- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524911
Choose Health: Food, Fun, and Fitness Curriculum Promotes Positive Behaviors in 3rd-5th Graders Compared to Control
March 8, 2022 updated by: Cornell University
Choose Health: Food, Fun, and Fitness Curriculum Promotes Positive Behaviors in 3rd-5th Graders Compared to Control Period
The Choose Health: Food, Fun, and Fitness (CHFFF) curriculum was evaluated in 3rd-5th graders, hypothesizing that change pre- to post- CHFFF education would be greater than in the same child during a delayed intervention control period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Choose Health: Food, Fun, and Fitness (CHFFF) is a Cornell curriculum for 3rd-6th graders targeting behaviors to prevent obesity and chronic disease risk: fewer sweetened drinks; more vegetables, fruits, and whole grains; fewer high-fat and high-sugar foods; and active play.
The 6 lessons use experiential learning, food preparation, active games, goal setting, and a family newsletter.
It was evaluated in 561 Expanded Food and Nutrition Education (EFNEP) participants in 27 after-school and 28 in-school groups in 5 NY counties in 2015 using a quasi-experimental design, with a delayed-intervention control period prior to CHFFF.
Youth completed a self-reported survey 3 times: at initial enrollment, after a 6-week no-intervention control period, and after receiving the 6 weekly CHFFF lessons.
Outcome measures included dietary intake scores created based on factor analysis, and related precursors.
It was hypothesized that change pre- to post- CHFFF education would be greater than in the same child during the delayed intervention control period.
Following CHFFF, youth improved significantly (p<.05) compared to their control period in overall diet quality, vegetable intake, fruit intake, soda/fast food intake and choice, and the frequency with which they read nutrition facts labels, shared about healthy eating with their family, and tried a new food.
Study Type
Interventional
Enrollment (Actual)
561
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants in EFNEP nutrition education in schools and in after-school programs in 5 counties in NY during the 2014-2015 school year
Exclusion Criteria:
- Younger than 3rd grade (n=3)
- Those with fewer than 4 lessons (n=9)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHFFF nutrition education
Expanded Food and Nutrition Education (EFNEP) participants in 5 NY counties in 2015
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Diet
Time Frame: Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.
|
Dietary intake was assessed via a self-reported survey, then 4 dietary scores were created based on factor analysis: overall diet quality, vegetable intake, fruit intake, and soda/fast food intake.
|
Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial mediators
Time Frame: Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.
|
Assessed via a self-report survey, these included soda/fast food choices, and the frequency with which they read nutrition facts labels, shared about healthy eating with their family, and tried a new food.
|
Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wendy Wolfe, PhD, Cornell University Division of Nutritional Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 23, 2014
Primary Completion (Actual)
June 11, 2015
Study Completion (Actual)
June 11, 2015
Study Registration Dates
First Submitted
May 2, 2018
First Submitted That Met QC Criteria
May 14, 2018
First Posted (Actual)
May 15, 2018
Study Record Updates
Last Update Posted (Actual)
March 22, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHFFF0518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Submitting all collected IPD to the Ag Data Commons at the USDA National Agricultural Library.
IPD Sharing Time Frame
Plan to submit in May 2018
IPD Sharing Access Criteria
Public access
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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