Clinical trial NCT03575884: Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers
Official title: Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers: A RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Physical Activity
Nutrition
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: Baylor College of Medicine
name: USDA/ARS Children's Nutrition Research Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-07-03
Enrollment: 201
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Screen Time
timeFrame: Week 1-2, Week 11-12, and Week 34-36
Secondary outcomes:
measure: BMI Z-score
timeFrame: Week 1-2, Week 11-12, and Week 34-36
measure: Dietary Intake by Food Screener Data in Grams
timeFrame: Week 1-2, Week 11-12, and Week 34-36
measure: Fruit and Vegetable Intake and Skin Carotenoids
timeFrame: Week 1-2, Week 11-12, and Week 34-36
measure: Physical Activity and Sedentary Behavior Time
timeFrame: Week 1-2, Week 11-12, and Week 34-36
measure: Dietary Intake by Food Screener Data in Cups
timeFrame: Week 1-2, Week 11-12, and Week 34-36
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
city: Sunnyside
country: United States
facility: Fred Hutchinson Cancer Research Center - Center for Community Health Promotion
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Jason A Mendoza, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: