Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers

NCT ID: NCT03575884

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2023-07-01

Brief Summary

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.

Detailed Description

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.

Conditions

Obesity, Childhood; Physical Activity; Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Screen Time Reduction Curriculum

Intervention Type: 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.

Control

Students will be taught the standard preschool curriculum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Fit5Kids

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

USDA/ARS Children's Nutrition Research Center

UNKNOWN

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jason Mendoza, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason A Mendoza, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Baylor College of Medicine

Houston, Texas, United States

Seattle Children's Research Institute

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center - Center for Community Health Promotion

Sunnyside, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK113005

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Fit5Kids R01

Identifier Type: -

Identifier Source: org_study_id