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

Study Overview
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Brief Summary
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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: 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? Do The Food Friends® programs have an impact on reducing the percentage of children considered overweight and/or obese over a 3 year timeframe? Do food preference and gross motor performance directly affect child weight status or are they mediators to dietary intake and physical activity?

Detailed Description
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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.

Official Title
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A Longitudinal Study to Assess if the Effectiveness of a Preschool Nutrition and Physical Activity Program is Sustained in Elementary School

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: The Food Friends


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children enrolled in participating schools; entering kindergarten the year after recruitment Exclusion Criteria: Children not entering kindergarten within one year of recruitment.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition and Physical Activity<br>The Food Friends programs | Behavioral: The Food Friends<br>* The Food Friends is a research-based preschool program designed to address childhood obesity by establishing healthful eating and physical activity behaviors in preschool-aged children. The Food Friends: Fun With New Foods (12 weeks) focuses on helping children increasing children's willingness to try new foods and The Food Friends: Get Movin' With Mighty Moves (18 weeks) aims to enhance preschoolers' gross motor skill development. In effort to sustain the preschool behavior changes, the messages from The Food Friends® (Super Taster and Mighty Mover) will be extended into early elementary school through a 'booster' program. The booster program will consist of a kindergarten and 1st grade curriculum with 5 monthly units.<br>|
| No Intervention: Control<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tasting Preference | 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. | baseline and 2 year follow-up | 
| Change in Dietary Intake | 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. | baseline and 2 year follow-up | 
| Change in Gross Motor Skills | 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. | baseline and 2 year follow-up | 
| Change in Physical Activity | 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. | baseline and 2 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Preschool, Parents, Family, Obesity, Overweight, Diet, Overnutrition, Motor Activity, Child Care, Schools