iSIPsmarter: An RCT to Evaluate the Efficacy, Reach, and Engagement of a Technology-based Behavioral and Health Literacy Intervention to Reduce Sugary Beverages Among Rural Appalachian Adults
Phase: NA
Conditions: Diet Habit, Sugar-Sweetened Beverages
Sponsor: University of Virginia

iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a technology-based 
behavioral and health literacy intervention to reduce sugary beverages among rural 
Appalachian adults 
 
 
Study  Protocol 
 
NCT#:  NCT05030753 
 
Date:  March 25,  2022

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
Version Date: 03-25-2022 
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PROTOCOL 
 
Background 
1. Provide the scientific background, rationale and relevance of this project.   
INSTRUCTIONS 
• This should include a referenced systematic evidenced-based review when possible.   
• If this study involves qualitative research explain the major constructs of your study.  
• Do not state in this section what you plan to do in this study.  This information 
should be entered later under “What will be done in this protocol?” 
• Do not include the bibliography in this section. 
• For studies submitted under the Expedited review criteria, this section need not be 
more than a few paragraphs.  
• For those studies where data will be analyzed collaboratively by multiple sites doing 
a similar study for which there is no common protocol (Collaborative Site Analysis 
Study) include a description of the common scientific goals/ procedures/data points. 
• If this is a FIVE YEAR UPDATE make sure the information throughout the protocol 
includes the most current information.  
Answer/Response:  
 
In the United States (US), sugar-sweetened beverages (SSB) is the largest single food source 
of calories and contributes approximately 7% of total energy intake.1 The intake of SSB is 
disproportionately high in in the southwest Virginia region of Appalachia with data indicating 
that adults drink ~38 ounces (~475 calories) of SSB per day2 and SSB contributes about 14% of 
total daily energy intake.3, 4 This intake is more than double national average intakes1 and more 
than four times the recommended amount.5, 6 There are also strong and consistent data 
documenting relationships among high SSB consumption and numerous health issues, including 
obesity, diabetes, some obesity-related cancers, heart disease, hypertension, and dental 
decay.7-17 2122 
Further compounding the challenges of SSB, the Appalachian region lacks access to 
providers, medical services, and evidence-based behavioral prevention programs.23-25 Although 
there is a large body of literature documenting the effectiveness of health-related Internet-
based intervention, including for nutrition-related outcomes,26-32 there is limited data on 
Internet-based interventions in medically-underserved rural regions, especially in Appalachia. 
Because of this gap, little is known about how rural, Appalachian adults may engage with 
technology-based behavioral programs. Historically, extending evidence-based interventions 
into Appalachia has been hindered by lack of providers, physical barriers (e.g. rural geographical 
dispersion, limited transportation resources), and a digital divide.23, 33 Given the progress in 
shrinking the digital divide in recent years,34-37 the timing is ideal to evaluate technology-based 
behavioral interventions in this region. 
The current proposal is designed to target this major SSB dietary risk factor and public 
health challenge, as well as address notable gaps in the rural e/m-Health literature. iSIPsmarter 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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is a technology-based behavioral and health literacy intervention targeting SSB reduction that 
has already been developed by this research team. It is comprised of six Internet-delivered 
Cores, an integrated short message service (SMS) strategy to engage users in tracking SSB 
behaviors, and the incorporation of a cellular enabled scale for in-home weight tracking. 
iSIPsmarter is a highly interactive, structured, and self-guided program that uses strategies 
previously proven to promote behavior change. Knowing some participants have difficulties 
staying engaged with technology-based interventions,38-41 iSIPsmarter also incorporates a 
stepped care approach to users who struggle to complete components of the intervention. 
Importantly, this iSIPsmarter proposal builds on our team’s expertise with e/m-Health 
interventions and decades of SSB behavioral intervention research in rural Appalachia. 
Specifically, iSIPsmarter has been adapted from our evidence-based SSB reduction program for 
Appalachian adults, SIPsmartER,4, 42-52 that included in-person classes and interactive voice 
response calls. In the full-scale RCT, SIPsmartER improved 6-month SSB behaviors43 and 
sustained improvements across a 12-month maintenance phase.50 Furthermore, SIPsmartER 
significantly decreased weight,43 and improved overall dietary and beverage quality,4, 44 an 
added sugar biomarker,45 and quality of life (QOL).43 The effective SIPsmartER content and 
behavioral change strategies have been carried forward in the adaption process and user-
centered development of iSIPsmarter. 
Objectives/Hypothesis  
INSTRUCTIONS:   
If this study involves biomedical research clearly state the objectives and hypotheses and 
clearly define the primary and any secondary outcome measures.  If this study involves 
qualitative research clearly state your research hypothesis or question.  
 
This section should not include information already included in other sections such as 
background information or information from the procedures section.  
Answer/Response: The purpose of this study is to help people decrease their sugary drinks.  The 
study is also trying to help people improve their diet, weight, and quality of life. 
PRIMARY AIM: To determine the efficacy of iSIPsmarter at reducing SSB consumption. We 
hypothesize that iSIPsmarter will be more efficacious at reducing SSB consumption than a static 
patient education (Sugary Drink Education Website) website at post assessment. 
 
SECONDARY AIMS: Using iSIPsmarter, we will: 
• Determine its efficacy on secondary outcomes (overall dietary quality, weight, QOL, 
behavioral theory constructs) and the maintenance of all primary and secondary outcomes 
at 6- and 18-months follow-up. 
• Evaluate its reach and representativeness. 
• Describe patterns of user engagement (number of log-ins, number of cores completed, 
diary entries). 
Estimate the added cost of delivering stepped care in iSIPsmarter and its associated value 
to intervention adherence and efficacy outcomes.  

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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EXPLORATORY AIMS:  
• Explore the influence of engagement on efficacy outcomes and explore mediators to 
engagement and efficacy outcomes. 
 
Study Design: Biomedical 
1.  Will controls be used? 
Answer/Response: Yes 
 
►IF YES, explain the kind of controls to be used. 
Answer/Response: 
The Sugary Drink Education website will include scientifically accurate information that is 
typical of nutrition education websites and relevant content as adapted from our SIPsmartER 
intervention. The Sugary Drink Education website will include information about SSB 
recommendations, types of SSB and portion size, SSB-related health risks, energy balance 
information, identifying motivators and barriers to reducing SSB intake, interpreting SSB 
nutrition labels, and recognizing media influences and misclaims in SSB advertisements, as well 
as printable forms to track SSB and weight. Unlike iSIPsmarter, the content will not be tailored 
and will be presented all at once.  
 
 
2. What is the study design?  
Example:  case series, case control study, cohort study, randomized control study, 
single-blind, double-blind, met-analysis, systematic reviews, other.  You may also view 
the IRB-HSR Learning Shot on this topic to help you answer this question.  
(http://www.virginia.edu/vpr/irb/learningshots/Writing_protocol_June09/player.html 
Answer/Response: 
This is a randomized controlled trial. The overall goal is to examine the efficacy of iSIPsmarter 
in a 2 group [iSIPsmarter vs. Sugary Drink Education website] by 4 assessment (Pre, Post, 6- and 
18-month follow-up) design: 
 
3. 
Does the study involve a placebo? 
Answer/Response: No 
 
►IF YES, provide a justification for the use of a placebo 
Answer/Response: 
 
Human Participants 
Ages: __at least 18 years old__ 
Sex: 
_male and female___ 
Race: _all races, no race inclusion/exclusion criteria_ 
 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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Subjects- see below 
INSTRUCTIONS: For question 1-4 below insert an exact #.  Ranges or OPEN is not 
allowed.  This # should be the maximum # you expect to need to enroll (i.e. sign 
consent) If you are only collecting specimens the number of participants should equate 
to the # of specimens you need.  If you are collecting only data from a chart review the 
number should designate the number of subjects whose medical records you plan to 
review.  Age/ Sex/Race criteria should designate the demographics of participants from 
whom you will obtain the specimen/data. 
1.  Provide target # of subjects (at all sites) needed to complete protocol. 
INSTRUCTIONS: If this is NOT a database protocol, this number should be the same as 
the number of subjects needed to obtain statistically significant results.    
Answer/Response:  97 participants per condition are needed to complete the protocol 
(Total = 194) 
 
2.  Describe expected rate of screen failure/ dropouts/withdrawals from all sites.   
Answer/Response:  We anticipate a 20% attrition at the post intervention assessment 
 
3.  How many subjects will be enrolled at all sites?    
INSTRUCTIONS: This number must be the same or higher than the # from question # 1 
in order to account for the # of screen failures, dropouts, withdrawals described in 
question # 2.  
Answer/Response:  122 participants per condition are needed to enroll in the study  
(Total = 244) 
 
4.  How many subjects will sign a consent form under this UVa protocol?     
INSTRUCTIONS: If the protocol does not have a consent form- the number listed here 
should reflect such things as the number of subjects from whom specimens will be 
obtained, the number of charts to be reviewed etc.  
Answer/Response:  244 
Inclusion/Exclusion Criteria 
INSTRUCTIONS: 
• The inclusion and exclusion criteria should be written in bullet format. 
• This item applicable if the study will require consent (verbal or written).        Unless there 
is a scientific reason for not recruiting a certain type of vulnerable population(e.g. not 
enrolling fetuses, neonates or children in a study regarding Alzheimer’s) list the 
following vulnerable populations under either Inclusion or Exclusion criteria below:  
pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, 
educational or economically disadvantage, non- English speaking subjects . 
• If you will not enroll subjects who do not speak English because certain procedures 
cannot be carried out if the subject does not speak English (e.g. a survey is not validated 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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in other languages) insert the following as an Inclusion Criteria:  Willingness and ability 
to comply with scheduled visits and study procedures.   
• If this is a collection of only retrospective* specimens or data, the inclusion criteria must 
include a start and stop date for when specimens/ data will be collected.   
• The stop date must be prior to the version date of this protocol. 
• *Retrospective:  all specimens are in a lab at the time this protocol is approved by the 
IRB.  All data exists in medical records or records from previous studies at the time this 
protocol is approved by the IRB.   
1.  List the criteria for inclusion  
Answer/Response: 
• English speaking  
• at least 18 years old 
• consume >200 kcals of SSB/day  
• live in the targeted southwest Virginia or surrounding Appalachia county region 
• be able and willing to access an internet-enabled device at least one time per week  
• willing to receive text message reminders to complete program tasks  
• willing to check emails regularly for reminders to complete program tasks 
• willing and able to comply with study procedures  
 
2.  List the criteria for exclusion 
Answer/Response: 
• Non-English speaking  
• ages <18 years 
• consume <200 kcals of SSB/day  
• live outside of the targeted southwest Virginia or surrounding Appalachia county region 
• unable to access an internet-enabled device at least one time per week  
• unwilling to receive text message reminders to complete program tasks  
• unwilling to check emails regularly for reminders to complete program tasks 
• unwilling or unable to comply with study procedures  
 
3.  List any restrictions on use of other drugs or treatments. 
INSTRUCTIONS: List only those drugs or treatments that are prohibited while on study, not 
those listed as an exclusion criteria.  
Answer/Response: None 
 
Statistical Considerations 
1. 
Is stratification/randomization involved? 
Answer/Response: No 
 
►IF YES, describe the stratification/ randomization scheme. 
INSTRUCTIONS: 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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The stratification factors and/or the randomization plan should be identified. If there is 
no randomization component or important patient characteristics that will be used in 
treatment allocation or data analysis, a statement to this effect should be included. 
 
Stratification factors: These are pretreatment patient characteristics which could be 
balanced across treatment arms by design or may be used to determine starting dose or 
treatment allocation. 
 
If randomization is going to be used, the details of the randomization plan should be 
described.  
 
The description should include: 
--the method and timing of randomization 
--the type of randomization scheme that will be used in the study 
--whether or not the randomization masked/blinded/if so, then to whom is it 
masked/blinded 
--who has access to the randomization scheme 
Answer/Response: 
 
►IF YES, who will generate the randomization scheme?  
_____ Sponsor 
__X___ UVa Statistician.   Insert name Answer/Response: Dr. Wen You 
_____ UVa Investigational Drug Service (IDS) 
_____ Other:  Specify   Answer/Response: 
 
2.  What are the statistical considerations for the protocol?  
The objectives section and the statistical section should correspond, and any objective for 
which analysis is unfeasible should be deleted.  Also, the estimates and non-statistical 
assumptions of the statistical section should be supported by discussion in the background 
section. 
 
The answer to this question should include: 
--Study Design/Endpoints 
--Recap of study objectives and endpoint definitions. An assessment of how study objectives 
will be assessed by identifying & defining which endpoints will be used to assess each 
component of the study objectives. 
--The study design should include contingencies for early stopping, interim analyses, 
stratification factors (If applicable), and any characteristics to be incorporated in analyses.  
--The power/precision of the study to address the major study endpoint(s), the assumptions 
involved in the determination of power/precision. 
--If statistical hypothesis testing is included then specify the null and alternative hypotheses, 
the test statistic, and the type I and II error rates 
--If precision of an estimate, then provide a definition for precision 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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--If other, then specify  
Answer/Response: 
Our efficacy analysis will be on the individual level and the analysis will address potential self-
selection occurrence across program participation, engagement, and stepped care provision. 
Appropriate descriptive, parametric, and non-parametric statistical methods will be used to 
summarize continuous and categorical variables between the intervention conditions at 
baseline. Data will be examined for the presence of outliers, violations of normality (for 
continuous variables), and missing data. Major violations of normality will be corrected with an 
appropriate transformation procedure. All analysis will use county-level cluster robust standard 
error adjustment to account for correlation of behavioral outcomes within the county who are 
likely to share similar food and beverage preferences, food environments, and SSB 
consumption norms. 
 
 
3.  Provide a justification for the sample size used in this protocol.   
Include sample size calculations or statistical power estimation.  If not applicable, please 
provide explanation.   
Also include the anticipated accrual rate, the accrual goal for the study, including accrual goals 
by strata if appropriate, adjustments for drop-outs etc. and study duration. 
Answer/Response: 
This iSIPsmarter power calculation is based on our SIPsmartER effectiveness trial that found an 
ES of 0.55 for the primary 6-month SSB outcome [i.e., SIPsmartER decreased SSB intake by 227 
(95% CI=-326, -127, p<0.001) kcals/day when compared to the decrease of 53 (95% CI=-88, -17, 
p<0.01) kcals/day among MoveMore (p<0.001); see Section 4b]. We anticipate that iSIPsmarter 
will lead to a change at least as strong as that found with SIPsmartER, given the added 
enhancements of stepped-care, daily SSB tracking, and the shorter time to follow-up 
assessment. Yet, one might expect a somewhat smaller iSIPsmarter ES given the remote 
delivery, more limited human exchange, and less discrepancy of provision of content provided 
between the experimental and control conditions (PE website provides SSB content). Based on 
these considerations, we are powering our study to detect a reasonably conservative ES of 0.4. 
To achieve 80% power with a 0.05 type I error rate, 97 participants/condition are needed. 
Accounting for 20% attrition at the post intervention assessment, a total of 122 
participants/condition will be enrolled (Total enrolled = 244). 
 
4.  What is your plan for primary variable analysis? 
Include primary outcome(s)/predictor variable(s), statistical methods/models/tests to be 
employed, or descriptive summaries as appropriate.  If not applicable, please provide 
explanation.   
Answer/Response: 
A General Linear Mixed Model (GLMM) will be employed to control errors of non-
independence and heteroscedasticity caused by individual and county heterogeneity, and 
potential covariates identified a priori based on the existing literature and theory that are 
relevant to SSB consumption outcome, and include: age, gender, race/ethnicity, income level, 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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education level, health literacy level.53-56 Furthermore, GLMM will allow us to model attrition 
specifically through a structural approach. A time indicator that identify post-assessment time 
points will be created and included in the model with baseline as the base. A treatment group 
indicator will be included to identify iSIPsmarter group with PE group as the base. The time and 
group interaction term will be included in the model with its coefficient capturing the over time 
relative effect (iSIPsmarter vs. PE) on SSB intakes. The model will allow county level random 
effects to capture the source of variability that comes from county-level unobserved 
differences. 
 
5.  What is your plan for secondary variable analysis?  
Include the following:  
--Secondary outcome(s)/predictor variables, statistical methods/models/tests to be employed, 
or descriptive summaries as appropriate.  If not applicable, please provide explanation.  
--For phase III studies, the power/precision of the study to address the secondary objective(s). 
Answer/Response: 
The multi-level mixed effect model used for the primary aim will be modified to assess 
secondary outcomes and maintenance time points. For those discrete outcomes, nonlinear 
mixed effect models will be used with appropriate link functions chosen to capture the 
nonlinear outcomes’ distribution; additional time indicators will be added to the model that will 
capture 6- and 18-months follow-up assessment time points. Due to the multiple outcomes 
treatment effect analysis nature, we will follow the multiple testing correction procedures in 
mixed models proposed in Joo et al.57 and examine the potential efficiency gained through 
hierarchical Bayesian procedure in Gelman et al.58 SA2: Similar to our teams’ other reach 
papers,49, 59-61 reach will be analyzed following recommendations of Glasgow et al.62 
Participation rate will be determined by dividing the total number of enrolled participants by 
the total number eligible to enroll. Representativeness will be assessed by comparing 
demographics of those enrolled to: 1) those screened, eligible, and not enrolled and 2) the 
demographics of the targeted Appalachia Virginia region using county-level Census Bureau 
data.63 SA3: We will report descriptive statistics and qualitative findings on patterns of user 
engagement (e.g., number of log-ins, number of cores completed, diary entries), requirement 
for stepped care, and participants’ perceptions of the intervention (e.g., usability, satisfaction, 
and barriers to web program use). SA4: The incremental cost of iSIPsmarter with stepped care 
relative to the PE website will be assessed. Since the primary cost additions are due to the 
added stepped care component of iSIPsmarter, we will focus on those associated added costs, 
including time to construct and send texts and time to prepare for and talk on the phone.64 
Beyond those incremental costs, we will also capture costs per participant and explore marginal 
costs per SSB kcal reduction. Non-research-related intervention resource use will be valued at 
competitive market rates (e.g., the labor costs of stepped care will be valued at the market 
wage rate for the associated occupation). All costs will be estimated and evaluated in the 
constant dollars adjusted by appropriate index. Recognizing that we do not have a second 
treatment group without stepped care enhancement, we will use Monte Carlo simulations to 
alter adherence rate and changes in characteristics of the participants in order to simulate 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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changes in stepped care demands.65 This will provide necessary parameters for a future full-
scale effectiveness trial that assess cost-effectiveness of iSIPsmarter in rural systems.  
Exploratory Aim (EA)1: The GLMM will be expanded to include engagement variables (e.g., 
number of log-ins/core completion) and explore engagement effect on efficacy outcomes. 
Furthermore, the GLMM will be modified to explore potential mediating effects of variables 
(e.g., behavioral theory constructs) on engagement and efficacy outcomes. Specific procedure 
for testing mediation will closely follow suggestions of Zhao et al.66 and Imai et al.67 Although 
not specifically powered for these exploratory mediation analyses, findings will provide 
necessary preliminary results to inform a future effectiveness trial in terms of block 
randomization and targeted power calculation.  
 
6. Have you been working with a statistician in designing this protocol? 
Consultation with a professional statistician is highly recommended to ensure good science of 
the study and facilitate the review process.  
 
Answer/Response: Yes 
IF YES, what is their name?   
Answer/Response: Dr. Wen You 
 
7.  Will data from multiple sites be combined during analysis?   
Answer/Response: No 
INSTRUCTIONS:  IF YES, answer the following questions 
7(a).  Does the study involve randomization?   
Answer/Response:  
IF YES, will randomization be done at each site or among sites?   
Answer/Response:  
 
7(b).  Has the sample size calculation considered the variation among sites?  
Answer/Response:  
 
7(c).  When combining the data from multiple sites to assess the study results, is the 
effect of the treatment to be tested (or the association to be tested) assumed to be the 
same across sites or vary among sites? What is the modelling strategy? 
Answer/Response:  
 
 
7(d). Is there a common protocol used in all sites?  
Answer/Response: 
IF NO, how will differences among sites, such as those related to the 
implementation, inclusion criteria, patient characteristics, or other sites 
characteristics, be considered to assess the study results? 
Answer/Response: 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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Study Procedures-Biomedical Research 
1.  What will be done in this protocol?    
INSTRUCTIONS:  
This should include everything that will be done as part of this protocol. Do not repeat 
information that is included in other sections such as Background or Hypothesis 
sections.  
This section should include an indication of which research interventions if any offer a 
prospect for direct benefit and which interventions (invasive measurements, collection 
of blood, tissue, data, surveys, etc.) are being done solely to answer a research question 
and generate generalizable knowledge. If the interventions done solely for research 
purposes are associated with greater than minimal risk they need to be justified. 
Describe and justify any control and experimental arm and include method, dose, and 
duration of drug administration. Reference any claim of clinical equipoise if applicable.   
 
If you are obtaining specimens or data, provide information regarding the type of 
specimen/data, amount of specimen needed and how the specimen/data will be 
obtained and what analysis will be done with the specimen/data. 
 
Special note for studies with waiver of consent/waiver of documentation of consent:  
Include a statement regarding how subjects will be recruited. For other studies this 
information is captured in Recruitment does not need to be duplicated in this section. 
Answer/Response:  
 
The intervention will be tested in a 2 group (iSIPsmarter vs. Sugary Drink Education website) by 
4 assessment (pre, post, 6-months post, and 18-months post). 
 
After the initial eligibility screening and consent are performed, the following procedures are 
conducted for research purposes: 
 
Step 
Weeks Study Phase 
What will I do? 
Time 
required? 
1 
0 
Screening 
Complete Interest Form 
Review/Sign Consent Form 
Phone Interview & Dietary Recall Telephone Call 1 
60 
minutes 
2 
2 
Baseline 
Complete Questionnaire 
Dietary Recall Telephone Call 2 
Weight with Cellular Scale 
90 
minutes 
 
3 
3-12 
Intervention 
Use assigned website 
 
4 
12 
Post- 
Assessment  
9 weeks 
Complete Questionnaire 
Dietary Recall Telephone Call 1 
Dietary Recall Telephone Call 2 
Weight with Cellular Scale 
90 
minutes 
 
5 
38 
Post-
Complete Questionnaire 
90 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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Assessment  
6 months 
Dietary Recall Telephone Call 1 
Dietary Recall Telephone Call 2 
Weight with Cellular Scale 
minutes 
 
 
6 
96 
Post- 
Assessment  
18 months 
Complete Questionnaire 
Dietary Recall Telephone Call 1 
Dietary Recall Telephone Call 2 
Weight with Cellular Scale 
90 
minutes 
 
OUTCOME MEASURES 
• 
SEE ATTACHMENTS: 15337 iSIP Outcome Assessment Packet (and Table below) 
o The BEV-Q 15, 24-hour dietary recalls, objective body weights, quality of life, and validated 
measures that have been used in our prior SIPsmartER and Internet-based interventions will be 
administered. 
o The BEV-Q 15 and two 24-hour dietary recalls will be used to understand changes in beverage 
behaviors, total caloric intake, and overall diet quality.  
o Secondary outcome measures are directly related to the iSIPsmarter’s underlying theoretical 
and conceptual framework. Acceptable psychometric properties have been established for our 
measures.2, 68-80  
 
 
 
BASELINE PROCEDURES (Health Assessment 1) 
• 
Telephone interview #1 completed by participant with a trained research assistant (at baseline 
only, this is completed with the first screening interview phone call and after the consent form is 
signed) 
o First 24-hour dietary recall 
o Self-reported height 
o Self-reported weight 
• 
On-line Questionnaire self-completed by participants  
o See table below and modules A-J of attachment  

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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o Mail welcome packet mailed to participant, including ©BodyTrace scale, after first telephone 
interview and on-line questionnaire is completed 
• Telephone interview #1 completed by participant with a trained research assistant  
o Second 24-hour dietary recall 
o Objective body weight using the cellular ©BodyTrace scale that is mailed to participants. 
Research staff will help troubleshoot ©BodyTrace scale procedures, including cellular 
connection. 
o Collect SSN for gift card issue purposes 
 
RANDOMIZATION 
Once participants sign the informed consent they are randomized into their assigned condition:  
o GROUP 1:  Sugary Drink Education Website 
o GROUP 2: iSIPsmarter Program Website  
Participants are notified of their randomized condition once their above baseline procedures 
are completed. 
 
INTERVENTIONS 
• Both websites (iSIPsmarter and Sugary Drink Education) will include the provision of 
evidence-based SSB behavioral content and the ability to track SSB and weight diaries 
(although iSIPsmarter groups will do this using online and SMS tools whereas the Sugary 
Drink Education site will provide printable documents). These features allow us to control 
for certain elements (e.g., self-monitoring through diaries), but it is necessary to balance 
issues of controlling for these constructs while still ensuring the ability to maximize web 
program differentiation and appropriately test our hypotheses. Although there is overlap 
between groups, iSIPsmarter will be a multi-component intervention that differs from 
standard patient education websites in the following ways: (1) Individually tailored SSB and 
weight recommendations based on user input; (2) High levels of interactivity to increase 
user engagement; (3) Structured implementation of the program through use of metered 
(distributed) content over the intervention period rather than content presented all at 
once; and (4) Provision of comprehensive user specific content rather than more general 
information. 
• Sugary Drink Education website will include scientifically accurate information that is 
typical of nutrition education websites and relevant content as adapted from our 
SIPsmartER intervention. The Sugary Drink Education website will include information about 
SSB recommendations, types of SSB and portion size, SSB-related health risks, energy 
balance information, identifying motivators and barriers to reducing SSB intake, interpreting 
SSB nutrition labels, and recognizing media influences and misclaims in SSB advertisements, 
as well as printable forms to track SSB and weight. Unlike iSIPsmarter, the content will not 
be tailored and will be presented all at once.  
o Time: There are no set time commitments, but participants are able to continue to 
review the website content as often as they would like over the course of the 18 
months.  

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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• iSIPsmarter is comprised of six Internet-based Cores and a recurring maintenance Core. 
Each Core includes behavioral content and personalized action planning pertaining to both 
SSB behaviors and weight, is personalized to the user, and provides follow-up and feedback. 
As such, iSIPsmarter is a highly interactive, structured, and self-guided program. Providing 
automated reminders to alert users when the cores are available is useful in promoting 
Core completion, and all users will receive up to two automated email reminders to 
complete the Cores.  
o iSIPsmarter Diaries 
 Related to SSB tracking, users are prompted daily to report their SSB 
intake (in ounces). For SSB prompts and diary entry, users can select 
between an online or SMS option.  
 Users will also be encouraged to weigh daily using their cellular enabled 
©BodyTrace. Weigh-ins from the ©BodyTrace scale are synced with 
iSIPsmarter allowing for personalized weight feedback when users log 
into the website.  If cellular connection does not work in the participants’ 
home, they will be allowed to enter their weight through the website. 
o Time:  
 During the 1st six weeks, the Internet Program will take approximately 1 – 
2 hours of the participant’s’ time each week.   
 After the 1st six weeks, there are no specified time requirements for use 
of the Internet program, but the participant is able to continue to review 
the program’s content over the course of the year.   
o Online task completion for iSIPsmarter is tagged and stored in our database, 
providing a standardized metric for determining and providing stepped care 
support. The timing of the delivery of stepped care will coincide with the timing 
of the six iSIPsmarter Cores. The decision to provide stepped care throughout all 
six Cores is driven by our previous SIPsmartER trials, where we observed 
fluctuations in user engagement and dropouts throughout the entire course of 
the intervention.52 Given that each iSIPsmarter Core is unlocked and available 7 
days after completion of the previous Core, these time points will be used as 
adherence check points. Operationally, the first time point occurs one week after 
the participant has been granted access to the program. Participants will be 
identified as either adherent or non-adherent with the automated email 
instructions to complete Core 1. If they have completed it, no additional support 
will be made and the participant will move on to the second intervention week 
(continue to receive the automated Core email prompts, as is standard for all 
iSIPsmarter Cores). If they have not completed the first Core, they will be 
identified as requiring stepped care and will receive Step 1-Text. This human-
supported text will include: (1) content stating that the user did not complete 
the Overview Core; (2) encouragement to log back in and complete the Core as 
soon as possible; and (3) support by asking if there were any concerns or 
obstacles to completing the assigned task for that week. Participants receiving 
this support would then be tagged as Step 1-Text. Their progress would be 

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technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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followed over the next week, and they would be re-evaluated at time 2. If they 
have completed the assignment by time 2, they would continue using the 
program. Yet, if they still did not complete the assignment, they would be 
stepped up to Step 2-Phone. When this occurs, the participant would be 
contacted by phone and again provided encouragement, technical assistance, 
and strategies to promote task completion. If this participant still does not 
complete the Core, they would be considered non-adherent. This process will 
continue for each participant at each of the six Core time points.  
• The process engagement variables, for specific aims 3, are automatically collected and 
stored in the database (e.g. number of logins, time/date of use, average session length, 
content viewed). SSB diaries and ©BodyTrace weight tracking are also captured within the 
iSIPsmarter database. Although participants in the Sugary Drink Education website 
condition may track SSB and weight diaries via printable forms, this data will not be entered 
or stored, nor will they have access to web-based ©BodyTrace data.  
 
FOLLOW-UP (Health Assessments 2-4) 
• Follow-up health assessments will occur at 9 weeks, 6 months, and 18 months. Participants 
will receive email and phone call reminders for each approaching follow-up health 
assessments. 
• Each of the follow-up health assessments will be the same as the first baseline health 
assessments and will include: an on-line questionnaire and 2 telephone interviews that 
include dietary recalls and weight. Variations to this are as follows: 
9 Week Follow-Up Assessment 
In addition, the on-line questionnaire the Internet Intervention Evaluation Measure81, 82 
and Internet Intervention Adherence Measure81, 83 will be administered at post (9-week) 
assessment to examine users’ experiences with and perceived efficacy of the programs. 
These measures are limited to the 9-week follow-up assessment.(SEE ATTACHMENT: 
15337 iSIP Outcome Assessment Packet_v1) 
6 Month Follow-Up Assessment 
o At the six month follow-up assessment the on-line questionnaire will include a four 
item Van Westendorp Price Sensitivity Meter to determine acceptability and 
feasibility of a future fee based intervention ( Van Westendorp P. H. (1976). NSS-
Price sensitivity meter: A new approach to study consumer perceptions of prices, 
ESOMAR (European Society for Opinion and Marketing Research) Congress, Venice, 
Italy. 139-167). There will also be an additional 6 items includes to access how 
participants accessed their assigned web-based programs and if they experienced 
any technical difficulties. These measures are limited to the 6-month follow up 
assessment. (SEE ATTACHMENT: 22130 NEW 6-MONTH QUALTRICS QUESTIONS 
AMENDMENT 3.25.22)  
o At the six month follow-up assessment a brief summative interview will be 
conducted during the first dietary recall to obtain feedback on decision making 
processes for consenting or declining the optional Biobank Study (IRB# 210186) 
linked to the current iSIPsmarter study. Questions are designed to solicit information 

IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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about their experience with iSIPsmarter and the Biobank and to help provide insight 
into future recruitment of  rural populations into Biobank studies. Responses will be 
summarized via interviewer notes. (SEE ATTACHMENT: 22130 BIOBANK 
SUMMATIVE EVALUATION FOR CONSENTED PARTICIPANTS 3.25.22 and 22130 
BIOBANK SUMMATIVE EVALUATION FOR DECLINED PARTICIPANTS 3.25.22 ) 
 
Please note that variations to the online survey and phone interviews fall within the original 
consent form time and description parameters. Time estimates to complete assessments at 9 
weeks and 6 months continue to fall within 90 minutes and additional questions refer to 
feedback and satisfaction regarding their experience in the study. (SEE ATTACHMENT: 22130 
ASSESSMENT MEASURES AND TIME COMPLETION ESTIMATES ACROSS THE ISIPSMARTER 
PROJECT 3.25.22) 
 
Participants can continue using their online program between each follow-up assessment until 
the 18-month follow-up.  After the 18-month follow-up: 
• Participants can have the option of continuing to use their assigned website until the 
end of grant funding.   
• Or they have the option of using the other version of the website that they did not use 
during the trial. 
 
 
2. If this protocol involves study treatment, explain how a subject will be transitioned from 
study treatment when they have completed their participation in the study.   
Example:  If the subject will be taking an investigational drug, will they need to be put 
back on an approved drug when they have completed the study?  If yes, explain how 
this will be accomplished and who will cover the cost.  If the subject has a device 
implanted will it be removed?  Again- who will cover the cost of the removal?   
Instructions: Answer NA if this study does not involve a study treatment.   
Answer/Response:  
 
Once the behavioral interventions have ended, the participants will resume their usual medical 
care, at their own cost. 
Bibliography 
INSTRUCTIONS:  Provide a current bibliography supporting the hypothesis, background and 
methodology including references to papers and abstracts that have resulted from previous 
work by the investigator and references to the work of others. 
 
References 
 
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IRB-HSR #22130: iSIPsmarter: An RCT to evaluate the efficacy, reach, and engagement of a 
technology-based behavioral and health literacy intervention to reduce sugary beverages among 
rural Appalachian adults 
 
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rural Appalachian adults 
 
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APPENDIX:  Non- UVa Personnel 
 
1. Explain the duties of non-UVA personnel on this protocol.  
• Undergraduate/Graduate Volunteers: These include students studying in the Human 
Nutrition, Food, and Exercise Department and MPH program at Virginia Tech 
University.  Current students include: Jayme Price (undergraduate), Baily Steele (MPH 
Student). All students have completed UVA CITI Human Subjects training. 
2.  Explain your plans for training and oversight of these personnel.  
 
Students will be supervised by the study coordinator, Donna Brock, and trained by 
appropriate research team members on data entry, procedural tracking, dissemination of 
study materials, and recruitment processes as necessary. 
 
3.  How do you plan to access any study records the non-UVA personnel might maintain?  
All data will be maintained on-site by UVA personnel.   
 
4.  Will the non- UVA personnel be exposed to any additional risk while working on this 
protocol?   
 No. 
 
5.  List name of any other institution with which they have an affiliation.   
  Non-UVa study team members have affiliations listed above.  
 
6.  Will the non- UVa personnel have access to UVa patients or their health information along 
with any HIPAA identifiers prior to consent?   
These are not UVA patients.  However, the volunteer students will have access to 
participant contact information for the purpose of disseminating study materials via FedEx 
mailings. 
 
 
YES 
NO 
 
X 
 
1.  Name 
X 
 
2.  All geographic subdivisions smaller than a state, including street 
address, city, county, precinct, zip code, and their equivalent geocodes, 
except for the initial three digits of the zip code if, according to the 
current publicly available data from the Bureau of the Census: (1) The 
geographic unit formed by combining all zip codes with the same 3 initial 
digits contains more than 20,000 people and (2) The initial 3 digits of a zip 
code for all such geographic units containing 20,000 is changed to 000.  
 
X 
3.  All elements of dates (except year) for dates directly related to an 
individual, including birth date, admission date, discharge date, date of 
death; and all ages over 89 and all elements of dates (including year) 

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indicative of such age, except that such ages and elements may be 
aggregated into a single category of age 90 or older.  
[This means you may record the year but not record the month or day of 
any date related to the subject if the subject is under the age of 89.  In 
addition if the subject is over the age of 89 you may not record their age 
and  you may not record the month, day or year of any  date related to the 
subject ] 
X 
 
4.  Telephone numbers 
 
X 
5.  Fax numbers 
 
X 
6.  Electronic mail addresses 
 
X 
7.  Social Security number 
 
X 
8.  Medical Record number 
 
X 
9.  Health plan beneficiary numbers 
 
X 
10.  Account numbers 
 
X 
11.  Certificate/license numbers 
 
X 
12.  Vehicle identifiers and serial numbers, including license plate 
numbers 
 
X 
13.  Device identifiers and serial numbers 
 
X 
14.  Web Universal Resource Locators (URLs) 
 
X 
15.  Internet Protocol (IP) address numbers 
 
X 
16.  Biometric identifiers, including finger and voice prints 
 
X 
17.  Full face photographic images and any comparable images  
 
X 
18. Any other unique identifying number, characteristic, code that is 
derived from or related to information about the individual (e.g. 
initials, last 4 digits of Social Security #, mother’s maiden name, first 3 
letters of last name.) 
 
X 
19. Any other information that could be used alone or in combination 
with other information to identify an individual. (e.g. rare disease, 
study team or company has access to the health information and a 
HIPAA identifier or the key to the code . ) 
 
7.  If any items above are checked YES, list names of non- UVa affiliated individuals who will 
have access.  
 
Bailey Steele, student volunteer (Virginia Tech MPH program) 
Jayme Price, student volunteer (Virginia Tech, undergraduate in HNFE program)