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?

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

230

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Start

First participant enrolled

September 1, 2010

Completed

3 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed

12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed

Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

6.8 years

First QC Date

August 28, 2013

Last Update Submit

July 20, 2018

Conditions

Childhood Obesity

Keywords

Child, PreschoolParentsFamilyObesityOverweightDietOvernutritionMotor ActivityChild CareSchools

Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

Change in Tasting Preference
baseline and 2 year follow-up
Change in Dietary Intake
baseline and 2 year follow-up
Change in Gross Motor Skills
baseline and 2 year follow-up
Change in Physical Activity
baseline and 2 year follow-up

Other Outcomes (5)

Changes in Parental Feeding and Activity Behaviors
baseline and 2 year follow-up
Changes in Home Environment
baseline and 2 year follow-up
Preschool and School Environments
baseline
+2 more other outcomes

Study Arms (2)

Nutrition and Physical Activity

EXPERIMENTAL

The Food Friends programs

Behavioral: The Food Friends

Control

NO INTERVENTION

Control group

Interventions

The Food FriendsBEHAVIORAL

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.

Nutrition and Physical Activity

Eligibility Criteria

Age4 Years - 7 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

Children not entering kindergarten within one year of recruitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Colorado State Universitylead
USDA Beltsville Human Nutrition Research Centercollaborator
University of Colorado, Denvercollaborator

Study Sites (6)

Brush School District RE 2J

Brush, Colorado, 80723, United States

Location

Buena Vista School District

Buena Vista, Colorado, 81211, United States

Location

Iliff Head Start

Iliff, Colorado, 80736, United States

Location

Lake County School District

Leadville, Colorado, 80461, United States

Location

Salida School District

Salida, Colorado, 81201, United States

Location

RE-1 Valley School District

Sterling, Colorado, 80751, United States

Location

Related Publications (5)

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.
PMID: 31159810DERIVED
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.
PMID: 30553878DERIVED
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.
PMID: 29842966DERIVED
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.
PMID: 26423739DERIVED
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.
PMID: 24321701DERIVED

MeSH Terms

Conditions

Pediatric ObesityObesityOverweightOvernutritionMotor Activity

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

Laura L Bellows
Colorado State University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 9, 2013

Study Start

September 1, 2010

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing: Will not share

Locations

US(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (5)

Study Arms (2)

Nutrition and Physical Activity

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations