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Completed

NCT Number: NCT03575884

Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Screen Time Reduction Curriculum

Behavioral

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 names: Fit5Kids

Primary outcomes

  1. Screen Time

    Time frame: Week 1-2, Week 11-12, and Week 34-36

    Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)

Secondary outcomes

  1. BMI Z-score

    Time frame: Week 1-2, Week 11-12, and Week 34-36

    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)

  2. Dietary Intake by Food Screener Data in Grams

    Time frame: Week 1-2, Week 11-12, and Week 34-36

    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.

  3. Fruit and Vegetable Intake and Skin Carotenoids

    Time frame: Week 1-2, Week 11-12, and Week 34-36

    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.

  4. Physical Activity and Sedentary Behavior Time

    Time frame: Week 1-2, Week 11-12, and Week 34-36

    Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+

  5. Dietary Intake by Food Screener Data in Cups

    Time frame: Week 1-2, Week 11-12, and Week 34-36

    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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Baylor College of Medicine
  • Fred Hutchinson Cancer Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • USDA/ARS Children's Nutrition Research Center

Registry information

Official study title

Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers: A RCT

Acronym: Fit5Kids

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jul 3, 2018
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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