The Colorado LEAP Study: A Socioecological Approach to Obesity Prevention in Early Childhood

Not Applicable

Completed

• Conditions: Childhood Obesity
• Interventions: Behavioral: The Food Friends

• Registration Number: NCT01937481
• Lead Sponsor: Colorado State University

Brief Summary

The Colorado Longitudinal Eating And Physical activity (LEAP) Study utilizes a social ecological approach to explore individual, family and environmental factors and their relationship to child weight status over a 3 year timeframe. Our primary research questions are as follows:

1. Are behavior changes (increased willingness to try new foods and gross motor skills) from a preschool nutrition and activity program, The Food Friends®, sustained through early elementary school?

2. Do The Food Friends® programs have an impact on reducing the percentage of children considered overweight and/or obese over a 3 year timeframe?

3. Do food preference and gross motor performance directly affect child weight status or are they mediators to dietary intake and physical activity?

Detailed Description

The preschool years are a critical time to begin obesity prevention efforts as they represent a time when young children establish healthy eating habits and physical activity patterns. These habits can place children at risk for obesity and are shaped by many characteristics, including individual characteristics as well as school, family and societal environmental characteristics. Predictive behaviors, or behavioral antecedents, within these environments can influence child behaviors. While many predictive behaviors have been shown to influence dietary intake, physical activity, and weight status, two potential behavioral antecedents - food preference and motor performance - need further exploration. Understanding the context in which child behavioral patterns are developed is critical to developing a model to address childhood obesity.

The Colorado LEAP project is a longitudinal cohort study utilizing a controlled quasi-experimental design in 5 rural Colorado communities. Two communities serve as intervention communities with the other 3 as matched controls. Intervention sites receive The Food Friends® nutrition and physical activity programs in preschool and 'booster' programming in kindergarten and 1st grade. Assessments are administered 4 times - twice in preschool (Fall and Spring) and once in both kindergarten and 1st grade (Spring). Observational measures with children are conducted at the school; parent/home measures are sent home and returned to school via the child; and school personnel complete school environment and policy assessments.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Children enrolled in participating schools; entering kindergarten the year after recruitment

Exclusion Criteria

• Children not entering kindergarten within one year of recruitment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition and Physical Activity	The Food Friends	The Food Friends programs

Primary Outcome Measures

Name	Time	Method
Change in Weight Status	baseline and 2 year follow-up	BMIz calculated from measured height and weight. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.

Secondary Outcome Measures

Name	Time	Method
Change in Dietary Intake	baseline and 2 year follow-up	Block Food Frequency Questionnaire will be completed by parents and lunch time consumption of 2 indicator foods will be observed and weighed by research staff. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.
Change in Gross Motor Skills	baseline and 2 year follow-up	The Bruininks-Oseretsky Test (BOT-2) of Motor Proficiency, Second Edition, will be used to assess gross motor development. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.
Change in Physical Activity	baseline and 2 year follow-up	Measured through pedometers and accelerometers (subsample) worn by children for 6 days. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.
Change in Tasting Preference	baseline and 2 year follow-up	Children's willingness to try new foods and liking for foods is assessed via a preference assessment administered to each child. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.

Trial Locations

Locations (6)

RE-1 Valley School District; 🇺🇸 Sterling, Colorado, United States

Brush School District RE 2J; 🇺🇸 Brush, Colorado, United States

Buena Vista School District; 🇺🇸 Buena Vista, Colorado, United States

Iliff Head Start; 🇺🇸 Iliff, Colorado, United States

Lake County School District; 🇺🇸 Leadville, Colorado, United States

Salida School District; 🇺🇸 Salida, Colorado, United States