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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Food Friends
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Child, Preschool, Parents, Family, Obesity, Overweight, Diet, Overnutrition, Motor Activity, Child Care, Schools

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Children not entering kindergarten within one year of recruitment.

Sites / Locations

  • Brush School District RE 2J
  • Buena Vista School District
  • Iliff Head Start
  • Lake County School District
  • Salida School District
  • RE-1 Valley School District

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutrition and Physical Activity

Control

Arm Description

The Food Friends programs

Control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 28, 2013
Last Updated
July 20, 2018
Sponsor
Colorado State University
Collaborators
USDA Beltsville Human Nutrition Research Center, University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01937481
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
USDA Beltsville Human Nutrition Research Center, University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Child, Preschool, Parents, Family, Obesity, Overweight, Diet, Overnutrition, Motor Activity, Child Care, Schools

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition and Physical Activity
Arm Type
Experimental
Arm Description
The Food Friends programs
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
The Food Friends
Intervention Description
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 Outcome Measure Information:
Title
Change in Weight Status
Description
BMIz calculated from measured height and weight. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.
Time Frame
baseline and 2 year follow-up
Secondary Outcome Measure Information:
Title
Change in Tasting Preference
Description
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.
Time Frame
baseline and 2 year follow-up
Title
Change in Dietary Intake
Description
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.
Time Frame
baseline and 2 year follow-up
Title
Change in Gross Motor Skills
Description
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.
Time Frame
baseline and 2 year follow-up
Title
Change in Physical Activity
Description
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.
Time Frame
baseline and 2 year follow-up
Other Pre-specified Outcome Measures:
Title
Changes in Parental Feeding and Activity Behaviors
Description
Measured via survey. Measured at baseline, post-intervention (6 months), 1 year follow-up and 2 year follow-up.
Time Frame
baseline and 2 year follow-up
Title
Changes in Home Environment
Description
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.
Time Frame
baseline and 2 year follow-up
Title
Preschool and School Environments
Description
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.
Time Frame
baseline
Title
Oral Sensory Characteristics
Description
The oral sensory sensitivity scale of The Sensory Profile is administered with parents.
Time Frame
baseline and 2 year follow-up
Title
Self Concept
Description
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).
Time Frame
baseline and 2 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura L Bellows
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brush School District RE 2J
City
Brush
State/Province
Colorado
ZIP/Postal Code
80723
Country
United States
Facility Name
Buena Vista School District
City
Buena Vista
State/Province
Colorado
ZIP/Postal Code
81211
Country
United States
Facility Name
Iliff Head Start
City
Iliff
State/Province
Colorado
ZIP/Postal Code
80736
Country
United States
Facility Name
Lake County School District
City
Leadville
State/Province
Colorado
ZIP/Postal Code
80461
Country
United States
Facility Name
Salida School District
City
Salida
State/Province
Colorado
ZIP/Postal Code
81201
Country
United States
Facility Name
RE-1 Valley School District
City
Sterling
State/Province
Colorado
ZIP/Postal Code
80751
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31159810
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.
Results Reference
derived
PubMed Identifier
30553878
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.
Results Reference
derived
PubMed Identifier
29842966
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.
Results Reference
derived
PubMed Identifier
26423739
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.
Results Reference
derived
PubMed Identifier
24321701
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.
Results Reference
derived

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

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