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

July 20, 2018 updated by: Colorado State University

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Brush, Colorado, United States, 80723
        • Brush School District RE 2J
      • Buena Vista, Colorado, United States, 81211
        • Buena Vista School District
      • Iliff, Colorado, United States, 80736
        • Iliff Head Start
      • Leadville, Colorado, United States, 80461
        • Lake County School District
      • Salida, Colorado, United States, 81201
        • Salida School District
      • Sterling, Colorado, United States, 80751
        • RE-1 Valley School District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group
Experimental: Nutrition and Physical Activity
The Food Friends programs
Behavioral: The Food Friends
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weight Status
Time Frame: 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.
baseline and 2 year follow-up

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Parental Feeding and Activity Behaviors
Time Frame: baseline and 2 year follow-up
Measured via survey. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.
baseline and 2 year follow-up
Changes in Home Environment
Time Frame: baseline and 2 year follow-up
A self report survey completed by parents to measure availability of food items, physical activity items, and sedentary devices in the home. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.
baseline and 2 year follow-up
Preschool and School Environments
Time Frame: baseline

Key preschool staff will complete the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) instrument to identify current center nutrition and physical activity policies and practices.

Elementary school staff will complete the School Environment and Policy Survey (SEPS), which consists of three modules designed to capture nutrition and physical activity environments, policies and programs offered in the schools.
baseline
Oral Sensory Characteristics
Time Frame: baseline and 2 year follow-up
The oral sensory sensitivity scale of The Sensory Profile is administered with parents.
baseline and 2 year follow-up
Self Concept
Time Frame: baseline and 2 year follow-up
The Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (PSPCSA) is a self-report instrument designed to assess perceptions of young children ages four to seven in four domains (i.e., Cognitive Competence, Physical Competence, Peer Acceptance, Maternal Acceptance).
baseline and 2 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Collaborators

University of Colorado, Denver
USDA Beltsville Human Nutrition Research Center

Investigators

  • Principal Investigator: Laura L Bellows, Colorado State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 9, 2013

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 20, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USDA NIFA 2010-85215-20648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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