An interventional study of Screen Time Reduction Curriculum in Obesity, Childhood, Physical Activity and Nutrition, sponsored by Seattle Children's Hospital. Completed at 3 sites in United States. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Prevention
Childhood obesity and metabolic risk are at record high levels in the US, and Latino children are at very high risk. This project will test an intervention called Fit 5 Kids, designed for Latino preschoolers to decrease their screen time in order to promote physical activity and healthy eating, and to prevent obesity. Ultimately, this line of research has the potential to provide an effective program to reduce risk of obesity for Latinos in the Head Start program and other preschool-based settings.
Screen time is a major risk factor for childhood obesity and inadequate physical activity, both of which are determinants of type 2 diabetes (T2D), cardiovascular disease, and multiple cancers. Latinos are the largest and fastest growing minority in the US. Because US Latino children have more screen time and higher rates of obesity than their non-Latino White peers, interventions to reduce screen time adapted for Latino preschoolers are necessary to reduce health inequities related to obesity and T2D in the US. However, a systematic review reported no successful screen time reduction interventions among Latino preschoolers.
The investigative 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, having significantly reduced screen time by over 25 minutes/day. The investigative team's culturally adapted, multi-level intervention consists of lessons taught by study staff directly to preschoolers during Head Start, a weekly parent newsletter, and parenting tips via text messages several times/week. The investigative team will use a social ecological model and consider multiple levels of influences for analyses: (1) individual-level influences, e.g., acculturation and social cognitive theory, (2) families, e.g., screen time parenting practices, (3) schools, and (4) macro-environmental influences, e.g., neighborhood disorder. Building on this pilot work, the investigative team proposes a long term, efficacy, cluster RCT of the culturally adapted Fit 5 Kids among Latino preschoolers in Head Start from three US settings: Seattle, Houston, and the Central Valley of Washington State. Among 280 Latino 3-5 year olds at 20 Head Start centers, the investigative team's Specific Aims (SA) and Hypotheses (H) include:
SA1) To conduct a cluster RCT of the culturally adapted Fit 5 Kids curriculum to evaluate its efficacy in reducing screen time and excessive weight gain over a school year (8-months) H1) Fit 5 Kids will decrease children's screen time, BMI z-scores and dietary energy intake, and increase fruit/vegetable intake, skin carotenoids, and moderate/vigorous physical activity (MVPA) compared to controls
SA2) To examine mediators and moderators associated with reducing Latino preschoolers' screen time H2) Parents' outcome expectations, self-efficacy, and TV parenting practices will mediate the relationship between Fit 5 Kids and changes to preschoolers' screen time H3) Depressive symptoms, stress, and social support will moderate changes to preschoolers' screen time
The proposed Fit 5 Kids RCT will confirm the pilot's promising results, and the larger sample will allow for mediation analyses to better understand mechanisms. This research will provide justification for a future community effectiveness trial with implementation by Head Start teachers, and the eventual widespread implementation of Fit 5 Kids in Head Start centers nationally.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 201 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fit5Kids 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), and text messages on screen time parenting practices.
Behavioral: Screen Time Reduction Curriculum
Students will be taught the standard preschool curriculum.
Fit5Kids 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), and text messages on screen time parenting practices offered over 7-8 weeks in the Fall 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. 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 lending library of resources for parents/children will be available throughout the entire school year.
Also known as: Fit5Kids
Screen Time
Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)
Time frame: Week 1-2, Week 11-12, and Week 34-36
BMI Z-score
Measured Height and Weight Pre-intervention vs Post-intervention. Body Mass Index (BMI) Z-score, is the child's calculated standard deviation from the CDC's population reference for child's sex and age. The formula is: Z-score = ((BMI / M)L - 1) / (L × S) where BMI is body mass index, M is median, L is the transformation for normality, and S is the coefficient of variations. A Z-score of 0 represents the mean for the CDC's reference population. Z-scores above the mean generally represent a worse outcome. A Z-score of 1.645 is the 95th percentile, which is considered the threshold for obesity. (info on the above can be found here: https://www.cdc.gov/growth-chart-training/hcp/computer-programs/sas.html)
Time frame: Week 1-2, Week 11-12, and Week 34-36
Dietary Intake by Food Screener Data in Grams
Dietary Intake Pre-intervention vs Post-intervention, measured by Block Kids Food Screener (more details below) Block Food Screeners for Ages 2-17 2007: These screeners are designed to assess children's intake by food group, with outcomes measured in number of servings. The version the investigative team will use for this study is about food eaten "last week." The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets), glycemic load and glycemic index. A positive outcome would be to observe an increase in intake of fruit and vegetables, and reduced intake of saturated fats and added sugars.
Time frame: Week 1-2, Week 11-12, and Week 34-36
Fruit and Vegetable Intake and Skin Carotenoids
Fruit and Vegetable Intake/Skin Carotenoid levels Pre-intervention vs Post-intervention, measured by Pharmanex BioPhotonic Scanner. Skin carotenoids are measured using Raman spectroscopy, which returned results in units of Raman counts from 0 to 70,000. Greater Raman counts indicate greater skin carotenoids and greater fruit/vegetable intake.
Time frame: Week 1-2, Week 11-12, and Week 34-36
Physical Activity and Sedentary Behavior Time
Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+
Time frame: Week 1-2, Week 11-12, and Week 34-36
Dietary Intake by Food Screener Data in Cups
Dietary Intake Pre-intervention vs Post-intervention, measured by Block Kids Food Screener (more details below) Block Food Screeners for Ages 2-17 2007: These screeners are designed to assess children's intake by food group, with outcomes measured in number of servings. The version the investigative team will use for this study is about food eaten "last week." The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets), glycemic load and glycemic index. A positive outcome would be to observe an increase in intake of fruit and vegetables, and reduced intake of saturated fats and added sugars.
Time frame: Week 1-2, Week 11-12, and Week 34-36
We recruited from Head Start centers in three different regions: 1) Central Valley of Washington 2) Seattle, Washington 3) Houston, Texas. Research staff recruited a total of N= 22 schools and N=201 parent-child dyads to participate in the study. But, children were the focus of the intervention study outcomes. We report results pertaining to the children only. Head Start organizations in the three regions found centers for recruitment and those centers assisted in publicizing the trial.
| Milestone | Screen Time Reduction Curriculum | Control |
|---|---|---|
| Started | 92 | 109 |
| Completed | 92 | 109 |
| Not completed | 0 | 0 |
Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)
| minutes/day | Screen Time Reduction Curriculum | Control |
|---|---|---|
| Week 1-2 (Time 1) | 122.6 (96.75 to 148.44) | 123.47 (99.58 to 147.35) |
| Weeks 11-12 (Time 2) | 97.3 (70.74 to 123.86) | 129.34 (104.39 to 154.28) |
| Weeks 34-36 (Time 3) | 122.85 (96.06 to 149.64) | 151.04 (125.46 to 176.62) |
Measured Height and Weight Pre-intervention vs Post-intervention. Body Mass Index (BMI) Z-score, is the child's calculated standard deviation from the CDC's population reference for child's sex and age. The formula is: Z-score = ((BMI / M)L - 1) / (L × S) where BMI is body mass index, M is median, L is the transformation for normality, and S is the coefficient of variations. A Z-score of 0 represents the mean for the CDC's reference population. Z-scores above the mean generally represent a worse outcome. A Z-score of 1.645 is the 95th percentile, which is considered the threshold for obesity. (info on the above can be found here: https://www.cdc.gov/growth-chart-training/hcp/computer-programs/sas.html)
| score on a scale | Screen Time Reduction Curriculum Child | Control Child |
|---|---|---|
| T1 | 1.04 (0.71 to 1.37) | 0.85 (0.48 to 1.22) |
| T2 | 1.05 (.70 to 1.41) | 0.87 (0.49 to 1.25) |
| T3 | 1.33 (.86 to 1.80) | 0.55 (0.09 to 1.02) |
Dietary Intake Pre-intervention vs Post-intervention, measured by Block Kids Food Screener (more details below) Block Food Screeners for Ages 2-17 2007: These screeners are designed to assess children's intake by food group, with outcomes measured in number of servings. The version the investigative team will use for this study is about food eaten "last week." The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets), glycemic load and glycemic index. A positive outcome would be to observe an increase in intake of fruit and vegetables, and reduced intake of saturated fats and added sugars.
| Grams | Screen Time Reduction Curriculum Child | Control Child |
|---|---|---|
| T1 Saturated Fat in Grams | 13.93 (12.15 to 15.71) | 14.08 (12.50 to 15.66) |
| T2 Saturated Fat in Grams | 13.99 (12.18 to 15.81) | 12.85 (11.20 to 14.50) |
| T3 Saturated Fat in Grams | 15.16 (13.27 to 17.05) | 13.47 (11.73 to 15.20) |
| T1 Sugar in Grams | 4.97 (4.17 to 5.76) | 4.72 (4.02 to 5.43) |
| T2 Sugar in Grams | 4.89 (4.08 to 5.70) | 4.38 (3.65 to 5.12) |
| T3 Sugar in Grams | 5.01 (4.17 to 5.85) | 4.94 (4.17 to 5.71) |
Fruit and Vegetable Intake/Skin Carotenoid levels Pre-intervention vs Post-intervention, measured by Pharmanex BioPhotonic Scanner. Skin carotenoids are measured using Raman spectroscopy, which returned results in units of Raman counts from 0 to 70,000. Greater Raman counts indicate greater skin carotenoids and greater fruit/vegetable intake.
| units on a scale | Screen Time Reduction Curriculum Child | Control Child |
|---|---|---|
| Weeks 1-2 (Time 1) Skin Carotenoids | 26760.15 (16502.83 to 37017.48) | 26590.89 (16936.21 to 36245.57) |
| Weeks 11-12 (Time 2) Skin Carotenoids | 36853.57 (26106.79 to 47600.36) | 28673.47 (18804.40 to 38542.54) |
| Weeks 34-36 | 38017.93 (19313.15 to 56722.71) | 23030.60 (10777.72 to 35283.48) |
Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+
| Minutes per Day | Screen Time Reduction Curriculum Child | Control Child |
|---|---|---|
| T1 MVPA | 57.21 (47.57 to 66.86) | 66.15 (57.00 to 75.30) |
| T2 MVPA | 58.66 (48.84 to 68.48) | 57.21 (47.81 to 66.61) |
| T3 MVPA | 47.97 (37.55 to 58.40) | 49.53 (39.95 to 59.11) |
| T1 Sedentary | 647 (534.96 to 760.78) | 719.67 (610.77 to 828.57) |
| T2 Sedentary | 617.68 (503.79 to 731.58) | 649.30 (539.07 to 759.53) |
| T3 Sedentary | 530.60 (413.01 to 648.20) | 625.02 (513.90 to 736.15) |
Dietary Intake Pre-intervention vs Post-intervention, measured by Block Kids Food Screener (more details below) Block Food Screeners for Ages 2-17 2007: These screeners are designed to assess children's intake by food group, with outcomes measured in number of servings. The version the investigative team will use for this study is about food eaten "last week." The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets), glycemic load and glycemic index. A positive outcome would be to observe an increase in intake of fruit and vegetables, and reduced intake of saturated fats and added sugars.
| Cups | Screen Time Reduction Curriculum Child | Control Child |
|---|---|---|
| T1 Fruit and Fruit Juice in Cups | 1.74 (1.46 to 2.02) | 1.57 (1.31 to 1.83) |
| T2 Fruits and Fruit Juice in Cups | 1.62 (1.33 to 1.90) | 1.47 (1.20 to 1.73) |
| T3 Fruits and Fruit Juice in Cups | 1.54 (1.25 to 1.83) | 1.54 (1.27 to 1.81) |
| T1 Vegetables Without Potatoes in Cups | 0.64 (0.51 to 0.77) | 0.61 (0.49 to 0.73) |
| T2 Vegetables Without Potatoes in Cups | 0.60 (0.47 to 0.74) | 0.52 (0.40 to 0.65) |
| T3 Vegetables Without Potatoes in Cups | 0.60 (0.46 to 0.74) | 0.54 (0.42 to 0.67) |
Collected over Adverse events were collected over the course of the academic year, i.e., over ~9 months for each cohort of randomized centers and parent child dyads. This data represents 92 parent child dyads in the intervention arm, and 109 parent child dyads in the control arm.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Screen Time Reduction Curriculum | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) |
| Control | 0/109 (0%) | 0/109 (0%) | 0/109 (0%) |
This data represents 92 parent child dyads in the intervention arm, and 109 parent child dyads in the control arm.11 schools were randomized into the Control Arm, likewise 11 schools were randomized into the Intervention Arm.
| Age, Continuous(years) | Screen Time Reduction Curriculum Child | Control Child | Total |
|---|---|---|---|
| Child Age | 4.6 ± 0.72 | 4.77 ± 0.64 | 4.69 ± 0.68 |
| Parent Age | 30.39 ± 7.09 | 33.35 ± 8.02 | 32.01 ± 7.71 |
| Sex/Gender, Customized(Participants) | Screen Time Reduction Curriculum Child | Control Child | Total |
|---|---|---|---|
| Sex of Child — Female | 40 | 52 | 92 |
| Sex of Child — Male | 48 | 49 | 97 |
| Sex of Child — Missing | 4 | 8 | 12 |
| Sex of Parent — Female | 84 | 93 | 177 |
| Sex of Parent — Male | 4 | 7 | 11 |
| Sex of Parent — Missing | 4 | 9 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Screen Time Reduction Curriculum Child | Control Child | Total |
|---|---|---|---|
| Child Ethnicity — Hispanic or Latino | 87 | 95 | 182 |
| Child Ethnicity — Not Hispanic or Latino | 0 | 3 | 3 |
| Child Ethnicity — Unknown or Not Reported | 5 | 11 | 16 |
| Parent Ethnicity — Hispanic or Latino | 86 | 97 | 183 |
| Parent Ethnicity — Not Hispanic or Latino | 2 | 2 | 4 |
| Parent Ethnicity — Unknown or Not Reported | 4 | 10 | 14 |
| Race (NIH/OMB)(Participants) | Screen Time Reduction Curriculum Child | Control Child | Total |
|---|---|---|---|
| Child Race — American Indian or Alaska Native | 0 | 0 | 0 |
| Child Race — Asian | 0 | 0 | 0 |
| Child Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Child Race — Black or African American | 0 | 2 | 2 |
| Child Race — White | 69 | 82 | 151 |
| Child Race — More than one race | 2 | 4 | 6 |
| Child Race — Unknown or Not Reported | 21 | 21 | 42 |
| Parent Race — American Indian or Alaska Native | 0 | 1 | 1 |
| Parent Race — Asian | 0 | 0 | 0 |
| Parent Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Parent Race — Black or African American | 0 | 1 | 1 |
| Parent Race — White | 69 | 80 | 149 |
| Parent Race — More than one race | 3 | 3 | 6 |
| Parent Race — Unknown or Not Reported | 20 | 24 | 44 |
| Screen time(minutes/day) | Screen Time Reduction Curriculum Child | Control Child | Total |
|---|---|---|---|
| Mean | 124.23 ± 79.38 | 127.28 ± 85.44 | 125.93 ± 82.57 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seattle Children's Hospital