Childhood ObesityNCT03524911
Choose Health: Food, Fun, and Fitness Curriculum Promotes Positive Behaviors in 3rd-5th Graders Compared to Control
A study testing CHFFF nutrition education in people with Childhood Obesity and Nutrition Poor, run by Cornell University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Nutrition Poor
- What is being tested?
- CHFFF nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2014to 11 Jun 2015
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants in EFNEP nutrition education in schools and in after-school programs in 5 counties in NY during the 2014-2015 school year
Who cannot join
- Younger than 3rd grade (n=3)
- Those with fewer than 4 lessons (n=9)
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity, Nutrition Poor
- Being tested
- CHFFF nutrition education
- Keywords
- Nutrition education, Evaluation, Child diet, EFNEP
- Medical subject headings
- Pediatric Obesity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHFFF nutrition educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CHFFF nutrition education | Experimental | Expanded Food and Nutrition Education (EFNEP) participants in 5 NY counties in 2015 Receives: Behavioral: CHFFF nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Diet
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.
Measured: Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.
Secondary outcomes (1)
Psychosocial mediators
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.
Measured: Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start23 Oct 2014
- Primary completion11 Jun 2015
- Study completion11 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Delayed intervention
- Masking
- None (open label)
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Wolfe, PhD, Principal investigator, Cornell University Division of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524911
- Sponsor's protocol ID
- CHFFF0518
- Status last verified
- Mar 2022
- First submitted
- 2 May 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Submitting all collected IPD to the Ag Data Commons at the USDA National Agricultural Library.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choose Health: Food, Fun, and Fitness Curriculum Promotes Positive Behaviors in 3rd-5th Graders Compared to Control Period
- ClinicalTrials.gov ID
- NCT03524911
- Acronym / sponsor ID
- CHFFF0518
- Conditions
- Childhood Obesity, Nutrition Poor
- Keywords
- Nutrition education, Evaluation, Child diet, EFNEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 11 Jun 2015 (actual)
- Study completion
- 11 Jun 2015 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Delayed intervention
| Arm | Type | Receives |
|---|---|---|
| CHFFF nutrition education | Experimental | Behavioral: CHFFF nutrition educationExpanded Food and Nutrition Education (EFNEP) participants in 5 NY counties in 2015 |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants in EFNEP nutrition education in schools and in after-school programs in 5 counties in NY during the 2014-2015 school year
Key exclusion criteria (2 listed)
- Younger than 3rd grade (n=3)
- Those with fewer than 4 lessons (n=9)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHFFF nutrition education | Behavioural | CHFFF nutrition education |
Primary outcome
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.
1 secondary outcome
Psychosocial mediators
Time frame: Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Choose Health: Food, Fun, and Fitness curriculum and related resourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Submitting all collected IPD to the Ag Data Commons at the USDA National Agricultural Library.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Wolfe, PhD principal investigator
Cornell University Division of Nutritional Sciences
Questions about this trial
What is this clinical trial studying?
A study testing CHFFF nutrition education in people with Childhood Obesity and Nutrition Poor, run by Cornell University.
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 2 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Child Diet (time frame: Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2022.