Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers (Fit5Kids)
Primary Purpose
Obesity, Childhood, Physical Activity, Nutrition
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screen Time Reduction Curriculum
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood
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.
Sites / Locations
- Baylor College of Medicine
- Seattle Children's Research Institute
- Fred Hutchinson Cancer Research Center - Center for Community Health Promotion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Screen Time Reduction Curriculum
Control
Arm Description
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.
Students will be taught the standard preschool curriculum.
Outcomes
Primary Outcome Measures
Screen Time
Change in Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)
Secondary Outcome Measures
BMI z-score
Change in Measured Height and Weight Pre-intervention vs Post-intervention
Dietary Intake by Food Screener
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
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
Change in Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+
Full Information
NCT ID
NCT03575884
First Posted
June 12, 2018
Last Updated
April 11, 2023
Sponsor
Seattle Children's Hospital
Collaborators
Fred Hutchinson Cancer Center, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03575884
Brief Title
Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers
Acronym
Fit5Kids
Official Title
Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers: A RCT
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Fred Hutchinson Cancer Center, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Physical Activity, Nutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screen Time Reduction Curriculum
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Students will be taught the standard preschool curriculum.
Intervention Type
Behavioral
Intervention Name(s)
Screen Time Reduction Curriculum
Other Intervention Name(s)
Fit5Kids
Intervention Description
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.
Primary Outcome Measure Information:
Title
Screen Time
Description
Change in Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)
Time Frame
Week 1-2, Week 11-12, and Week 34-36
Secondary Outcome Measure Information:
Title
BMI z-score
Description
Change in Measured Height and Weight Pre-intervention vs Post-intervention
Time Frame
Week 1-2, Week 11-12, and Week 34-36
Title
Dietary Intake by Food Screener
Description
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.
Time Frame
Week 1-2, Week 11-12, and Week 34-36
Title
Fruit and Vegetable Intake and Skin Carotenoids
Description
Change in Fruit and Vegetable Intake/Skin Carotenoid levels Pre-intervention vs Post-intervention, measured by Pharmanex BioPhotonic Scanner
Time Frame
Week 1-2, Week 11-12, and Week 34-36
Title
Physical Activity and Sedentary Behavior Time
Description
Change in Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+
Time Frame
Week 1-2, Week 11-12, and Week 34-36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason A Mendoza, MD, MPH
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Children's Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98145-5005
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center - Center for Community Health Promotion
City
Sunnyside
State/Province
Washington
ZIP/Postal Code
98944
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers
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