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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
Sponsor:
Collaborators:
USDA Beltsville Human Nutrition Research Center
University of Colorado, Denver
Information provided by (Responsible Party):
Colorado State University

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
Childhood Obesity Behavioral: The Food Friends Not Applicable

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  (Clinical Trial)
Estimated 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 : September 2010
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children not entering kindergarten within one year of recruitment.

Information from the National Library of Medicine

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


Locations
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT01937481     History of Changes
Other Study ID Numbers: USDA NIFA 2010-85215-20648
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Colorado State University:
Child, Preschool
Parents
Family
Obesity
Overweight
Diet
Overnutrition
Motor Activity
Child Care
Schools

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms