The Colorado LEAP Study: A Socioecological Approach to Obesity Prevention in Early Childhood
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|ClinicalTrials.gov Identifier: NCT01937481|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2013
Last Update Posted : February 15, 2017
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?
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: The Food Friends||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||September 2010|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Oral Sensory Characteristics [ Time Frame: baseline and 2 year follow-up ]The oral sensory sensitivity scale of The Sensory Profile is administered with parents.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937481
|United States, Colorado|
|Brush School District RE 2J|
|Brush, Colorado, United States, 80723|
|Buena Vista School District|
|Buena Vista, Colorado, United States, 81211|
|Iliff Head Start|
|Iliff, Colorado, United States, 80736|
|Lake County School District|
|Leadville, Colorado, United States, 80461|
|Salida School District|
|Salida, Colorado, United States, 81201|
|RE-1 Valley School District|
|Sterling, Colorado, United States, 80751|
|Principal Investigator:||Laura L Bellows||Colorado State University|