Clinical trial NCT01937481: The Colorado LEAP Study: A Socioecological Approach to Obesity Prevention in Early Childhood
Official title: A Longitudinal Study to Assess if the Effectiveness of a Preschool Nutrition and Physical Activity Program is Sustained in Elementary School
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Child, Preschool
Parents
Family
Obesity
Overweight
Diet
Overnutrition
Motor Activity
Child Care
Schools
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
name: University of Colorado, Denver
First posted: 2013-09-09
Enrollment: 230
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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?

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.

Eligibility 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.

Primary outcomes:
measure: Change in Weight Status
timeFrame: baseline and 2 year follow-up
Secondary outcomes:
measure: Change in Tasting Preference
timeFrame: baseline and 2 year follow-up
measure: Change in Dietary Intake
timeFrame: baseline and 2 year follow-up
measure: Change in Gross Motor Skills
timeFrame: baseline and 2 year follow-up
measure: Change in Physical Activity
timeFrame: baseline and 2 year follow-up
Other outcomes:
measure: Changes in Parental Feeding and Activity Behaviors
timeFrame: baseline and 2 year follow-up
measure: Changes in Home Environment
timeFrame: baseline and 2 year follow-up
measure: Preschool and School Environments
timeFrame: baseline
measure: Oral Sensory Characteristics
timeFrame: baseline and 2 year follow-up
measure: Self Concept
timeFrame: baseline and 2 year follow-up
Locations:
city: Brush
country: United States
facility: Brush School District RE 2J
state: Colorado
city: Buena Vista
country: United States
facility: Buena Vista School District
state: Colorado
city: Iliff
country: United States
facility: Iliff Head Start
state: Colorado
city: Leadville
country: United States
facility: Lake County School District
state: Colorado
city: Salida
country: United States
facility: Salida School District
state: Colorado
city: Sterling
country: United States
facility: RE-1 Valley School District
state: Colorado
Study officials:
affiliation: Colorado State University
name: Laura L Bellows
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson SL, Ryan SM, Kroehl M, Moding KJ, Boles RE, Bellows LL. A longitudinal intervention to improve young children's liking and consumption of new foods: findings from the Colorado LEAP study. Int J Behav Nutr Phys Act. 2019 Jun 3;16(1):49. doi: 10.1186/s12966-019-0808-3.
citation: Boles RE, Johnson SL, Burdell A, Davies PL, Gavin WJ, Bellows LL. Home food availability and child intake among rural families identified to be at-risk for health disparities. Appetite. 2019 Mar 1;134:135-141. doi: 10.1016/j.appet.2018.12.002. Epub 2018 Dec 13.
citation: Johnson SL, Moding KJ, Maloney K, Bellows LL. Development of the Trying New Foods Scale: A preschooler self-assessment of willingness to try new foods. Appetite. 2018 Sep 1;128:21-31. doi: 10.1016/j.appet.2018.05.146. Epub 2018 May 26.
citation: Johnson SL, Davies PL, Boles RE, Gavin WJ, Bellows LL. Young Children's Food Neophobia Characteristics and Sensory Behaviors Are Related to Their Food Intake. J Nutr. 2015 Nov;145(11):2610-6. doi: 10.3945/jn.115.217299. Epub 2015 Sep 30.
citation: Bellows LL, Johnson SL, Davies PL, Anderson J, Gavin WJ, Boles RE. The Colorado LEAP study: rationale and design of a study to assess the short term longitudinal effectiveness of a preschool nutrition and physical activity program. BMC Public Health. 2013 Dec 9;13:1146. doi: 10.1186/1471-2458-13-1146.