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

Sponsor
Colorado State University (Other)
Overall Status
Completed
CT.gov ID
NCT01937481
Collaborator
USDA Beltsville Human Nutrition Research Center (U.S. Fed), University of Colorado, Denver (Other)
230
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Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The Food Friends
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
230 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Longitudinal Study to Assess if the Effectiveness of a Preschool Nutrition and Physical Activity Program is Sustained in Elementary School
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: Control

Control group

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other Outcome Measures

  1. Changes in Parental Feeding and Activity Behaviors [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.

  2. Changes in Home Environment [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.

  3. Preschool and School Environments [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.

  4. Oral Sensory Characteristics [baseline and 2 year follow-up]

    The oral sensory sensitivity scale of The Sensory Profile is administered with parents.

  5. Self Concept [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Children enrolled in participating schools; entering kindergarten the year after recruitment
Exclusion Criteria:
  • Children not entering kindergarten within one year of recruitment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brush School District RE 2J Brush Colorado United States 80723
2 Buena Vista School District Buena Vista Colorado United States 81211
3 Iliff Head Start Iliff Colorado United States 80736
4 Lake County School District Leadville Colorado United States 80461
5 Salida School District Salida Colorado United States 81201
6 RE-1 Valley School District Sterling Colorado United States 80751

Sponsors and Collaborators

  • Colorado State University
  • USDA Beltsville Human Nutrition Research Center
  • University of Colorado, Denver

Investigators

  • Principal Investigator: Laura L Bellows, Colorado State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Colorado State University
ClinicalTrials.gov Identifier:
NCT01937481
Other Study ID Numbers:
  • USDA NIFA 2010-85215-20648
First Posted:
Sep 9, 2013
Last Update Posted:
Jul 24, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Colorado State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2018