X 
X 
Plaque sample from child 
 
 
 
 
 
 
X 
X 
Hair sample from child and 
caregiver (about 20 
strands) 
 
 
 
 
 
 
X 
X 
Side effects and adverse 
events 
 
 
 
 
 
 
X 
X 
Other Procedures:  
Qualitative intervention 
feedback interview 
 
 
 
 
 
 
X 
X 
 
*Optional at Study Visit 14 
 

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APPENDIX B: DEMOGRAPHIC SURVEY (ADULT) 
 
 
 

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APPENDIX C: DEMOGRAPHICS SURVEY (CHILD) 
 

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APPENDIX D: STRUCTURED VISIT FORM 
 

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APPENDIX E: FRUIT DRINK SURVEY 
 
 
 

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APPENDIX F: PAPER VERSION OF FRUIT DRINK SURVEY 
 

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APPENDIX G: FOOD SURVEY 
 
 
 
 
 
 
 

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APPENDIX H: HAIR SURVEY (CAREGIVER) 
 
 

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APPENDIX I: HAIR SURVEY (CHILD) 
 

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APPENDIX J: SIDE EFFECTS AND ADVERSE EVENTS FORM 
 
 
 
 

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APPENDIX K: ADULT CONSENT FORM (INTERVENTION ARM) 
 
Study Participation Consent & Parental Permission Form: Intervention Arm  
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Main Researchers: Dr. Donald Chi, Professor, University of Washington, School of Dentistry, 
Department of Oral Health Sciences, 206-616-4332  
  
Researchers’ Statement  
We are asking you and your child to be in a research study.  The purpose of this consent form is 
to give you the information you’ll need to help you decide if you want to be in the study or 
not.  Please read the form carefully.  You may ask any questions about the research or this 
form.  When we have answered all your questions, you can decide if you want to be in the study 
or not.  This process is called “informed consent.”  We will give you a copy of this form for your 
records.  
  
PURPOSE OF THE STUDY  
The study goal is to learn if a community program can help Yup’ik children to drink less sugary 
drinks and have fewer cavities. In the study, participants will be assigned into either an 
intervention community (receive the program first) or a control community (receive the program 
later). Your community has been assigned to the intervention community. That means you will 
receive the program first.  
  
STUDY PROCEDURES  
The study will last about one year. We will ask you and your child to join us at the Community 
Clinic 5 times. A trained staff person will ask you questions about your children’s diet, measure 
your child’s weight, use scissors to cut about 20 strands of hair from yourself and your child and 
collect an oral plaque specimen using a swab. Each visit will last up to 1 and 1/2 hours. You will 
receive a $25 store gift card per child after completing each visit. If you and your child make all 
5 visits, you will receive a $50 bonus gift card for each child after the last visit. At the 4th and 5th 
visit, we will ask for your feedback about the health program. We would like to audio record the 
conversations if that is okay with you. You can review transcripts of the conversations if you 
would like.    
  
In addition, a trained Community Health Worker (CHW) will contact you and your child 9 times 
during the 6-month study period.  Each visit will last 5 to 30 minutes, for about 2-3 hours total. 
In the first visit, we will show information about fruit drinks and cavities. In the second visit, we 
will introduce sugar-free drinks by sending you supplies in the mail. During the third to fifth 
visits, we will work with you to improve ways to get your child to accept healthier drinks. After 
that, there will be four 5-minute check-ins to see your progress in the program. In case there is a 
COVID-19 risk at the time of these visits, the CHW will either conduct the visits entirely by 
Internet using a tablet or will visit your home using a mask and other precautions such as social 
distancing.  
  
RISKS, STRESS, OR DISCOMFORT  

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You may feel uncomfortable participating in our study in some situations. First, in some cases, 
when children have too many sugar-free fruit drinks, they might have an upset tummy or runny 
stool. These side effects may also occur in adults. Sugar-free fruit drinks are FDA-approved and 
safe for children when they drink the right amount. To be safe, families who participate in our 
program should follow the mixing instructions. Caregivers need to keep an eye on the number of 
sugar-free drinks they and their child have.   
  
Second, there is a chance that other community members may be aware of your participation in 
our study. That may make you feel uncomfortable. However, your personal information will be 
securely stored. We will not share your information with anyone besides our study staff.   
  
Third, you and your children may feel uncomfortable about providing your weight, hair and oral 
plaque samples. You may also feel uncomfortable sharing what your children ate. If you or your 
children feel any discomfort, you may stop participating at any time. Your decision will not 
change the care that you and your child receive from YKHC. You and your child may say no to 
any part of the study. You and your child are free to drop off from this study at any time without 
penalty or loss of your current benefits.  
  
 BENEFITS OF THE STUDY  
Direct benefits include receiving oral health information and counseling. You will also receive 
free sugar-free drink samples. You and your child may or may not experience a direct health 
benefit. However, by switching sugared-fruit drinks to sugar-free fruit drinks, we expect your 
child to have less sugar intake and cavities.   
  
SOURCE OF FUNDING  
The study is funded by the National Institutes of Health.  
  
CONFIDENTIALITY OF RESEARCH INFORMATION  
Information about this study will be available on http://www.clinicaltrials.gov, as required by 
U.S. Law. This website will not include information that can identify you. You can search this 
Web site at any time.  
  
You and your children’s information are confidential. The samples and information you and your 
child provide will be stored with only an identification number. Your and your child’s name will 
not appear on the samples and information. Only de-identified information and samples will be 
provided to the researcher doing the analysis. Your name on the consent form will be kept 
separate from the information you provide for the study. Identifying information will be stored in 
locked file cabinets at the University of Washington.   
  
We submit research findings to the YKHC Board for review and approval before we make them 
public in professional journals, other news media, or presentations. When research findings are 
reported in a professional setting, such as in a medical journal or at a scientific meeting, we will 
not identify you and your community.   
  

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We have a Certificate of Confidentiality from the federal National Institutes of Health. This 
helps us protect your privacy. The Certificate means that we do not have to give out identifying 
information about you even if we are asked to by a court of law. We will use the Certificate to 
resist any requests for identifying information.   
  
We can’t use the Certificate to withhold your research information if you give your written 
consent to give it to an insurer, employer, or other person. Also, you or a member of your family 
can share information about yourself or your part in this research if you wish.  
  
There are some limits to this protection. We will voluntarily provide the information to:  
• 
a member of the federal government who needs it in order to audit or evaluate the 
research;  
• 
individuals at the University of Washington, the funding agency, and other groups 
involved in the research, if they need the information to make sure the research is being done 
correctly;  
• 
the FDA, if required by the FDA;  
• 
state or local authorities, if we learn of child abuse, elder abuse, or the intent to harm 
yourself or others.  
  
The Certificate expires when the NIH funding for this study ends.  Currently this is March 31, 
2023.  Any data collected after expiration is not protected, as described above.  Data collected 
prior to expiration will continue to be protected.    
  
Government or university staff sometimes review studies to make sure they are being done safely 
and legally.  If a review of this study takes place, your records may be examined.  The reviewers 
will protect your privacy.  The study records will not be used to put you at legal risk of harm.  
  
  
  
USE OF INFORMATION AND SPECIMENS  
The information you provide in this study may be used for future research studies related to oral 
health. It is also possible that in the future we may want to use or share study information that 
might identify you. If we do, we will obtain additional consent from you at that time.   
You and your child’s hair and oral plaque samples belong to you. These samples will be stored at 
UW and UAF. All the samples are stored with only an identification number. Your and your 
child’s name will not appear on your samples. Analyses of your hair samples will be conducted 
under the direction of Dr. Diane O'Brien, our collaborator on this project. Plaque samples will be 
stored at UW in a secure freezer for analysis at a later date. This research does not involve giving 
treatment or other medical care as a part of the study. It only involves using this information to 
better understand sugar intake and cavities among Alaska Native children. You and your child's 
hair samples will be destroyed after analysis; there will not be any remaining unused sample. The 
information that we obtain from you and your child’s hair and plaque samples will not have any 
identifying information.  
 
We would like to store your child's plaque samples for future analyses. We want to know if the 
program changed the types of bacteria in your child's mouth. The reason we are storing the samples 

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is that we currently do not have funding to analyze the plaque samples. Regardless of future 
analyses, all plaque specimens collected will be destroyed by 2027. If you don't want your child's 
plaque samples stored, they can still be in the study. It will not change their participation. You may 
ask to have your child's samples removed from our freezers at any time. Call Dr. Donald Chi, at 
206-616-4332. 
 
 
I agree to have my child’s plaque samples stored for future analyses. 
 
 
Participant Initials:___________  
 
 
I DO NOT agree to have my child’s plaque samples stored for future analyses.  
 
 
RESEARCH-RELATED INJURY  
If you think you have been harmed from being in this research, contact Dr. Donald Chi at 1-206-
616-4332 or e-mail him at dchi@uw.edu or Dr. Joseph Klejka, YKHC Vice President of Quality, 
in Bethel at (907) 543-6028.  
  
   
 
Printed name of study staff obtaining consent 
          Signature 
 
 
Date
 
  
  
Participant’s statement  
This study has been explained to me. I volunteer to take part in this research. I have had a chance 
to ask questions. If I have questions later about the research, or if I have been harmed by 
participating in this study, I can contact one of the researchers listed on the first page of this 
consent form. If I have questions about my rights as a research participant, I can call the 
University of Washington Human Subjects Division at (206) 543-0098 or call collect at (206) 
221-5940. I will receive a copy of this consent form.  
  
  
 
Printed name of participant 
 
 
 
     Signature of participant 
                              
Date 
 
 
_____________________________________________________________________________ 
Home address 
 
 
 
                                               Phone number 
  
  
_____________________________________________________________________________  
Printed name of Yup’ik translator                                 Signature of translator                   Date  
 
 
Copies to:  Researcher | Participant  

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APPENDIX L: ADULT CONSENT FORM (CONTROL) 
Study Participation Consent & Parental Permission Form: Control Arm  
Reducing Sugared Fruit Drinks in Alaska Native Children  
Main Researchers: Dr. Donald Chi, Professor, University of Washington, School of Dentistry, 
Department of Oral Health Sciences, 206-616-4332  
  
Researchers’ Statement  
We are asking you and your child to be in a research study.  The purpose of this consent form is 
to give you the information you’ll need to help you decide if you want to be in the study or 
not.  Please read the form carefully.  You may ask any questions about the research or this 
form.  When we have answered all your questions, you can decide if you want to be in the study 
or not.  This process is called “informed consent.”  We will give you a copy of this form for your 
records.  
  
PURPOSE OF THE STUDY  
The study goal is to learn if a community program can help Yup’ik children to drink less sugary 
drinks and have fewer cavities. In the study, participants assigned into either an intervention 
community (receive the program first) or a control community (receive the program later). Your 
community has been assigned to the control community. That is, you and your child will not 
receive the program at first. But will have the option to receive the program at the end of the 
study. This way, we can see if the program worked.  
  
STUDY PROCEDURES  
The study will last about one year. We will ask you and your child to join us for a meeting at the 
Community Clinic 5 times.  A trained staff person will ask you questions about your children’s 
diet, measure your child’s weight, use scissors to cut about 20 strands of hair from yourself and 
your child and collect an oral plaque specimen using a swab.  Each visit will last up to 1 and 1/2 
hours. You will receive a $25 store gift card per child after completing each visit. If you and your 
child make all 5 phone visits, you will receive a $50 bonus gift card for each child after the last 
visit.   
  
At the end of the study, you and your child will have the option to receive the program. A trained 
Community Health Worker (CHW) will visit you and your child 9 times during the 6-month 
study period. Each visit will last 5 to 30 minutes, with about 2-3 hours total. In the first visit, we 
will show information about fruit drinks and cavities. In the second visit, we will introduce 
sugar-free drinks. During the third to fifth visits, we will work with you to improve ways to get 
your child to accept healthier drinks. After that, there will be 4, 5-minute check-ins to see your 
progress in the program. In case there is a Covid-19 risk at the time of these visits, the CHW will 
either conduct the visits entirely by internet using a tablet or will visit your home using a mask 
and other precautions such as social distancing. .   
  
RISKS, STRESS, OR DISCOMFORT  
You may feel uncomfortable participating in our study in some situations. First, in some cases, 
when children have too many sugar-free fruit drinks, they might have an upset tummy or runny 

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stool. These side effects may occur in adults as well. Sugar-free fruit drinks are FDA-approved 
and safe for children when they drink the right amount. To be safe, families who participate in 
our program should follow the mixing instructions. Caregivers need to keep an eye on the 
number of sugar-free drinks they and their child have.   
  
Second, there is a chance that other community members may be aware of your participation in 
our study. That may make you feel uncomfortable. However, your personal information will be 
securely stored. We will not share your information with anyone besides our study staff.   
  
Third, you and your children may feel uncomfortable about  providing your weight, hair and oral 
plaque samples. You may also feel uncomfortable sharing what your children ate. If you or your 
children feel any discomfort, you may stop participating at any time. Your decision will not 
change the care that you and your child receive from YKHC. You and your child may say no to 
any part of the study. You and your child are free to drop off from this study at any time without 
penalty or loss of your current benefits.  
  
BENEFITS OF THE STUDY  
Direct benefits include receiving oral health information and counseling. You will also receive 
free sugar-free drink samples. You and your child may or may not experience a direct health 
benefit. However, by switching from sugared-fruit drinks to sugar-free fruit drinks, we expect 
your child to have less sugar intake and fewer cavities.   
  
SOURCE OF FUNDING  
The study is funded by the National Institutes of Health.  
  
CONFIDENTIALITY OF RESEARCH INFORMATION  
Information about this study will be available on http://www.clinicaltrials.gov, as required by 
U.S. Law. This website will not include information that identify you. You can search this Web 
site at any time.  
  
You and your children’s information are confidential. The samples and information you and your 
child provide will be stored with only an identification number. Your and your child’s name will 
not appear on the samples and information. Only de-identified information and samples will be 
provided to the researcher doing the analysis. Your name on the consent form will be kept 
separate from the information you provide for the study. Identifying information will be stored in 
locked file cabinets at the University of Washington.   
  
We submit research findings to the YKHC Board for review and approval before we make them 
public in professional journals, other news media, or presentations. When research findings are 
reported in a professional setting, such as in a medical journal or at a scientific meeting, we will 
not identify you and your community.   
  
We have a Certificate of Confidentiality from the federal National Institutes of Health. This 
helps us protect your privacy. The Certificate means that we do not have to give out identifying 

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information about you even if we are asked to by a court of law. We will use the Certificate to 
resist any requests for identifying information.   
  
We can’t use the Certificate to withhold your research information if you give your written 
consent to give it to an insurer, employer, or other person. Also, you or a member of your family 
can share information about yourself or your part in this research if you wish.  
  
There are some limits to this protection. We will voluntarily provide the information to:  
• 
a member of the federal government who needs it in order to audit or evaluate the 
research;  
• 
individuals at the University of Washington, the funding agency, and other groups 
involved in the research, if they need the information to make sure the research is being done 
correctly;  
• 
the FDA, if required by the FDA;  
• 
state or local authorities, if we learn of child abuse, elder abuse, or the intent to harm 
yourself or others.  
  
  
Government or university staff sometimes review studies to make sure they are being done safely 
and legally.  If a review of this study takes place, your records may be examined.  The reviewers 
will protect your privacy.  The study records will not be used to put you at legal risk of harm.  
  
USE OF INFORMATION AND SPECIMENS  
The information you provide in this study may be used for future research studies related to oral 
health. It is also possible that in the future we may want to use or share study information that 
might identify you. If we do, we will obtain additional consent from you at that time.   
You and your child’s hair and oral plaque samples belong to you. These samples will be stored at 
UW and UAF. All the samples are stored with only an identification number. Your and your 
child’s name will not appear on your samples. Analyses of your hair samples will be conducted 
under the direction of Dr. Diane O'Brien, a collaborator on this project. Plaque samples will be 
stored at UW in a secure freezer for analysis at a later date. This research does not involve giving 
treatment or other medical care as a part of the study. It only involves using this information to 
better understand sugar intake and cavities among Alaska Native children. You and your child's 
hair samples will be destroyed after analysis; there will not be any remaining unused samples. 
The information that we obtain from you and your child’s hair and plaque samples will not have 
any identifying information.  
 
We would like to store your child's plaque samples for future analyses. We want to know if the 
program changed the types of bacteria in your child's mouth. The reason we are storing the samples 
is that we currently do not have funding to analyze the plaque samples. Regardless of future 
analyses, all plaque specimens will be destroyed by 2027. If you don't want your child's plaque 
samples stored, they can still be in the study. It will not change their participation. You may ask to 
have your child's samples removed from our freezers at any time. Call Dr. Donald Chi, at 206-
616-4332. 
 
 
I agree to have my child’s plaque samples stored for future analyses. 

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Participant Initials:___________  
 
 
I DO NOT agree to have my child’s plaque samples stored for future analyses.  
 
  
RESEARCH-RELATED INJURY  
If you think you have been harmed from being in this research, contact Dr. Donald Chi at 1-206-
616-4332 or e-mail him at dchi@uw.edu or Dr. Joseph Klejka, YKHC Vice President of Quality, 
in Bethel at (907) 543-6028.  
  
  
 
Printed name of study staff obtaining consent 
          Signature 
 
 
Date 
  
  
Participant’s statement  
This study has been explained to me. I volunteer to take part in this research. I have had a 
chance to ask questions. If I have questions later about the research, or if I have been 
harmed by participating in this study, I can contact one of the researchers listed on the first 
page of this consent form. If I have questions about my rights as a research participant, I 
can call the University of Washington Human Subjects Division at (206) 543-0098 or call 
collect at (206) 221-5940. I will receive a copy of this consent form.  
  
  
 
 
Printed name of participant 
 
 
Signature of participant 
             
Date                   
 
 
 
_______________________________________________________________________ 
Home address 
 
 
 
                                               Phone number 
  
  
  
  
_____________________________________________________________________________  
Printed name of Yup’ik translator                                 Signature of translator                   Date  
 
 
  
Copies to:  Researcher | Participant  
 
 
 

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APPENDIX M: ADULT CONSENT FORM (CONTROL – MODIFIED INTERVENTION) 
Study Participation Consent & Parental Permission Form: Control Arm – 
Modified Intervention  
 Reducing Sugared Fruit Drinks in Alaska Native Children   
Main Researchers: Dr. Donald Chi, Professor, University of Washington, School of Dentistry, 
Department of Oral Health Sciences, 206-616-4332   
   
Researchers’ Statement   
We are asking you and your child to be in a research study.  The purpose of this consent form is 
to give you the information you’ll need to help you decide if you want to be in the study or not.  
Please read the form carefully.  You may ask any questions about the research or this form.  
When we have answered all your questions, you can decide if you want to be in the study or not.  
This process is called “informed consent.”  We will give you a copy of this form for your 
records.   
   
PURPOSE OF THE STUDY   
The study goal is to learn if a community program can help Yup’ik children to drink less sugary 
drinks and have fewer cavities. Your community was originally assigned to the control 
community. Now you will have the opportunity to receive a modified version of the intervention 
based on information we gathered from the first part of the study.   
   
STUDY PROCEDURES   
The study will last about 6 months. We will ask you and your child to join us at the Community 
Clinic 2 more times after today. A trained staff person will ask you questions about your 
children’s diet, measure your child’s weight, use scissors to cut about 20 strands of hair from 
yourself and your child and collect an oral plaque specimen using a swab. Each visit will last up 
to 1 and 1/2 hours. You will receive a $50 store gift card per child after completing each visit. At 
each visit, we will ask for your feedback about the health program. We would like to audio 
record the conversations if that is okay with you. You can review transcripts of the conversations 
if you would like.     
   
In addition, a trained Community Health Worker (CHW) or University of Washington study staff 
member will contact you and your child 6 times during the 6-month study period.  Each visit will 
last 5 to 30 minutes. The visits may be in person, virtual, or by phone. In the first visit, we will 
show information about fruit drinks and cavities. In the second visit, we will introduce you to 
sugar-free drinks. During the third and fourth visits, we will work with you to improve ways to 
get your child to accept healthier drinks. After that, there will be two brief check-in visits to see 
your progress in the program. In case there is a COVID-19 risk we will use a mask and other 
precautions such as social distancing.   
   
RISKS, STRESS, OR DISCOMFORT   
You may feel uncomfortable participating in our study in some situations. First, in some cases, 
when children have too many sugar-free fruit drinks, they might have an upset tummy or runny 
stool. These side effects may also occur in adults. Sugar-free fruit drinks are FDA-approved and 

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safe for children when they drink the right amount. To be safe, families who participate in our 
program should follow the mixing instructions. Caregivers need to keep an eye on the number of 
sugar-free drinks they and their child have.    
   
Second, there is a chance that other community members may be aware of your participation in 
our study. That may make you feel uncomfortable. However, your personal information will be 
securely stored. We will not share your information with anyone besides our study staff.    
   
Third, you and your children may feel uncomfortable about providing your weight, hair and oral 
plaque samples. You may also feel uncomfortable sharing what your children ate. If you or your 
children feel any discomfort, you may stop participating at any time. Your decision will not 
change the care that you and your child receive from YKHC. You and your child may say no to 
any part of the study. You and your child are free to drop off from this study at any time without 
penalty or loss of your current benefits.   
   
 BENEFITS OF THE STUDY   
Direct benefits include receiving oral health information and counseling. You will also receive 
free sugar-free drink samples. You and your child may or may not experience a direct health 
benefit. However, by switching sugared-fruit drinks to sugar-free fruit drinks, we expect your 
child to have less sugar intake and cavities.    
   
SOURCE OF FUNDING   
The study is funded by the National Institutes of Health.   
   
CONFIDENTIALITY OF RESEARCH INFORMATION   
Information about this study will be available on http://www.clinicaltrials.gov, as required by 
U.S. Law. This website will not include information that can identify you. You can search this 
Web site at any time.   
   
You and your children’s information are confidential. The samples and information you and your 
child provide will be stored with only an identification number. Your and your child’s name will 
not appear on the samples and information. Only de-identified information and samples will be 
provided to the researcher doing the analysis. Your name on the consent form will be kept 
separate from the information you provide for the study. Identifying information will be stored in 
locked file cabinets at the University of Washington.    
   
We submit research findings to the YKHC Board for review and approval before we make them 
public in professional journals, other news media, or presentations. When research findings are 
reported in a professional setting, such as in a medical journal or at a scientific meeting, we will 
not identify you and your community.    
   
We have a Certificate of Confidentiality from the federal National Institutes of Health. This 
helps us protect your privacy. The Certificate means that we do not have to give out identifying 
information about you even if we are asked to by a court of law. We will use the Certificate to 
resist any requests for identifying information.    

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We can’t use the Certificate to withhold your research information if you give your written 
consent to give it to an insurer, employer, or other person. Also, you or a member of your family 
can share information about yourself or your part in this research if you wish.   
   
There are some limits to this protection. We will voluntarily provide the information to:   
• 
a member of the federal government who needs it in order to audit or evaluate the 
research;   
• 
individuals at the University of Washington, the funding agency, and other groups 
involved in the research, if they need the information to make sure the research is being done 
correctly;   
• 
the FDA, if required by the FDA;   
• 
state or local authorities, if we learn of child abuse, elder abuse, or the intent to 
harm yourself or others.   
   
The Certificate expires when the NIH funding for this study ends.  Currently this is March 31, 
2023.  Any data collected after expiration is not protected, as described above.  Data collected 
prior to expiration will continue to be protected.     
   
Government or university staff sometimes review studies to make sure they are being done safely 
and legally.  If a review of this study takes place, your records may be examined.  The reviewers 
will protect your privacy.  The study records will not be used to put you at legal risk of harm.   
   
   
   
USE OF INFORMATION AND SPECIMENS   
The information you provide in this study may be used for future research studies related to oral 
health. It is also possible that in the future we may want to use or share study information that 
might identify you. If we do, we will obtain additional consent from you at that time.    
You and your child’s hair and oral plaque samples belong to you. These samples will be stored at 
UW and UAF. All the samples are stored with only an identification number. Your and your 
child’s name will not appear on your samples. Analyses of your hair samples will be conducted 
under the direction of Dr. Diane O'Brien, our collaborator on this project. Plaque samples will be 
stored at UW in a secure freezer for analysis at a later date. This research does not involve giving 
treatment or other medical care as a part of the study. It only involves using this information to 
better understand sugar intake and cavities among Alaska Native children. You and your child's 
hair samples will be destroyed after analysis; there will not be any remaining unused sample. The 
information that we obtain from you and your child’s hair and plaque samples will not have any 
identifying information.   
  
We would like to store your child's plaque samples for future analyses. We want to know if the 
program changed the types of bacteria in your child's mouth. The reason we are storing the samples 
is that we currently do not have funding to analyze the plaque samples. Regardless of future 
analyses, all plaque specimens collected will be destroyed by 2029. If you don't want your child's 
plaque samples stored, they can still be in the study. It will not change their participation. You may 

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ask to have your child's samples removed from our freezers at any time. Call Dr. Donald Chi, at 
206-616-4332.  
  
I agree to have my child’s plaque samples stored for future analyses.  
  
Participant Initials:___________   
  
I DO NOT agree to have my child’s plaque samples stored for future analyses.   
  
  
RESEARCH-RELATED INJURY   
If you think you have been harmed from being in this research, contact Dr. Donald Chi at 1-206-
616-4332 or e-mail him at dchi@uw.edu or Dr. Joseph Klejka, YKHC Vice President of Quality, 
in Bethel at (907) 543-6028.   
   
    
  
Printed name of study staff obtaining consent           Signature Date    
   
Participant’s statement   
This study has been explained to me. I volunteer to take part in this research. I have had a chance 
to ask questions. If I have questions later about the research, or if I have been harmed by 
participating in this study, I can contact one of the researchers listed on the first page of this 
consent form. If I have questions about my rights as a research participant, I can call the 
University of Washington Human Subjects Division at (206) 543-0098 or call collect at (206) 
221-5940. I will receive a copy of this consent form.   
   
   
   
  
Printed name of participant      Signature of participant                               Date  
  
  
_____________________________________________________________________________  
Home address                                                Phone number  
   
   
_____________________________________________________________________________   
Printed name of Yup’ik translator                                 Signature of translator                   Date   
  
  
Copies to:  Researcher | Participant   
  
 
 
 

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APPENDIX N: ASSENT FORM (INTERVENTION) 
Study Participation Assent to Research Form: Intervention Arm  
Reducing Sugared Fruit Drinks in Alaska Native Children  
Main Researchers: Dr. Donald Chi, Professor, University of Washington, School of Dentistry, 
Department of Oral Health Sciences, 206-616-4332  
  
Researcher’s statement:  
  
My name is [identify yourself to the child by name].  
  
We are asking you to be in a research study. We are trying to introduce a health program to 
help you switch from juices like Tang and Kool-Aid to sugar-free Tang and Kool-Aid.  
  
If you agree to be in this study, we will have 9 visits with you over the next 6 months. We will 
ask you to watch a video about juice and cavities. We will ask you to pick your favorite flavors 
and help make and taste sugar-free juices with your family.   
  
Then we will ask you and your caregiver to come to the clinic 5 times so we can ask you 
questions about foods you have eaten and what you have had to drink in the past 24 hours. We 
will also weigh you, ask for a small sample of hair, and take a dental plaque sample (white sticky 
staff from your teeth that can scratch off) from your mouth.   
  
The benefits of the program include getting oral health information and samples of the sugar-
free juice. If you don’t want to be in the study, you don’t have to participate. Remember, being 
in this study is up to you, and no one will be upset if you don’t want to participate or even if you 
change your mind later and want to stop. You can ask any questions about the study. If you 
have a question later, you can call me [insert telephone number] or ask me next time.  
  
Please talk this over with your parents before you decide whether or not to do this. We will also 
ask your parents if it is okay for you to be in this study. Even if your parents say “yes,” you can 
still decide not to do this.  
   
 
 
 
Printed name of study staff obtaining consent 
          Signature 
 
 
Date 
 
 
 
 
 
 

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Your statement:  
This research has been explained to me. I agree to take part in this study. I have had a chance to 
ask questions. If I have more questions, I can ask the researcher.  
Writing your name at the bottom means that you agree to be in this study. You and your 
parents will be given a copy of this form after you have signed it.  
  
  
 
Printed name of participant 
 
 
 
 
 
 
 
Date 
  
Copies to:   
Participant   
Researcher’s file  
 
 

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APPENDIX O: ASSENT FORM (CONTROL) 
Study Participation Assent to Research Form: Control Arm  
Reducing Sugared Fruit Drinks in Alaska Native Children  
Main Researcher: Dr. Donald Chi, Associate Professor, University of Washington, School of 
Dentistry, Department of Oral Health Sciences, 206-616-4332  
  
Researcher’s statement:  
My name is [identify yourself to the child by name].  
  
We are asking you to be in a research study. We are trying to see if a health program can help 
Yup’ik children to switch from juices like Tang and Kool-Aid to sugar-free Tang and Kool-Aid.  
  
If you agree to be in this study, we will ask you and your caregiver to come to the clinic 5 times 
so we can ask you questions about foods you have eaten and what you have had to drink in the 
past 24 hours. We will also weigh you, ask for a small sample of hair, and take a dental plaque 
sample (white sticky stuff from your teeth that can scratch off) from your mouth.  
  
Then we will visit with you 9 times, if you like us to. We will ask you to watch a video about 
juice and cavities. We will ask you to pick your favorite flavors and help make and taste sugar-
free juices with your family.   
  
The benefits of the program include getting oral health information and samples of the sugar-
free juice. If you don’t want to be in the study, you don’t have to participate. Remember, being 
in this study is up to you, and no one will be upset if you don’t want to participate or even if you 
change your mind later and want to stop. You can ask any questions about the study. If you 
have a question later, you can call me [insert your telephone number] or ask me next time.  
  
Please talk this over with your parents before you decide whether or not to do this. We will also 
ask your parents if it is okay for you to be in this study. Even if your parents say “yes,” you can 
still decide not to do this.  
  
  
  
  
  
 
 
Printed name of study staff obtaining consent 
          Signature 
 
 
Date 
 
 
 
 
 

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Your statement:  
This research has been explained to me. I agree to take part in this study. I have had a chance to 
ask questions. If I have more questions, I can ask the researcher.  
Writing your name at the bottom means that you agree to be in this study. You and your 
parents will be given a copy of this form after you have signed it.  
  
  
  
 
Printed name of participant 
 
 
 
 
 
 
 
Date 
  
Copies to:   
Participant   
Researcher’s file  
 
 

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APPENDIX P: ASSENT FORM (CONTROL – MODIFIED INTERVENTION) 
Study Participation Assent to Research Form:  Control Arm – Modified 
Intervention  
Reducing Sugared Fruit Drinks in Alaska Native Children   
Main Researchers: Dr. Donald Chi, Professor, University of Washington, School of Dentistry, 
Department of Oral Health Sciences, 206-616-4332   
   
Researcher’s statement:   
   
My name is [identify yourself to the child by name].   
   
We are asking you to be in a research study. We are trying to introduce a health program to 
help you switch from juices like Tang and Kool-Aid to sugar-free Tang and Kool-Aid.   
   
If you agree to be in this study, we will have 5-9 visits with you over the next 6 months. We will 
ask you to watch a video about juice and cavities. We will ask you to pick your favorite flavors 
and help make and taste sugar-free juices with your family.    
   
Then we will ask you and your caregiver to come to the clinic 2 times so we can ask you 
questions about foods you have eaten and what you have had to drink. We will also weigh you, 
ask for a small sample of hair, and take a dental plaque sample (white sticky staff from your 
teeth that can scratch off) from your mouth.    
   
The benefits of the program include getting oral health information and samples of the sugar-
free juice. If you don’t want to be in the study, you don’t have to participate. Remember, being 
in this study is up to you, and no one will be upset if you don’t want to participate or even if you 
change your mind later and want to stop. You can ask any questions about the study. If you 
have a question later, you can call me [insert telephone number] or ask me next time.   
   
Please talk this over with your parents before you decide whether or not to do this. We will also 
ask your parents if it is okay for you to be in this study. Even if your parents say “yes,” you can 
still decide not to do this.   
    
  
  
  
Printed name of study staff obtaining consent           Signature Date  
  
  
  
  
  

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Your statement:   
This research has been explained to me. I agree to take part in this study. I have had a chance to 
ask questions. If I have more questions, I can ask the researcher.   
Writing your name at the bottom means that you agree to be in this study. You and your 
parents will be given a copy of this form after you have signed it.   
   
   
  
Printed name of participant Date  
   
Copies to:    
Participant    
Researcher’s file   
  
 
 

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APPENDIX Q: POST-INTERVENTION INTERVIEW GUIDE (6-month) 
An Intervention to Reduce Sugared Fruit Drinks in AK Native Children 
Semi-Structure Interview Script 
6m data collection visit 
 
1. How is everything going with the sugar-free Kool Aid? Good, okay, not good, other (_____) 
a. 
Tell me more (what’s going good, what’s not good, why just ok) 
 
2. Do your children like the sugar-free Kool Aid? Yes, no, other (_______) 
a. 
Is it the same for all your children? If different for children, tell me more. 
b. How about the adults in your family? Do they like them? 
 
3. Have you experienced any difficulties getting your children to drink the sugar-free Kool Aid at home? Yes, No, 
other (_______) 
a. 
If yes, tell me more about barriers encountered. 
b. Have the Community Health Workers been able to help problem solve? 
 
4. Have you used your vouchers at the local store? Yes, no, other (______) 
a. 
Tell me more about any difficulties in redeeming the vouchers 
 
5. Have you been able to purchase additional sugar-free Kool Aid drops at the local store? Yes, no, other (______) 
a. 
Tell me more about your ability to purchase more at your local store 
 
6. Are there times when you give your children regular sugared Kool Aid? Yes, no, other (______) 
a. 
Tell me more (when, reason why). 
 
7. Will you continue giving your children the sugar-free Kool Aid? Yes, no, other (______) 
a. 
Tell me more (if yes, why? If no, why?) 
b. Is there anything that could make this easier for you? 
 
8. Has the program changed what your child drinks at home? Yes, no, other (______) 
a. 
Tell me more (less sugared Kool Aid, same as before the program) 
 
9. What’s been your overall experience with our program? Good, okay, not good 
a. 
Tell me more. 
 
10.  Is there anything about the program you would change? Yes, no, other (______) 
a. 
Tell me more (what would you change, what would you keep the same) 
 
 
 
 

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APPENDIX R: POST ST-INTERVENTION INTERVIEW GUIDE [INTERVENTION] (12-
month)  
An Intervention to Reduce Sugared Fruit Drinks in AK Native Children  
Semi-Structure Interview Script   
12M data collection visit [INTERVENTION]  
   
[Sugar-free Kool-Aid refers to the drops we provided as part of the program]   
    
1. Will you continue giving your children the sugar-free Kool Aid drops? (YES, NO, 
OTHER) [Check their response on their answer sheet]  
  
a. 
If YES:   
i.Tell me more about why.   
ii.What would it easier for you to continue?   
iii.What would make it difficult to continue?   
   
b. 
If NO:   
i.Why not?   
   
2. Have you purchased additional sugar-free Kool Aid drops at the local store? (YES, NO, 
OTHER) [Check their response on their answer sheet]  
  
a. 
If YES:   
i.About how many times did you buy them?   
ii.Were they easy to find?   
iii.What do you think about the price?   
iv.Do you plan on buying more in the future?   
  
b. 
If NO:   
i.Why not?   
ii.Have you purchased them somewhere else?   
   
3. Has the program changed what your children drink at home? (YES, NO, OTHER)   
a. 
In what ways has the program changed what your children drink at home?   
If more than one child in the home: Is this the same for all your children?    
   
4. What’s been your overall experience with our program? (GOOD, BAD, OTHER)   
a. 
Tell me more about why you said [GOOD, BAD, OTHER]   
     
5.  Another part of the program involved collecting data from you and your child/children. Tell me 
about your experiences with the data collection part of the study. (GOOD, BAD, OTHER).   
a. 
Tell me more (i.e., specific procedures (hair and plaque collection), time)   
   
6. Is there anything about the program you would change? (YES, NO, OTHER)   
a. 
Tell me what you would change (and what you would keep the same).   
b. 
How long does it take for your visits? (Tell me more…)  
c. 
How can we make the program visits easier and pleasant? (Tell me more…)  
  
7. Would you recommend that other communities start this program? (YES, NO, OTHER)   
a. 
Why or why not?   
 

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APPENDIX S: POST-INTERVENTION INTERVIEW GUIDE [CONTROL] (12-month)  
 
An Intervention to Reduce Sugared Fruit Drinks in AK Native Children  
Semi-Structure Interview Script   
12m data collection visit [CONTROL]  
   
[Sugar-free Kool-Aid refers to the drops we provided as part of the program]   
   
  
1. Part of the program involved collecting data from you and your child/children.   
Tell me about your experiences with the data collection part of the study.   
(GOOD, BAD, OTHER).   
a. 
Tell me more (i.e., specific procedures (hair and plaque collection), time)   
   
2. Is there anything about the program you would change?   
(YES, NO, OTHER)   
a. 
Tell me what you would change (and what you would keep the same).   
b. 
How long does it take for your visits? (Tell me more…)  
c. 
How can we make the program visits easier and pleasant? (Tell me more…)  
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX T: POST-INTERVENTION INT. CATEGORIAL QUESTIONS FOR PARTICIPANT 
(12-month) 
 
 
 
 
 

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APPENDIX U: BEVERAGE QUESTIONNAIRE 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX V: INSTRUCTIONS FOR COLLECTION OF HAIR SAMPLES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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