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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937481
• Other study ID #: USDA NIFA 2010-85215-20648
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Children not entering kindergarten within one year of recruitment.

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
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	RE-1 Valley School District	Sterling	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Colorado State University	University of Colorado, Denver, USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Parental Feeding and Activity Behaviors	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
Other	Changes in Home Environment	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
Other	Preschool and School Environments	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
Other	Oral Sensory Characteristics	The oral sensory sensitivity scale of The Sensory Profile is administered with parents.	baseline and 2 year follow-up
Other	Self Concept	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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