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NCT Number: NCT01937481

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

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?

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Key information

Conditions

Childhood Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brush School District RE 2J, Brush, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children not entering kindergarten within one year of recruitment.

Treatment and study plan

The Food Friends

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Oral Sensory Characteristics

    Time frame: baseline and 2 year follow-up

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

  5. 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).

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2013
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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