Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers: A RCT
Phase: NA
Conditions: Obesity, Childhood, Physical Activity, Nutrition
Sponsor: Seattle Children's Hospital

 
Principal Researcher: Jason Mendoza, MD, MPH 
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Title: Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers 
 
NCT Number: NCT03575884 
 
Document Date: 04/19/2024 
 
 

 
Principal Researcher: Jason Mendoza, MD, MPH 
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Protocol Version Date: 4/19/2024 
 
 
 
 
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PROTOCOL TITLE:  
 
Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers: A randomized controlled trial 
 
PRINCIPAL INVESTIGATOR: 
Jason Mendoza, MD, MPH 
Center for Child Health, Behavior and Development 
206-884-1261 
jason.mendoza@seattlechildrens.org 
 
• 
Table of Contents 
1.0 
Objectives ............................................................................................................................ 4 
2.0 
Background .......................................................................................................................... 4 
3.0 
Inclusion and Exclusion Criteria .......................................................................................... 6 
4.0 
Study-Wide Number of Subjects ......................................................................................... 6 
5.0 
Study-Wide Recruitment Methods ...................................................................................... 6 
6.0 
Multi-Site Research ............................................................................................................. 7 
7.0 
Study Timelines ................................................................................................................... 8 
8.0 
Study Endpoints ................................................................................................................... 8 
9.0 
Procedures Involved............................................................................................................. 8 
10.0 Data and Specimen Banking .............................................................................................. 17 
11.0 Data Analysis/Management ............................................................................................... 17 
12.0 Confidentiality ................................................................................................................... 18 
13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects ...................................... 19 
14.0 Withdrawal of Subjects ...................................................................................................... 20 
15.0 Risks to Subjects ................................................................................................................ 20 
16.0 Potential Benefits to Subjects ............................................................................................ 21 
17.0 Vulnerable Populations ...................................................................................................... 21 
18.0 Community-Based Participatory Research ........................................................................ 21 
19.0 Sharing of Results with Subjects ....................................................................................... 21 
20.0 Setting ................................................................................................................................ 21 
21.0 Resources Available........................................................................................................... 22 
22.0 Prior Approvals .................................................................................................................. 23 
23.0 Recruitment Methods ......................................................................................................... 23 
24.0 Use of Social Media ........................................................................................................... 23 
25.0 Local Number of Subjects ................................................................................................. 24 
26.0 Provisions to Protect the Privacy Interests of Subjects ...................................................... 24 
27.0 Compensation for Research-Related Injury ....................................................................... 24 
28.0 Economic Burden to Subjects ............................................................................................ 24 
29.0 Consent Process ................................................................................................................. 24 
30.0 Process to Document Consent in Writing .......................................................................... 28 
31.0 Drugs or Devices................................................................................................................ 29 

 
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32.0 Good Clinical Practice ....................................................................................................... 29 
 

 
Principal Researcher: Jason Mendoza, MD, MPH 
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1.0 
Objectives  
This randomized controlled trial will be conducted in Seattle under the supervision of Dr. Jason Mendoza and 
Seattle Children’s IRB, Yakima Central Valley under Dr. Rachel Ceballos and the IRB at Fred Hutchinson 
Cancer Research Center, and in Houston under Dr. Teresia O’Connor and the IRB at Baylor College of 
Medicine. 
 
Calendar year 
 
2019 
2020 
2021 
2022 
2023 
Quarter 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Wave 1 (S) 
 
 
 
 
 
Wave 2 (S, CV, H) 
 
 
 
 
 
Wave 3 (S, CV, H) 
 
 
 
 
 
Wave 4 (S, CV, H) 
 
 
 
 
 
Analyses 
 
 
 
 
 
Dissemination, 
Papers 
 
 
 
 
 
1.1 Specific Aims: 
1. 
To conduct a cluster RCT of the Fit 5 Kids curriculum to evaluate its 
efficacy in reducing screen time and excessive weight gain over a school year (8 
months)  
2. 
To examine mediators and moderators associated with reducing Latino 
preschoolers’ screen time 
1.2 Hypotheses: 
1. 
Fit 5 Kids will decrease children’s screen time (primary outcome), BMI z-
scores and dietary energy intake, and increase moderate to vigorous physical 
activity (MVPA) compared to controls 
2. 
Parents’ outcome expectations, self-efficacy, and screen time parenting 
practices will mediate the relationship between Fit 5 Kids and changes to 
preschoolers’ screen time 
3. 
Parents’ depressive symptoms, stress, and social support will moderate 
changes to child screen time 
2.0 
Background 
2.1 Gaps in Current Knowledge: Childhood obesity is a major public health problem in the 
US. Childhood obesity and lack of physical activity (PA) are important risk factors for adult 
obesity, type 2 diabetes, cardiovascular disease, and multiple cancers. Since childhood 
PA, obesity and cardiometabolic risk track strongly into adulthood, childhood obesity 
prevention is necessary to reduce the lifetime risk of obesity and related chronic diseases. 
Due to childhood obesity inequities, interventions for PA promotion and obesity prevention 
are urgently needed for populations most affected by obesity. Latino children have among 
the highest rates of obesity, and are the largest and fastest growing minority in the US. 
Therefore, preventing childhood obesity among Latinos is a major US public health goal to 
reduce health inequities from obesity and risk of T2D in the US. However, a systematic 
Key:  
S=Seattle 
CV =Central 
Valley H=Houston 

 
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review identified no successful obesity prevention interventions among Latino 
preschoolers. 
2.2 Preliminary Data: Studies by our group and others inform the scientific premise of this 
study and have linked higher screen time among preschoolers with elevated risk of 
obesity. Television viewing and other forms of screen time (henceforth called screen time) 
occupy a large part of children’s awake time. Intervention studies that reduced screen time 
among older children have resulted in reductions to obesity, although there are few studies 
among preschoolers. While mechanisms linking screen time and excessive weight gain 
remain unclear it is thought that screen time leads to excessive dietary intake and/or 
inadequate PA. Among Latino preschoolers, we reported that greater screen time was 
associated with less PA, suggesting that reducing screen time may increase PA. Because 
screen time behaviors track from preschool to adolescence, the preschool years are a 
crucial time period to help children develop long term healthy screen time behaviors.   
Our team’s pilot study tested the culturally adapted Fit 5 Kids screen time reduction 
curriculum among Latino preschoolers in Head Start. This short term cluster randomized 
controlled trial (RCT) is the only successful screen time reduction program for Latino 
preschoolers, which reduced screen time by >25 min/day. Fit 5 Kids seeks to teach 
preschoolers to decrease their screen time and encourage alternative activities such as 
family meals, reading, and active playtime. These efforts were accompanied by substantial 
formative work to validate a measure of screen time and to identify correlates of obesity for 
Latino preschoolers. Building on this previous work, we propose a long term, efficacy 
cluster RCT of high scientific rigor to test the culturally adapted Fit 5 Kids among Latino 
preschoolers in Head Start from three sites: Seattle, Houston, and the Central Valley of 
Washington State. 
2.3 Significance: Childhood obesity and lack of PA in the US are at record high levels, which 
elevates risk of multiple childhood diseases as well as the risk of adult obesity and thus 
T2D, CVD, and multiple types of cancers. Screen time is an important modifiable 
determinant of childhood obesity and PA. This study’s scientific premise has been 
established by multiple studies on screen time and risk of obesity, as well as the lack of 
successful screen time intervention studies among Latino preschoolers. First, Latino 
children in the US have both high rates of screen time and obesity. RCTs whose 
interventions solely focused on reducing screen time have reported:  
(1) reductions in BMI and other measures of obesity among older school-age children 
(school-based obesity prevention intervention), and  
(2) significant reductions in BMI z-score among 4-7 year old children who started at or 
above the 75th BMI percentile.  
Similar obesity prevention interventions for screen time are lacking among Latino 
preschoolers.  
Because habitual screen time behaviors become established during the preschool years, 
interventions are needed to help reduce screen time among Latino preschoolers. For 
example, we have shown that higher screen time was significantly associated with less PA 
among Latino preschoolers in Head Start, this proposal’s target population. Moreover, 

 
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children’s PA typically declined with age such that when children entered adolescence, 
few met the recommended 1-hour of daily MVPA regardless of race/ethnicity; conversely, 
screen time increased by over 3 hours/day from childhood into adolescence, with Latino 
adolescents having the highest amounts of screen time. 
3.0 
Inclusion and Exclusion Criteria 
3.1 Parents of students at 22 Head Start Centers will be sent home with study information.  
Should the decide to participate, they will be screened using a survey to check for 
eligibility criteria listed below.   
3.2 Inclusion Criteria:   
We will recruit Latino children, 3-5 years old enrolled from 22 Head Start Centers. 
Their parents must read and speak English or Spanish or both. 
Exclusion Criteria:  
Only one preschooler per family may be enrolled to avoid clustering of variables by 
family. 
3.3 Special Populations: 
1. 
Individuals who are not yet adults (infants, children, teenagers).  We will enroll 
children and their parent(s) in the study. We will enroll 3-5 year old children, who do 
not have the developmental capacity to make an informed decision with regard to 
participating in this study.  Obtaining informed assent in children this young may 
possibly be coercive, since children of this age are highly suggestible to adults. 
 
4.0 
Study-Wide Number of Subjects 
4.1 We will enroll 280 parent/child dyads in the study across all sites. 
5.0 
Study-Wide Recruitment Methods 
5.1 When, where, and how potential subjects will be recruited: 
We will use recruiting strategies that have previously been highly successful for the 
investigators during studies conducted in Head Start centers over the past 10-15 years. 
We will recruit participants from Head Start centers that serve substantial numbers of 
Latino families and use a combination of recruitment procedures including: 
• 
bilingual flyers sent home with the children 
• 
telephone calls (contact information to be collected when consent is returned) 
• 
presentations at parent meetings (specific presentation content under 
development), and  
• 
active involvement/guidance of the Head Start manager and staff in the recruitment 
process. 
 

 
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5.2 Methods that will be used to identify potential subjects: 
We will send home recruitment packets with all students in the participating Head Start 
program.  Families that wish to participate and match the inclusion criteria will return the 
consent form to the study staff or complete an online form with their contact information. 
5.3 Materials that will be used to recruit subjects: 
Students at the Head Start Schools will be sent home with the bilingual flyers and consent 
forms or they will be provided links to view the flyers, recruitment video, and consent forms 
electronically.  Flyers and consent forms will also be handed out at parent meeting 
presentations. Extra copies of the materials will be on hand with each on-site Head Start 
manager. 
 
To keep families in the intervention study engaged across three assessments throughout a 
period of 8 months, parents will receive a $20 incentive at Time 1 (Sept/Oct), $25 at Time 
2 (Jan), and $35 at Time 3 (May/June). For wearing accelerometers, participants will 
receive an additional $10 incentive at each of the three assessments. For the 40 adults 
who participate in qualitative interviews, they will receive an additional $20 incentive. At 
the beginning of the school year, we will provide head start centers $400. Then, we will 
provide $500 per center incentive near the end of the school year.  
6.0 
Multi-Site Research 
Conference calls will be held no less than once-a-month and will include each site investigator, coordinator, 
and other relevant stakeholders depending on the phase of the study. For example, during the initial planning 
phase individuals involved in curriculum development and training are likely to be more involved, while the 
coordinators and other primary staff may be included in calls during the intervention. In addition, we will 
designate a secure virtual site for sharing of current protocols and documents. 
6.1 In order to ensure communication and uniformity between sites: 
1. 
All sites will have the most current version of the protocol and consent document. 
2. 
All required approvals will be obtained at each site (including approval by the site’s 
IRB of record). 
3. 
All modifications will be communicated to sites, and approved (including approval by 
the site’s IRB of record) before the modification is implemented. 
4. 
All engaged participating sites will safeguard data as required by local information 
security policies. 
5. 
All local site investigators will conduct the study appropriately. 
6. 
All non-compliance with the study protocol or applicable requirements will be 
reported in accordance with local policy. 
6.2 Methods for communicating to engaged participating sites: 
1. 
Problems: Should any problems arise,  
2. 
Interim results 
3. 
The closure of a study 

 
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7.0 
Study Timelines 
7.1 Participants enrolled in the study will participate for the duration of the school year 
(approximately 8 months).  
7.2 We expect to enroll participants in 4 waves.  All participants will be enrolled by end of 
calendar year, 2021.  The final wave of participants will finish in June of 2022.  
7.3 We expect analysis to be completed by end of calendar year, 2023.   
8.0 
Study Endpoints 
8.1 Participant involvement in the study will be complete by June, 2022.  We expect 
preliminary analysis to be completed by end of calendar year, 2023. 
8.2 Participant safety monitoring will be complete with the end of participant involvement in 
June, 2022. 
9.0 
Procedures Involved 
9.1 
Study design: The implementation of the intervention will be accomplished in four 
separate waves of intervention and control centers. In year 1, Dr. Mendoza will enroll two Head 
Start centers in the Seattle-metro area for assessments and to be randomly assigned to the 
intervention or control condition. In each of years 2-4, Drs. Mendoza, Ceballos, and O’Connor 
will each enroll two Head Start centers in their respective regions for assessments and 
randomization to the intervention or control condition.  
The intervention schools will integrate the culturally adapted Fit 5 Kids curriculum into their 
standard preschool day, which may be in person or remote based on how the school educating 
their students and how they recommend fitting the curriculum into their program.  Research staff 
members will be trained as interventionists to teach Fit 5 Kids by Sandra Jaramillo, the 
interventionist from the pilot Fit 5 Kids RCT (consultant, see letter of support). The 
interventionists may implement the curriculum at the head start center or develop videos for 
parents to share with their students. Interventionists will undergo the teacher training program 
developed by Dr. Mendoza and Sandra Jaramillo for the pilot Fit5Kids study. Training will 
consist of:  
1. 1-week in person training led by Sandra Jaramillo and Dr. Mendoza and 
2. Ongoing supervision of the interventionists by Ms. Jaramillo and Dr. Mendoza. 
The in person training will occur prior to each region’s implementation of the Fit 5 Kids 
curriculum, i.e., for the Seattle-based interventionist at the beginning of year 1 and for the 
Central Valley and Houston-based interventionists at the beginning of year 2. The in person 
training will provide: an overview of the Fit 5 Kids curriculum, discussion of the implementation 
of lessons, observation of selected lessons as taught by Ms. Jaramillo, and practice teaching 
opportunities of selected lessons by interventionists with feedback from Ms. Jaramillo and Dr. 
Mendoza. Key portions of these trainings will be video-recorded (staff only) and available for 
review by the interventionists throughout the study. Following the in person training, Ms. 
Jaramillo, Dr. Mendoza, and the co-investigators, will hold joint monthly 
videoconferences/telephone meetings with the interventionists, to support their teaching efforts 

 
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and answer any questions that may arise. Ms. Jaramillo, Dr. Mendoza, and the co-investigators 
will also be available to the interventionists by email or telephone call should the need arise.  
The culturally adapted Fit 5 Kids classroom curriculum will be taught by trained research staff 
interventionists at each of the three study sites. Fit 5 Kids is taught over 7-8 weeks and consists 
of 7 weekly themes, which are  
1. Increase reading,  
2. Increase the time families eat meals together with the screens turned off,  
3. Alternatives to screen time, 
4. Too much screen time,  
5. Turn off the screens week,  
6. Celebrate, and  
7. No more couch potatoes.  
Each weekly theme is comprised of 5-6 lesson plans organized around each theme. The lesson 
plans include group activities as well as activities for home, which may be physically sent home 
with students or digitally sent to parents. The lessons are drawn from four educational 
disciplines:  
1. Language Arts 
2. Math 
3. Music and Movement, and 
4. Arts and Crafts.  
Fit 5 Kids also includes a substantial parent component, including:  
1. A weekly parent newsletter to keep them informed of the lessons and to provide home 
activities for the parents to complete with their preschoolers during the 7-8 week 
curriculum. The parent newsletter activities were adapted based on our previous work on 
parent self-efficacy and parent outcome expectations for limiting their preschoolers 
screen time as well as screen time parenting practices. Thus, these constructs will be 
tested as mediators of the relationship between the Fit 5 Kids intervention and changes 
to screen time. For parents of limited Spanish or English literacy, the take home 
materials will also be summarized verbally to them when they pick up their children from 
the Head Start center. 
2. Twice monthly intercepts of parents during child drop off/pick up times for brief, child-
tailored goal setting around screen time reduction strategies led by study staff. If parents 
are not available, we will contact them by telephone for goal setting.  
3. A lending library of age-appropriate English and Spanish books (including the 
LeapReader Reading & Writing System), games (e.g., puzzles, Lego Duplo blocks, 
Magna-Tiles, Playmobile, Bristle Blocks, etc.), arts/crafts, and other projects that children 
can do alone or with their parents. The library resources will be available for loan 

 
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throughout the entire school year and developed with input from Head Start teachers 
and parents at each of the three major sites.  
4. Brief text messages consisting of screen time parenting practices from the Fit 5 Kids 
parent newsletters and/or associated with lower child screen times. A new text message 
will be delivered 2-3X/week to the parents’ cell phone (or email) over the 7-8 weeks of 
the curriculum and during the booster weeks (see below). Dr. Mendoza has experience 
delivering brief text messages to study participants in other PA/sedentary behavior 
intervention studies both ongoing (NCT02469727 and NCT02031185) and completed. 
The parent newsletters, goal setting, library resources, and text messages seek to 
increase parenting behaviors and behavioral constructs to limit their preschoolers’ 
screen time, in synergy with the classroom curriculum which focuses on empowering 
preschoolers to limit their screen time. 
5. Parents will also be invited to join an optional Facebook group that is private and only 
accessible to other study participants and members of the study team. Group members 
will be encouraged to share ideas related to the weekly lessons and goal setting. They 
are also encouraged to share any experiences and provide support to other parents 
around making changes related to the study and reducing screen time in their home. 
Intervention booster weeks: Fit 5 Kids takes 7-8 weeks to fully teach. Given that we are 
interested in producing longer term behavior changes to preschoolers’ screen time, we plan 
to add two “booster” weeks of the curriculum in late April/early May that will be delivered by 
each site’s staff interventionist. Similar to the main Fit 5 Kids curriculum, the booster weeks 
will also have a take-home parent newsletter although on a daily basis (not weekly), goal 
setting with parents by phone or in person during child pick ups/drop offs, as well as daily 
text messages consisting of parenting tips on screen time reduction. The two booster weeks 
will mainly focus on the “Alternatives to screen time” and “Turn off the screens” lessons. 
Additionally, parents will be highly encouraged to borrow resources from the lending library 
that helps to achieve their children’s goals. 
Remote Intervention Delivery: In case it is not feasible to implement the Fit 5 Kids program 
as described above, which was originally designed for in person curriculum delivery, we will 
plan to implement remote intervention delivery. 
1. Curriculum Video Lessons – Each lesson in the Fit 5 Kids curriculum will have a 
corresponding video lesson, which will be posted to a Fit 5 Kids YouTube channel, 
and parents will be sent links to watch the videos. These videos will be posted as 
“unlisted” so that only people with the link may view them. 
2. Activity Material Mailings – For each week of the curriculum we will mail home 
materials for one activity from a lesson that week so that parents can guide their 
child through the activity at home. 
3. Digital Lives – These are optional, as the Facebook group is. During each week of 
the curriculum we will offer parent and child participants the option of attending a 
digital live stream where we will describe the topic of each curriculum week, discuss 
content from the parent newsletters, and demonstrate how to do the activity we mail 
home to them. These will be organized by the study team and done via a YouTube 

 
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Live Stream, which will be set as “unlisted” so that only people with the link to the live 
stream will be able to join. Parent participants will be invited to join the live stream, 
which will be led by study staff. 
4. Parent Newsletters – We will have a version of the newsletter that matches more 
with remote intervention delivery. A paper copy of each week’s newsletter will be 
mailed alongside the activity materials being mailed home. A digital version of each 
week’s newsletter will also be made available.  
5. Books & Activities Catalog – In place of a Lending Library system, we will use a Book 
& Activities Catalog (similar to Lending Library Catalog), which will be mailed home 
with the first weeks of activity materials with a return envelope that parents can use 
to mail it back to us with their selections. The catalog will also be available digitally. 
Instead of borrowing items for a short time, participants will get to select a few items 
that we will mail to them to keep. 
6. Text Messages for Screen Time Parenting Practices – These will generally be 
implemented in the same way, but a few text messages have been updated to make 
more sense with remote intervention delivery. 
7. Goal Setting – Similar process, except we will rely more on telephone or text 
communication to complete goal setting. We will also aim to do goal setting weekly 
vs twice monthly to gauge engagement in the remote intervention. 
8. Facebook – Similar process. However, we will further utilize Facebook as a platform 
to distribute video lessons to participants, post the newsletters, post pictures of the 
activities being mailed home, share information for attending the digital lives, and 
post the parent engagement questions from the goal setting form as another way to 
gauge their engagement in the remote intervention. This content will also be 
available to participants outside of Facebook.  
9. Booster Weeks – If booster weeks are done remotely, we will follow similar 
procedures as outlined above. Like the in-person version of the booster weeks, 
parents will still receive a newsletter and text message tip daily (for each lesson). 
There will be 5 video booster lessons, and we will mail home activities for 4/5 of 
them. Parents will be invited to attend an optional Digital Live. We will set goals once 
for the booster week(s) period, and will still post the same type of content on 
Facebook.   
Control condition: The control centers will not implement Fit 5 Kids but will instead provide 
their children with the standard Head Start preschool curriculum. This standard curriculum 
typically provides brief advice on healthy eating and active living, but does not go into detail 
about screen time reduction.  As this is the standard practice of Head Start programs, there 
are no ethical issues to consider with the control participants.    
Measurement Procedures.  The investigators have experience with all proposed questionnaires and 
accelerometry among Latino families, ensuring high scientific rigor. All assessments and surveys 
measuring mediating, moderating and outcome variables as well as covariates will be assessed 
immediately pre-intervention (Time 1, i.e., September/October of each year), immediately after the 
classroom intervention (Time 2, i.e., January of each year), and 8-months after starting the 

 
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intervention (Time 3, i.e., May/June of each year). The Time 2 measurement is necessary in order 
to detect changes in mediators (e.g., parenting practices and parent self-efficacy) that will be 
expected to change prior to outcomes such as BMI z-score. The Time 2 measurement will allow for 
mediation analyses to better describe mechanisms underlying changes in outcomes.98 The dietary 
assessment by Food Frequency Screener will occur at Time 1, Time 2, and Time 3. Research staff 
will collect socio-demographic and anthropometric measurements on the children and parents at 
their assigned Head Start center.  
 
Table 1. Summary of study variables 
 
 
10. Primary outcome: Screen time.  We will measure screen time using the screen time diary 
that Dr. Mendoza previously validated among parents of Latino preschoolers in Head Start (see 
Preliminary Studies) and used in the pilot RCT of Fit 5 Kids.40,41 The diaries will track the preschool 
children’s screen time for a 7-day period and are divided into 15-minute blocks between 6 am and 
12 am. For each block, the parent will be asked to indicate whether the study child had screen time, 
the type of device (television, computer, phone, tablet, etc.), the name of the program, the language 
of the program, and who if anyone was co-viewing with the child.  These diaries will be available in 
English and Spanish for the parents to fill out according to their language preference. For parents of 
limited written literacy, the screen time diaries will only require them to mark a box next to the time 
their child had screen time. 
 
11. Mediating variables: Self efficacy and outcome expectations. Social Cognitive Theory118,119 
is the most commonly applied behavioral theory for school-based childhood obesity studies120 and 
for PA studies targeting Latino girls and women.121 Given this long and successful track record, 
social cognitive theory was chosen to inform the design and evaluation of this behavioral 
intervention at the individual-level.122 The social cognitive theory constructs of self-efficacy, i.e. 
one’s personal sense of control for a behavior, and outcome expectations, i.e. the expected 
outcomes (costs/benefits) of performing the health behavior, have been well studied and have 
strong support for their role in children’s PA behaviors.120,121,123 We will use questionnaires that our 
team has developed and validated (see Preliminary Studies above) among Latino families on 
parent self-efficacy (14 items) and outcome expectations (25-items) for their preschoolers’ 
screen time usage as mediators of the relationship between the intervention and changes to screen 
time.69,70 
 
12. Mediating variable: Screen time (media) parenting practices. The screen time parenting 
practices scale, also called the TV Parenting Practices scale, consists of 15-items with the following 
responses: never, rarely, sometimes, or often.66 Our team has validated these questions among 
Latino families, including preschool age children. Screen time parenting practices will be a mediator 
for the relationship between the intervention and changes to screen time.67 
 
13. Anthropometric outcome: BMI z-score.  Study staff will measure height and weight per 
standard NHANES protocol.124 A portable stadiometer will be used to measure height (to nearest 
0.1 cm), and an electronic scale to measure weight (to nearest 0.1 kg). Duplicate measures will be 
taken with the mean recorded as the value. A third measurement will be taken if there is >0.2 cm or 
0.2 kg difference; the two closest values will be used to calculate the mean value. BMI (kg/m2) will 
be calculated and BMI z-scores will be determined based on 2000 CDC growth charts99 as per the 
Expert Committee Recommendations for assessment of overweight and obesity among 2-19 year 
olds.125  

 
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14. Behavioral outcome: Dietary intake by Food Frequency Screener.  The preschool 
children’s usual dietary intake over the past 6 months will be measured by the Block Kids Food 
Frequency Screener as reported by their parents, and screener data will be processed by 
NutritionQuest (Berkeley, CA), an international leader in dietary assessment and analysis. The 
Block Kids FFQ, available in English and Spanish, has been validated compared to 24-hour dietary 
recalls among children, and yielded significant correlations for energy intake (r=0.43), % energy 
from fat (r=0.51), % energy from carbohydrates (r=0.69), % energy from protein (r=0.55), dairy 
servings (r=0.74), and fruit servings (r=0.52).55 The Block Kids FFQ estimates of fruit and 
vegetables significantly correlated with the objective biomarkers of children’s serum carotenoids 
and skin carotenoids.56,102 Total dietary energy intake will be a behavioral outcome of interest. Dr. 
Mendoza has led and/or substantially contributed to multiple nutritional epidemiological studies 
among children.85,126-133  
15. Exploratory behavioral outcomes: fruit and vegetable intake and skin carotenoids. 
Several recent reviews have summarized emerging evidence linking greater screen time/television 
viewing with lower intake of fruits and vegetables,134,135 including in preschool-age children.136 While 
most of the evidence is observational, intervention studies focused on reducing screen time are well 
situated to explore this potential causal inverse relationship between screen time and fruit and 
vegetable intake. Because greater fruit and vegetable intake is associated with lower risk of several 
chronic diseases,137,138 and increasing fruit and vegetable intake is a goal of Healthy People 2020,53 
examining whether screen time affects fruit and vegetable intake is important to inform prevention 
interventions and policies. Thus, we will examine fruit and vegetable intake from the Block Food 
Frequency Screener as an exploratory behavioral outcome of interest. 
Skin carotenoids are an objective biomarker of fruit and vegetable intake in children and 
adults, and are responsive to changes in carotenoid intake from fruits and vegetables.100 Skin 
carotenoids have been validated against plasma concentrations of carotenoids as reviewed,100,139 
Dietary intake of carotenoids as estimated by the Block Kids FFQ was significantly correlated 
(beta=0.87, p=0.02) with skin carotenoids among a diverse sample of children (59.8% Latino, 
25.7% Black).102 Similarly, dietary intake of total fruit (r=0.21), total vegetables (r=0.32), and total 
carotenoids (r=0.40) estimated by the Block Kids FFQ among preschoolers was significantly 
(p<0.05) correlated with skin carotenoids.56 Skin carotenoids measurements are taken on the palm 
of participants’ hands, where skin melanin is found at their lowest concentrations and do not bias 
results.101,102 We will use the commercially available instrument, “BioPhotonic Scanner” (Pharmanex 
Global Research, Provo, UT), which was used in a previous pediatric validation study.56 Two 
instruments will be provided free of charge by Pharmanex (see letter of support by Dr. Steve 
Wood), along with training and technical support. The Seattle and Central Valley sites in 
Washington State will share one instrument while the Houston site will use the other to measure 
preschoolers’ skin carotenoids per a standard protocol at Times 1, 2, and 3. Measurements will also 
be compared to fruit and vegetable intake estimated by the Block Kids Food Frequency Screener, 
as further validation of the Food Frequency Screener among Latino preschoolers. Skin carotenoids 
will be an exploratory objective outcome for the present study, similar to fruit and vegetable intake 
via the Block Food Frequency Screener. 
Table 1. Summary of study variables 
Variable 
Instrument 
Variable type 
Validation and other 
study references 
Investigators with 
expertise 
Screen time 
Screen time diary (7-day) 
1o outcome 
40,41,54 
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Model of Goal Directed 
Behavior 
Attitudes (15-item) 
Perceived 
Positive/Negative 
Behavioral Control (17-
item) 
Subjective Norms (9-item) 
Positive and Negative 
Anticipated Emotions (29-
item) 
Habits (9-item) 
Self-efficacy (14-item) 
Desires (7-item) 
Intentions (10-item) 
Mediator 
40 
Mendoza 
Parent outcome 
expectations for limiting 
screen time 
POETV (25-item) 
Mediator 
68-70 
O’Connor, Hughes 
Screen time parenting 
practices 
Screen time parenting 
practices (15 items) 
Mediator 
66,67 
Mendoza, O’Connor, 
Hughes 
BMI z-score 
Measured height & weight 
Anthropometric 
outcome 
99 
All 
Dietary energy intake (for 
the past 6 months) 
Block Kids Food Frequency 
Screener (40-items) 
Behavioral 
outcome 
55 
Mendoza, O’Connor, 
Hughes 
Skin carotenoids  
Resonance Raman 
Spectroscopy  
Exploratory 
outcome 
56,100-102 
Pharmanex (see LOS) 
PA and sedentary behavior 
time 
Actigraph accelerometer 
GT3X+ 
Behavioral 
outcome 
33,40-42,57,103-110 
Mendoza, O’Connor, 
Hughes 
Maternal depressive 
symptoms 
CES-D (20-item) 
Moderator 
71-73,111,112 
Hughes 
Maternal social support 
Multidimensional Scale of 
Perceived Social Support 
(12-item) 
Moderator 
74,75,113 
Hughes 
Maternal stress 
Cohen’s Perceived Stress 
Scale (14-item) 
Moderator 
71,74-76,113 
Hughes 
Demographics 
Socio-demographic survey 
Covariates 
33,40-42,57,103-110 
All 
Parent perceptions of 
neighborhood safety 
Neighborhood disorder 
scale (8-item) 
Covariate 
40-42,114,115 
Mendoza, O’Connor 
Acculturation 
Bidimensional Acculturation 
Scale for Hispanics (24-
item) 
Covariate 
116,117 
All 
COVID-19 Questionnaire 
Behavioral Insights, 
Household Pulse, 
Resilience 
Covariate 
 
WHO, U.S. Census 
Bureau 
 
 
 
16. Behavioral Outcome: Physical activity and sedentary behavior time via accelerometry. PA 
will be objectively measured by the ActiGraph GT3X+ worn on a belt at the hip (Actigraph LLC, 
Pensacola, FL). It provides an objective measure of duration, frequency and intensity of movement over 
time and steps taken, thereby providing a valid and objective measure of PA in children.48,58 These 
accelerometers will collect data at a raw data sample frequency of 30 Hz and later processed into 15-
second epochs.58 Preschool participants will wear the accelerometers over 7-day periods each at 
Times 1, 2, and 3.58 Dr. Mendoza has used accelerometer protocols and/or analyzed data for previous 
and ongoing studies involving low-income and minority participants from preschool- to young adult-

 
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age.41,42,103,104,140,141 Accelerometers will be delivered to and picked up from participants at the Head 
Start centers with the option of postage-paid mailings directly to/from their homes. The accelerometer 
data quality standards by Troiano et al,48 used by Dr. Mendoza and others,104,140-142 will be used also 
including criteria for: non-wear and wear time (non-wear time defined as 60 consecutive minutes of 
zero accelerometer counts, except for 1-2 minutes of counts between 0-100, and wear time defined by 
subtracting non-wear time from 24 hours).48  We will use the MVPA (420 counts/15 seconds) and 
sedentary cutpoints (37.5 counts/15 seconds) validated in preschoolers by Pate and colleagues.57 At 
least 5-valid days of accelerometer data with three or more hours of wear time will be used in analyses 
to estimate habitual PA, because those criteria provided >70% reliability among preschoolers.143,144 To 
maximize valid accelerometer data, participants will wear accelerometers for 24 hours/day, except for 
water-based activities,145 and re-wear them for another 7-day period if they have less than 5-valid days 
of data at each measurement time point. This approach yielded 92.5% of participants from the analytic 
sample with sufficient valid accelerometer data in the pilot Fit 5 Kids cluster RCT.40 Valid accelerometer 
wear time will be a covariate for analyses involving accelerometer data. The accelerometers will be 
provided at no cost by Dr. Mendoza. 
 
17. Moderator: Maternal depressive symptoms. Among Head Start mothers, the prevalence of 
depressive symptoms can be as high as 48%.146,147 As per a systematic review,148 maternal depressive 
symptoms have been associated with greater risk of child obesity. Maternal depressive symptoms 
assessed using the Center for Epidemiologic Studies Depression Scale (CES-D) have also been 
associated with greater screen time among US children.72,73 We will therefore measure maternal 
depressive symptoms using the validated CES-D, a 20-item instrument,111 A systematic review, which 
examined studies by racial/ethnic groups, provided support among Latinos for the original four factor 
structure (depressed affect, positive affect, somatic symptoms, and interpersonal problems) by meta-
analysis of confirmatory factor analysis studies.112 Dr. Hughes used the CES-D in a previous study 
linking parental depressive symptoms and feeding styles among parents of Head Start preschoolers.71 
The total score for mothers’ CES-D scale will be a potential moderator in analyses estimating screen 
time, with the hypothesis that the Fit 5 Kids intervention will have lower efficacy for reducing screen 
time among preschoolers of mothers with higher depressive symptoms. 
 
18. Moderator: Maternal stress. Parental stress adversely affects parenting behaviors including 
setting limits on children’s screen time and obesity. 74-76 Permitting their children to obtain excessive 
screen time may be a coping behavior used by parents in response to high stress.76 Among a sample 
consisting predominantly of mothers, parenting stress was significantly associated with lower odds of 
setting limits on their preschoolers’ screen time.75 Maternal stress was also associated with childhood 
obesity in cross-sectional and longitudinal studies as reviewed.74 To measure maternal stress, we will 
use Cohen’s Perceived Stress Scale, a validated 14-item instrument that measures the degree to which 
situations in one’s life are assessed and considered stressful on a 5-point Likert scale.113 The total 
score for perceived stress will be a potential moderator in analyses estimating screen time, with the 
hypothesis that the Fit 5 Kids intervention will have lower efficacy for reducing screen time among 
preschoolers of mothers with higher parental stress. 
 
19. Moderator: Maternal social support. While parental stress may adversely affect parenting 
behaviors and lead to greater screen time, social support is thought to moderate the impact of parental 
stress on parenting behaviors and health outcomes, i.e., Cohen’s stress-buffering hypothesis.149 For 
example in a study of low income preschoolers, social support measured by the Multidimensional Scale 
of Perceived Social Support moderated the adverse association between higher parental stress and 
higher preschoolers’ screen time.150 In a study of Head Start preschoolers, greater social support 

 
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measured by the Multidimensional Scale of Perceived Social Support was associated with parents 
highly restricting their preschoolers’ screen time.151 We will use the validated 12-item Multidimensional 
Scale of Perceived Social Support.152,153 This scale measures perceived support from family, friends, 
and a significant other, and respondents rate this on a 7-point Likert scale. The total score for social 
support will be a potential moderator in analyses estimating screen time, with the hypothesis that the Fit 
5 Kids intervention will have greater efficacy for reducing screen time among preschoolers of mothers 
with higher social support. 
 
20. Covariates: Socio-demographics. Parents will complete a survey on their child’s age, sex, 
race/ethnicity, parent education, and household income. Previous studies40,154 have reported socio-
demographics as important predictors of Latino children’s screen time, physical activity, and/or BMI z-
score. 
 
21. Covariate: Perceptions of neighborhood disorder.  We will use an 8-item,114 validated 
neighborhood disorder scale to assess parents’ perceptions of the their neighborhood in terms of 
safety, violence, drug traffic, and child victimization.115 The scale showed acceptable internal 
consistency (Cronbach’s alpha=0.95), reliability (generalizability coefficient=0.84), and validity 
comparing various neighborhoods (p<0.001).115 In previous work led by Dr. Mendoza using this scale, 
neighborhood disorder was a significant correlate of Latino Head Start preschoolers’ PA and adiposity 
(see Preliminary Studies).41,42 Total score will be a covariate. 
 
22. Covariate: Parent acculturation will be assessed using the previously validated 24-item 
Bidimensional Acculturation Scale for Hispanics. This scale consists of 3-subscales including language 
use, linguistic proficiency, and electronic media, which are combined into Hispanic and non-Hispanic 
domains.116,117 This scale had acceptable internal consistency (alpha=0.90 and 0.96 for Hispanic and 
non-Hispanic domains, respectively).116 Validity coefficients for the combined scale with generation 
status and the Short Acculturation Scale for Hispanics were high among the Mexican American and 
Latin American US sample.116 Child acculturation will be estimated using proxy measures, including 
country of origin, years living in the US, and preferred language(s), which have been associated with 
Latino preschoolers’ risk of obesity.42 
 
23. Covariate: COVID-19 Questionnaire. Derived from the World Health Organization’s 
questionnaire on behavioral insights research for COVID-19, and supplemented by additional questions 
relevant to our population from the 2020 Household Pulse Survey (U.S. Census Bureau), and Connor 
Davidson Resilience Scale 2-item. Including a COVID-19 questionnaire will allow us to adjust for how 
the pandemic affects both arms of the study. This may be an important covariate for physical activity 
and screen time outcomes given that social distancing and other stressors of the pandemic may affect 
mobility. 
 
Process evaluation. We will conduct a process evaluation of the curriculum to track and ensure proper 
dose and fidelity across the three sites and four intervention years.95 This process evaluation will 
include assessment staff directly observing class sessions and tracking teaching staff-student 
interactions and participation via a standard checklist. This checklist will include a measure of class 
time spent on each lesson, the number of children participating in the lesson with a particular emphasis 
on time spent on role-playing activities and reinforcement by teachers, the number of children 
completing lesson activities, and the number of children and parents completing take-home activities. 
We will also track resources used during lessons. The process evaluation’s assessment of role playing 
in particular will provide several measures of the curriculum’s application of Social Learning Theory.96 

 
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Role playing will directly measure modeling of behaviors by the preschool teachers for the children.97 It 
will provide a measure of the children’s rehearsal of behaviors, which facilitates retention of the 
behavior. It will also measure the number of times a teacher provides reinforcement in the form of 
positive prompts or praise during these behavior rehearsals. Finally, parent participation in the take 
home materials/lending library will be logged and also tracked by collecting assignments completed by 
the parent and children at home. 
 
Post-Intervention Qualitative Interviews. We will conduct 40 semi-structured, qualitative interviews with 
intervention participant parents after Time 3 assessments are completed. We will follow standard 
qualitative procedures for data collection and thematic analysis.172,173 Interviews will explore 
acceptability of the Fit 5 Kids intervention and how to improve intervention efficacy. Participants will be 
randomly selected with balanced representation from both the intervention and control groups, and 
even distribution across head start centers. If there is a low response (less than 60%) to the initial 
invitation to complete an interview at any center, a second round of invitations will be sent to remaining 
parents until at least 80% of the target interviews for that center are completed. 
 
A standardized interview script will be developed and consist of general open ended questions, 
followed by detailed probes and prompts to explore questions of interest. Interviews will be audio 
recorded, transcribed, verified, and translated (if necessary). We will use NVIVO, a qualitative software 
analysis program, to facilitate data coding, retrieval, and analysis. The statements in the interviews will 
be organized by specific questions. Using verbatim statements, each unit will be assigned a broad 
category and specific codes to facilitate data retrieval and analysis overall, by specific sub-categories, 
and participants’ characteristic groups. 
The multilevel Fit 5 Kids intervention consists of the classroom curriculum, weekly parent 
newsletters, in-person (or by telephone) goal setting on their child’s screen time, a lending 
library of resources (books, games, arts/crafts, etc), private parent Facebook group, and text 
messages on screen time parenting practices offered over 7-8 weeks in the Fall semester. 
There will also be two “booster” weeks of classroom activities, daily parent newsletters, goal 
setting, and daily text messages on screen time parenting practices offered during the booster 
weeks in the Spring semester. The classroom component will be taught by bilingual 
(English/Spanish) research staff interventionists. Parent newsletters, goal setting, and text 
messages will be offered in English and Spanish per parent preference. The lending library of 
resources for parents/children will be available throughout the entire school year. 
The elements unique to the proposed study include: 1) questionnaires, 2) physical activity (PA) 
and screen time data, 3) the Fit 5 Kids intervention, and 4) qualitative data, i.e., post-
intervention qualitative interviews. 
 
10.0 Data and Specimen Banking 
N/A 
 
11.0 Data Analysis/Management 

 
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We will conduct intent-to-treat analyses. Children will be the unit of analyses, although analyses will recognize 
the hierarchical nature of the data, i.e., time points nested within children, and children nested within Head 
Start centers. Randomization at the center level with stratification by study site should balance many observed 
and unobserved confounders at the center and child levels. For the primary (screen time) and other outcomes 
(BMI z-score, dietary energy intake, and MVPA), two sets of analyses will be performed. The first set of 
analysis will be separate cross-sectional analysis of T2 and T3 outcomes respectively. Given the nested 
structure of the data, we will apply mixed effects regression models156 to examine the effects of the 
intervention on each outcome while controlling for unbalanced covariates and account for correlations due to 
clustering. In the second set of analysis we will conduct a repeated measure analysis using outcomes from all 
3 time points. For Hypothesis 2, we will assess the extent through which parent outcome expectations, self-
efficacy, and screen time parenting practices exert their influence on (i.e., mediate) change in screen time via 
the intervention. We will use a structural equation modeling (SEM) approach:157,158 specifically, we will 
evaluate mediation by decomposing a total effect on the screen time slope into direct effects and indirect 
effects. The indirect effects represent the influence of the intervention on change in screen time via parent 
outcome expectations, self-efficacy, or screen time parenting practices. We will test the moderation 
relationships of Hypothesis 3 using mixed effects regression models as outlined for Hypothesis #1.  
 
Power Analysis. With only two post-intervention assessments, there is limited information on trajectories of 
outcomes over time. Thus, our primary analysis will focus on comparisons at Time 2 (post 1) and Time 3 (post 
2), respectively. We evaluated the statistical power and sample size for the proposed study using the Optimal 
Design Software.168 Parameter estimates saved from a pilot data analysis33,40 were used for population 
parameter values for data generation and coverage. We assumed an increasing attrition rate over time 
reflecting the likelihood that participants may drop out of the study (~15% overall); therefore if we power the 
study with 240 participants at Time 3, we would expect to start with approximately n=280 participants at Time 1 
with attrition. 
 
Data Management: 
Each study site will be responsible for managing the data collected at that site. All staff will be informed of the 
need for confidentiality. All key personnel at all sites will have completed Human Subjects training and all 
investigators and clinical trial staff will have up to date Good Clinical Practice (GCP) training. Data containing 
personal information such as names, addresses, and phone numbers will be maintained in a separate locked 
cabinet accessible only by the study coordinator and research manager. Security access only will be permitted 
to each file, separately, with security limited to the projects’ data manager and coordinator. Personal 
identification codes will be created for each participant, which can link quantitative or survey data back to an 
individuals’ name. Data will be stored on encrypted computers and servers that are protected with passwords. 
All data analyses will be conducted on datasets that include only the personal identification code as a linking 
variable. No names or addresses will be reported in publications. Only the PIs, co-investigators, research 
coordinator, and research administrator have keys to the offices and locked cabinets at Seattle Children’s. The 
semi-structured qualitative interview data will have no personally identifying information associated with the 
tape or the transcript, so confidentiality cannot be violated. 
 
 
12.0 Confidentiality  

 
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The semi-structured qualitative interview data will have no personally identifying information associated with 
the tape or the transcript, so confidentiality cannot be violated. The Facebook group will be private and only 
accessible to other study participants who have been invited and accepted the friend request to join the group. 
This part of the study is also optional. All YouTube videos will be unlisted with comments inactive so that only 
participants with the link will be able to access them. Digital live streams will be optional as well, and will be 
unlisted too. Viewers will need to sign in with a gmail account in order to interact with others, which participants 
may do if they choose. Any paper data will be filed in locked cabinets. Data containing personal information 
such as names, addresses, and phone numbers will be maintained in a separate locked cabinet accessible 
only by the study coordinator and research manager. Security access only will be permitted to each file, 
separately, with security limited to the projects’ data manager and coordinator. Personal identification codes 
will be created for each participant, which can link quantitative or survey data back to an individuals’ name. 
Data stored on all computers and servers will be protected with passwords. All data analyses will be conducted 
on datasets that include only the personal identification code as a linking variable. 
 
13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Prior to implementing the study, the protocols, informed consent forms, recruitment materials and 
evaluation procedures will be reviewed by the Institutional Review Boards (IRBs) of Seattle Children’s 
Hospital, the Fred Hutchinson Cancer Research Center, and Baylor College of Medicine. All adverse 
events, breach of privacy, will be recorded and reviewed by the Principal Investigator (Dr. Mendoza, a 
board-certified pediatrician and a licensed physician) and the co-investigators (Dr. O’Connor, a board-
certified pediatrician and a licensed physician, and Drs. Hughes, Zhou, and Ceballos). Any adverse 
event and the actions taken will be reported to the IRBs and NIH. As appropriate, we will refer the 
participant for the appropriate medical and psycho-social evaluation with the participant’s primary care 
provider. Each adverse event will be submitted to the IRB. 
 
This study involves minimal risk and no investigational drugs or procedures. However, the risk of an 
adverse event from reducing screen time, although recommended by national health authorities, 
warrants supervision. We have therefore appointed a Study Safety Officer, who is otherwise not 
associated with this research project but who has expertise in obesity prevention and treatment. Dr. 
Mollie Grow, MD, MPH, FAAP, a board-certified pediatrician at the University of Washington who has 
research and clinical expertise in pediatric obesity will provide oversight as follows: (1) periodically 
review and evaluate the accumulated study data for participant safety, study conduct and progress, and 
(2) assess issues concerning the continuation, modification, or termination of this study. Dr. Grow is not 
supervised by any of the members of the investigative team, nor has financial or other conflicts of 
interest with this study or its investigators. The Safety Officer, PI, co-investigators, and the Research 
Manager(s) will report any serious unexpected adverse event (whether associated with the intervention 
or not) to the IRBs and NIH within 48 hours by telephone and within 5-working days in writing. The IRBs 
will also determine whether the adverse event is causally related, probably related, possibly related, or 
unrelated to the intervention. A serious unexpected adverse event is provisionally defined as any of the 
following: 
• 
death 
• 
any acute life-threatening event or injuries 
• 
any event requiring hospitalization or emergency department care 

 
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• 
any other event that warrants a designation of a “serious” event in the PIs’, or Co-Is’ 
judgements, including threats to safety or “near-miss” injury events that could have led to items 
a-c above 
All other adverse events will be filed annually with the IRBs and the NIH. Routine monitoring for 
adverse events will be performed by the study staff and coordinators, the PI, and co-investigators. 
Since there are no investigational drugs or devices, there will be no routine post-study follow-up of 
participants. The NIH will be informed of any actions taken by the IRBs as a result of their continuing 
review of the study. 
 
 
14.0 Withdrawal of Subjects 
Subjects may withdraw from the study if the child or care-giver has a medical condition that makes it difficult or 
impossible to complete study activities. A subject may also withdraw if they cannot complete study activities for 
any other reason. If a subject revokes consent, information collected to that point that the subject withdraws in 
writing may be used if that information is necessary to complete the study. Subjects who withdraw will not be 
replaced. 
15.0 Risks to Subjects 
 
This proposed RCT involves minimal risk to the participants because it is focused on reducing 
preschool participants’ screen time, which is consistent with national health recommendations such as 
the American Academy of Pediatrics and Healthy People 2020. Data on PA and screen time, such as 
measured by accelerometers or screen time diaries, are generally not considered sensitive and are 
similar to data on household income, education, and occupation. Participant can withdraw from the 
study at any time without prejudice.   
15.1 The primary risks will be that a child could (1) become embarrassed from having weight 
measured; or (2) become embarrassed from the potential loss of confidentiality.  
The primary risk for the qualitative interviews is a loss of confidentiality (privacy).  
The semi-structured qualitative interview data will have no personally identifying 
information associated with the tape or the transcript, so confidentiality cannot be violated. 
The Facebook group will be private and only accessible to other study participants who 
have been invited and accepted the friend request to join the group. This part of the study 
is also optional. Any paper data will be filed in locked cabinets. Data containing personal 
information such as names, addresses, and phone numbers will be maintained in a 
separate locked cabinet accessible only by the study coordinator and research manager. 
Security access only will be permitted to each file, separately, with security limited to the 
projects’ data manager and coordinator. Personal identification codes will be created for 
each participant, which can link quantitative or survey data back to an individuals’ name. 
Data stored on all computers and servers will be protected with passwords. All data 
analyses will be conducted on datasets that include only the personal identification code 
as a linking variable. 
15.2 We do not expect any other parts of the study to introduce risks to the participants.   
15.3 There will be no risk to an embryo or fetus should the subject be or become pregnant. 

 
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15.4 There will be no risks to others that are not subjects. 
16.0 Potential Benefits to Subjects 
16.1 Participants may benefit from the intervention by increasing their reading, physical activity, 
family meals, etc., which may improve their weight status and decrease risk of chronic 
diseases. The proposed multilevel intervention is low cost, requires minimal project staff to 
implement (future iterations would train Head Start teachers themselves to teach Fit 5 
Kids), and could potentially have a major public health impact on the health of Latino 
populations in Head Start and similar child care settings. The benefits clearly outweigh the 
risks, as seen by guidelines for limiting children’s screen time by the American Academy of 
Pediatrics and US Healthy People 2020. 
17.0 Vulnerable Populations 
Besides the parents of the preschool children, the primary population of the proposed study will 
include children who are ages 3-5 years; thus, applying the NIH definition of children as ages 17 
years and under, children will be a focus of this study. For this age group, which represents a 
developmentally important formative period towards long term screen time behaviors, 
intervening to promote reduction of screen time and decrease risk of obesity and related chronic 
diseases are national priorities. We expect 50% of child participants to be female. As we are not 
asking about pregnancy status, it is possible that we may inadvertently enroll women who are 
pregnant or become pregnant during the study. Due to the minimal risk nature of the study 
activities, we do not anticipate any adjustments needed for pregnant participating parents. We 
will not be enrolling wards of the state. 
18.0 Community-Based Participatory Research 
N/A 
19.0 Sharing of Results with Subjects 
Subjects may request aggregate data and any publications that may result from study activities.  No 
individual data will be disseminated. 
20.0 Setting 
We will recruit Head Start centers in three different regions of the US, in order to increase 
generalizability of study findings, as well as to be inclusive of the most underserved of Latino 
groups, i.e., rural Latinos. We will recruit 8 Head Start centers in the Seattle-metro area, which 
include urban and suburban-based centers. We will recruit 6 centers from the rural Central 
Valley of Washington State. We will also recruit 6 centers from the Houston-metro area, which 
include urban-based centers.  
The Puget Sound Educational Services District (PSESD) is a state mandated educational 
services district in Washington State. PSESD operates 26 Head Start centers throughout the 
Seattle-metro area which enroll 863 Latino preschoolers. PSESD has agreed to partner with the 
investigators (see letter of support from Ms. Sharon Judie). In the rural Central Valley of 
Washington State, Inspire Centers operates 28 Head Start centers serving over 600 Latino 
preschoolers and will participate in this study (see letter of support from Mr. Jorge Castillo). In 

 
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Houston, AVANCE, Inc. operates 13 Head Start centers that serve 920 Latino preschoolers and 
has expressed a desire to participate in this study (see letter of support from Mr. Jose Villareal).  
Research staff will recruit participants from these Head Start centers. Other Head Start centers 
will also be invited to participate, including Denise Louie Education Centers (based in 
Seattle,WA) and Educational Opportunities for Children and Families (based in Vancouver, 
WA). Seattle Children’s investigators will be conducting/overseeing the research procedures at 
the Head Start centers and the investigators will be acting as agents of Seattle Children’s at 
those sites. Participants will also complete some of the study components on their own at their 
home. 
21.0 Resources Available 
The facilities and other resources at the Seattle Children’s Research Institute (SCRI) include everything that is 
needed for the successful completion of this project in a timely manner. As described below, both the facilities 
and the intellectual environment contribute to an atmosphere providing research connections, which will 
enhance completion of this project. Investigators and research staff are supported and encouraged as they 
pursue their research goals. SCRI has a history of successful grant funding, timely and novel research studies, 
and peer-reviewed publications. 
 
The Seattle Children’s Research Institute (SCRI) is composed of seven interdisciplinary research centers that 
address areas central to pediatric health and use an “open lab” format to foster a rich collaborative 
environment. Directed by Dr. James Hendricks, SCRI is sponsored by the University of Washington 
Department of Pediatrics and Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute as part of 
a $400 million dollar research funding initiative. Total research funding for SCRI in 2016 exceeded $100 
million, which places it among the top five pediatric research centers in the US. 
 
Drs. Mendoza (PI) and Zhou are investigators in the SCRI Center for Child Health, Behavior and Development 
(CHBD). CHBD is devoted to improving children’s well-being in their homes, neighborhoods, schools, clinics 
and during hospitalization through research, including physical activity promotion and obesity treatment and 
prevention. Directed by Dr. Dimitri Christakis, the center uses state-of-the-art research methods to identify 
problems and risks for children, with a special emphasis on vulnerable populations. There are currently 68 
principal investigators at CHBD with varied research interests and over $14 million in annual extramural grant 
support. CHBD’s particular areas of interest include: obesity prevention and treatment, clinical effectiveness, 
health outcomes, quality of care, community-engaged research, information technology, and health 
informatics. 
 
CHBD maintains its own Biostatistics, Epidemiology, Econometrics and Programming (BEEP) Core, which 
provides state-of-the-art statistical design, data programming, and analysis services. The BEEP Core includes 
both PhD and Masters level biostatisticians, epidemiologists, and programmers, who have the training, 
experience, and resources to handle a wide variety of statistical and programming tasks needed for clinical and 
health services research. The Core is directed by Dr. Waylon Howard, PhD, who ensures that all funded 
projects are matched with a Core member having the needed skills and experience, and who supervises the 
allocation of Core members across projects. Core members have access to the latest statistical and survey 
management software, including SPSS, SAS, Stata/SE, Mplus, R, REDCap, and DAT-STAT Illume. Core 
members attend a monthly journal club with faculty biostatisticians from SCRI and the UW, where they learn 
how to apply the latest methodological research to their activities at CHBD. Core members are skilled in 

 
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collecting, processing, and analyzing Actigraph accelerometer data. Core members also attend specialized 
analytic training opportunities offered by NIH, universities, and institutes. 
 
The Research Manager will provide expertise in in protocol development and implementation, hiring and 
supervision of study staff, and collection and management of study data.  
 
The study coordinator (TBN) and other research staff will be selected based on their experience working 
directly with children and families to obtain consent, administer questionnaires, and organize lab study visits. 
They will also have familiarity with protocol-based assessments and experience working with a varied 
participant population. 
 
22.0 Prior Approvals 
This study has undergone peer scientific review through the NIH (funding sponsor), and is 
also supported by a number of qualified professionals as stated in the grant letters of 
support. 
23.0 Recruitment Methods 
We will recruit 8 Head Start centers in the Seattle-metro area, which include urban and suburban-based 
centers. The Puget Sound Educational Services District (PSESD) is a state mandated educational 
services district in Washington State. PSESD operates 26 Head Start centers throughout the Seattle-
metro area which enroll 863 Latino preschoolers. PSESD has agreed to partner with the investigators. 
24.0 We will use recruiting strategies that have previously been highly successful for the 
investigators during studies conducted in Head Start centers over the past 10-15 years. We 
will recruit participants from Head Start centers that serve substantial numbers of Latino 
families and use a combination of recruitment procedures including 1) pictorial bilingual flyers 
sent home with the children, 2) telephone calls, 3) presentations at parent meetings, 4) active 
involvement/guidance of the Head Start manager and staff in the recruitment process, and 5) 
the use of a recruitment video. The recruitment video will be available for viewing via the same 
link participants will use to access and complete the electronic consent form process, and will 
also be available as a separate YouTube link, which school and study staff may share with 
potential participants in the same way the electronic consent form would be shared. At the 
beginning of the school year, we will provide head start centers $400. Then, we will provide $500 per 
center incentive near the end of the school year. 
25.0 Use of Social Media 
25.1 
Describe the types of social media to be employed  and rationale for the use of social 
media 
As found in related studies, use of a private Facebook group was helpful for sharing 
information, providing support, and overall participant engagement.  
25.2 
Describe the measures in place to protect the privacy or confidentiality of subjects.   
Access to the group will be limited to participating parents in the current intervention. 
Participants will be invited to join the group and will need to accept the request to then 

 
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participate and view content from other users. The group content will not be visible to the 
participant’s other Facebook friends.  
25.3 
Provide a definition of what will be considered IRB-reviewable subject matter. 
Any intervention-related content initiated by a member of the study team will first be 
submitted to the IRB for review and approval. We do not have any specific plans at this 
time for this type of content. 
25.4 
Describe whether user-generated content will be active, and if so, how it will be 
monitored and what actions will be taken to ensure subject safety and study integrity. 
A member of the study team will regularly monitor participant interactions to ensure they 
are appropriate, respectful, and related to the intervention. Participants posting 
inappropriate material will receive an initial warning and reminder of the purpose of the 
group. A second infraction will result in removal from the group. Additionally, a member 
of the study team will be in 1:1 contact with any affected participants to assess the need 
for further action. In our experience across several studies with a range of populations 
this has never been an issue with this type of private group. 
 
Post-intervention analysis will be focused on overall activity of the group and participant 
engagement (number of active participants, number of posts, likes, views). 
 
26.0 Local Number of Subjects 
Ten child care centers (with a minimum of 12 students in each) will be recruited in the Seattle 
area.  
27.0 Provisions to Protect the Privacy Interests of Subjects 
The primary risk in the proposed study revolves around privacy and data confidentiality. In order to 
protect against these risks we will do the following: risks to the participants will be fully explained during 
the informed consent process and repeated as needed during subsequent study visits and contact with 
study personnel; all the study personnel will undergo extensive, standardized training and certification 
with ongoing quality control monitoring; we will adhere to strict data storage and confidentiality 
procedures to ensure the privacy and confidentiality of the participants. In addition, study personnel will 
follow HIPAA regulations and be trained and certified in Human Subjects Protections. In addition, they 
will remind participants that they can skip any questions they are uncomfortable answering on the 
questionnaire. 
28.0 Compensation for Research-Related Injury 
N/A 
29.0 Economic Burden to Subjects 
There will be no costs to participants in the study. 
30.0 Consent Process 

 
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Due to the minimal risk nature of the study, we will be obtaining consent from one parent or 
guardian prior to enrollment in the study.   
1. 
Potential participants will first hear about the study through their child’s 
head start center. In addition to receiving information about the study during 
classroom presentations, parent-teacher conferences, and home visits, the 
information packet (cover letter, flyer, and consent form in English and Spanish) 
will be sent home with the child.  
2. 
The cover letter will provide instructions for who to contact with questions, 
and instructions for returning the signed consent to the school with their child or 
by mail with included mailing supplies and postage. The cover letter will also 
serve as a cover email in the event that consent forms are emailed to 
participants. To allow the parent sufficient time to review study materials and 
contact study staff with any questions, they will be given 2 weeks to review the 
consent form and decide if they wish to provide consent and enroll in the study.  
During this time, there will be ample opportunity to contact bilingual study team 
members to ask questions or to seek clarification.  Participants will be 
encouraged to contact the PI or study staff should they have questions. Study 
staff will also be available to discuss the study in detail with participants.    
3. 
Potential participants will be given 2 weeks to decide if they wish to 
consent to be in the study and speak with a study team member. In most cases 
participants will not have direct face-to-face contact with study staff during 
enrollment, so will not feel pressured to enroll in the study.     
4. 
If at any time the participant wishes to withdraw from the study for any reason, they 
may do so. 
5. 
We will be following “SOP: Informed Consent Process for Research (HRP-090)” with 
the following exceptions as this is a minimal risk study: 
o 
We will seek the consent of only one parent or guardian.   
o 
A formal face-to-face oral consent process will not take place.  However, 
should participants have questions, study staff will be available to meet with 
participants to discuss the study in detail.    
The voluntary nature of the study will be emphasized at many points in the 
enrollment process including when parents receive study materials, when the 
study is discussed in their child’s classroom or during other parent meetings, and 
again when they review and sign the consent (on paper or online). Once the 
parents enroll in the study, the study team will contact them to proceed with 
baseline data collection. During this contact with parents, study staff will confirm 
with the parents/legal guardian that they actually want to participate and ensure 
they understand their consent to participate in the study. Additionally, since the 
study activities occur over many weeks parents have the option of changing their 
mind at any time during the study and no longer completing study activities. 
In addition to receiving the signed consent (on paper or online), parent’s 
understanding of the study activities and confirmation that the child’s actual 

 
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parent signed the form will be informed by the parent’s subsequent actions 
including completing the baseline surveys, and participating in at-home activities. 
The survey is collected from the parent before any study activities begin in the 
child’s classroom. 
Study participants will be the parent/legal guardian who signs the consent form 
and their child. The parent and child study participants will be the only ones that 
we collect data from during the study. 
Some of the participants in the study may need to complete the informed consent 
form electronically. PHI is needed to complete the study surveys, so an alteration 
of HIPAA is needed. Providing participants with the option of providing consent 
electronically could allow more families from our target population to participate 
in the study. We will obtain written consent from every parent participant where it 
is possible, but requiring written consent for every participant may exclude some 
families from participating in the study. For example, some parents may want to 
participate in the study, but due to lack of adequate transportation might not be 
able to attend a classroom presentation. We would like to offer them the option of 
reviewing the form and providing consent and authorization electronically, with 
the study team available to address questions at any time. We do not want to 
exclude families due to barriers to completing the written consent. For families 
with barriers to completing written consent, we would like to offer the option of 
electronic consent, so we need the alteration of HIPAA for them to participate in 
the study. In these circumstances, it would be impracticable for the study team to 
conduct the research without the alteration because the research team will have 
no in-person contact with the families or have any contact information (not 
disclosed by the schools) to be able to approach the families. The research staff 
would rely on the families receiving the recruitment packets (with approach letter, 
flyer and consent forms) and have them review the content at their own pace. If 
they are interested in participating, they would then have the option of complete 
the consent form/authorization online. Our plan for protection of PHI is included 
in the data management and privacy protection sections of this protocol. 
Paper signed consent forms will be kept in the Study Coordinator’s locked office 
files, and online consent forms will be sent and stored via the UW REDCap 
database.  
Waiver or Alteration of Consent/Assent/Permission 
Reason for requesting a waiver or alteration of informed consent/assent/permission: 
o Requesting a waiver of consent for participants who turn 18. Participants were 
enrolled as pre-schoolers in 2022, so none have yet turned 18. 
o Participants have completed all study activities and we will not be collecting any 
new information (including from their medical records). The study has remained 
open for analysis of identifiable data and we have had no contact with 
Commented [WC1]: I’ve tracked in the waivers into the 
protocol consent section. Please remove the rationale from 
the Mod Summary. Please review to ensure I’ve captured 
everything correctly and revise as needed for accuracy.  
Commented [CT2R1]: Rationale has been removed from the 
mod summary. 

 
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participants for several years. The aims of the study require use of the home 
address to study child outcomes. Due to the length of time since the child 
participated, the brief duration of their involvement, and the non-sensitive and 
minimal risk nature of the data we are requesting a waiver of re-consent. 
Consent/Assent Waiver/Alteration Criteria Justifications: 
 
The research involves no more than minimal risk to the subjects because: The 
remaining study activities are limited to analysis of data with home address 
identifiers. Any data that is published from this analysis will be grouped such that it 
will not be possible to identify a given individual. 
 
The waiver or alteration will not adversely affect the rights or welfare of the subjects 
because: The child will have no additional risk or benefit as a result of not re-
consenting. Data provided is non-sensitive and will be grouped with data from other 
participants for analysis and publication. Any publication or presentation of research 
results would be done in a manner that would never reveal an individual’s identity 
either directly or indirectly. 
 
The research could not practicably be carried out without the waiver or alteration 
because: The funding for the grant the data was collected under has ended and 
participants who will turn 18 are not likely living at the same address or have the 
same contact information. As contacting them would not provide any additional 
benefit or inform of any additional risk, this would present an incredible burden on the 
investigator to try and track down and re-consent these participants. 
 
If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format because: The primary aims of 
the study involve child health and physical activity. One factor in the analysis is the 
location of the home and details about the surrounding neighborhood, so it is 
necessary to retain home address until the analysis are completed. 
 
Whenever appropriate, the subjects or legally authorized representatives will be 
provided with additional pertinent information after participation: 
N/A 
Non-English Speaking Subjects 
6. 
Participants in the study must speak either English or Spanish.  All recruitment 
documents, including the consent form, will be provided in both languages.  All 
documents will be translated and back translated from English to Spanish by a 
certified translator.  Bilingual research staff fluent in both Spanish and English will 
also be available should participants have questions during the consent process.  As 
this is a minimal risk study; a formal face-to-face oral consent process will not take 
place.  However, should participants have questions, study staff will be available to 

 
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meet with participants to discuss the study in detail. When consent activities occur 
for a Spanish speaking participant, the consent activities will be completed by a 
certified bilingual researcher.    
7. 
This study will follow the steps outlined in the Investigator Manual.   
8. 
Parent participants must be over the age of 18.  Child participants will be age 3-5.  
We will not re-consent at age 18 as no participant will reach the age of 18 during the 
study period.   
9. 
Planned emergency research is not applicable to this study. 
Subjects who are not yet adults (infants, children, teenagers) 
10. We will enroll 3-5 year old children, who do not have the developmental capacity to 
make an informed decision with regard to participating in this study.  Obtaining 
informed assent in children this young may possibly be coercive, since children of 
this age are highly suggestible to adults.  Should the child express they do not want 
to participate in the study at any time, the process will stop.   
11. Parental permission will be obtained from: 
o 
One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child. 
12. Permission will NOT be obtained from individuals other than parents. 
13. Assent will NOT be obtained from any children. We will enroll 3-5 year old children.   
o 
The capability of these children (taking into account the ages, maturity, and 
psychological state of the children involved) is so limited that they cannot 
reasonably be consulted. 
14. Requested Waiver of consent at age of majority 
Cognitively Impaired Adults 
15. We will not be enrolling cognitively impaired adults.   
Adults Unable to Consent 
16. We will not be enrolling adults unable to provide consent.   
17. No assent will be obtained as all adults enrolled will be consented. 
Consent for use of HUD 
18. NA. 
31.0 Process to Document Consent in Writing 
We will be following “SOP: Written Documentation of Consent (HRP-091). Additionally, participants will 
be given the option to review and sign the consent online via a secure REDCap portal. This will allow the study 
team to document consent while making it easier and quicker for participants to enroll. For these participants, a 
waiver of documentation of consent is requested as the REDCap module we are using does not meet criteria 
of applicable state/international law (per WA, RCW 19.34.300). In addition to having a copy of the paper 

 
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consent to review, the full content of the approved consent form will be provided online for review prior to the 
section where participants indicate consent by typing their name and the date. The activities in the research 
study are similar to what children and parents would do in their daily life and would not require consent outside 
of the research context. 
 
32.0 Drugs or Devices 
We will be using the commercially available instrument, “BioPhotonic Scanner” (Pharmanex Global 
Research, Provo, UT) to provide an objective assessment of fruit and vegetable intake via skin carotenoids. 
This is an exploratory outcome; we will simply examine correlations with fruit/veg intake, as a means of quality 
control. This is not meant to be FDA device validation, nor will it be presented as such. Additionally, we have 
cited several pediatric studies that have also used the device without the requirement of registering it with the 
FDA 
33.0 Good Clinical Practice 
We will conduct the described study per International Center for Harmonization of Good Clinical 
Practice (ICH-GCP).  
 
 
 

 
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