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Childhood ObesityNCT01937481

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

A study testing The Food Friends in people with Childhood Obesity, run by Colorado State University at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
What is being tested?
The Food Friends
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
6 sitesUnited States
Study dates
Sep 2010to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • Children not entering kindergarten within one year of recruitment.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Brush School District RE 2J

    Brush, Colorado, 80723

  • Buena Vista School District

    Buena Vista, Colorado, 81211

  • Iliff Head Start

    Iliff, Colorado, 80736

  • Lake County School District

    Leadville, Colorado, 80461

  • Salida School District

    Salida, Colorado, 81201

  • RE-1 Valley School District

    Sterling, Colorado, 80751

Other trials in United States

About this study

Official title: A Longitudinal Study to Assess if the Effectiveness of a Preschool Nutrition and Physical Activity Program is Sustained in Elementary School

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?
Read the 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.

Being tested
The Food Friends
Keywords
Child, Preschool, Parents, Family, Obesity, Overweight, Diet, Overnutrition, Motor Activity, Child Care, Schools
Medical subject headings
Pediatric Obesity, Obesity, Overweight, Overnutrition, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Food FriendsBehavioural

    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.

Study groups in NCT01937481
Study groupRoleWhat they receive
Nutrition and Physical ActivityExperimentalThe Food Friends programs
Receives: Behavioral: The Food Friends
ControlNo interventionControl group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline and 2 year follow-up

Secondary outcomes (4)

  1. 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.

    Measured: baseline and 2 year follow-up

  2. 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.

    Measured: baseline and 2 year follow-up

  3. 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.

    Measured: baseline and 2 year follow-up

  4. 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.

    Measured: baseline and 2 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2013 (estimated)
  2. Study startSep 2010
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01937481
Sponsor's protocol ID
USDA NIFA 2010-85215-20648
Status last verified
Jul 2018
First submitted
28 Aug 2013
Last updated
24 Jul 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31159810

  • 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.

    PubMed 30553878

  • 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.

    PubMed 29842966

  • 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.

    PubMed 26423739

  • 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.

    PubMed 24321701

Questions about this trial

What is this clinical trial studying?

A study testing The Food Friends in people with Childhood Obesity, run by Colorado State University at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight Status (time frame: baseline and 2 year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01937481, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.

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