Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers

NCT03575884 | Completed Results DMC

• 2 other identifiers: Fit5Kids R01R01DK113005
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity, Childhood; Physical Activity; Nutrition

Outcome Measures

Primary Outcomes (1)

• Screen Time

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

  Week 1-2, Week 11-12, and Week 34-36

Secondary Outcomes (5)

• BMI Z-score

  Week 1-2, Week 11-12, and Week 34-36

• Dietary Intake by Food Screener Data in Grams

  Week 1-2, Week 11-12, and Week 34-36

• Fruit and Vegetable Intake and Skin Carotenoids

  Week 1-2, Week 11-12, and Week 34-36

• Physical Activity and Sedentary Behavior Time

  Week 1-2, Week 11-12, and Week 34-36

• Dietary Intake by Food Screener Data in Cups

  Week 1-2, Week 11-12, and Week 34-36

Study Arms (2)

Screen Time Reduction Curriculum

EXPERIMENTAL

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

Control

NO INTERVENTION

Students will be taught the standard preschool curriculum.

Interventions

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.

Also known as: Fit5Kids

Screen Time Reduction Curriculum

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Seattle Children's Research Institute

Seattle, Washington, 98145-5005, United States

Location

Fred Hutchinson Cancer Research Center - Center for Community Health Promotion

Sunnyside, Washington, 98944, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

The randomized controlled trial was conducted in part during the COVID-19 Pandemic and the results may have limited generalizability.

Results Point of Contact

• Title: Jason Mendoza, MD, MPH
• Organization: Seattle Children's Research Institute

Jay.Mendoza@seattlechildrens.org

206.884.1261

Study Officials

• Jason A Mendoza, MD, MPH

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 3, 2018
• Study Start: September 18, 2018
• Primary Completion: December 30, 2022
• Study Completion: July 1, 2023
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-03

Locations

US (3)