Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers (Fit5Kids)
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|ClinicalTrials.gov Identifier: NCT03575884|
Recruitment Status : Active, not recruiting
First Posted : July 3, 2018
Last Update Posted : April 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Obesity, Childhood Physical Activity Nutrition||Behavioral: Screen Time Reduction Curriculum||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers: A RCT|
|Actual Study Start Date :||September 18, 2018|
|Actual Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||January 31, 2024|
Experimental: Screen Time Reduction Curriculum
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
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.
Other Name: Fit5Kids
No Intervention: Control
Students will be taught the standard preschool curriculum.
- Screen Time [ Time Frame: Week 1-2, Week 11-12, and Week 34-36 ]Change in Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)
- BMI z-score [ Time Frame: Week 1-2, Week 11-12, and Week 34-36 ]Change in Measured Height and Weight Pre-intervention vs Post-intervention
- Dietary Intake by Food Screener [ Time Frame: Week 1-2, Week 11-12, and Week 34-36 ]
Change in 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.
- Fruit and Vegetable Intake and Skin Carotenoids [ Time Frame: Week 1-2, Week 11-12, and Week 34-36 ]Change in Fruit and Vegetable Intake/Skin Carotenoid levels Pre-intervention vs Post-intervention, measured by Pharmanex BioPhotonic Scanner
- Physical Activity and Sedentary Behavior Time [ Time Frame: Week 1-2, Week 11-12, and Week 34-36 ]Change in Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+
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|Ages Eligible for Study:||3 Years to 5 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Latino children, 3-5 years old, enrolled from 1 of the 20 Head Start Centers.
- Preschoolers do not require a minimum amount of screen time or devices in their household to enroll in the study, because it is preventive and population-based.
- Parents must be able to complete forms in English or Spanish.
- Any preschooler that is underweight or under medical supervision to gain weight.
- Only one preschooler per family may be enrolled, to avoid clustering of variables by family.
- Preschoolers may only enroll once in the study.
- Children <3 years and >5 years of age.
- Children whose parents do not identify them as Latino or Hispanic.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575884
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Children's Research Institute|
|Seattle, Washington, United States, 98145-5005|
|Fred Hutchinson Cancer Research Center - Center for Community Health Promotion|
|Sunnyside, Washington, United States, 98944|
|Principal Investigator:||Jason A Mendoza, MD, MPH||Seattle Children's Hospital|
|Responsible Party:||Jason Mendoza, MD, MPH, Principal Investigator, Seattle Children's Hospital|
|Other Study ID Numbers:||
|First Posted:||July 3, 2018 Key Record Dates|
|Last Update Posted:||April 13, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|