NCT03524911

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
561

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

May 2, 2018

Last Update Submit

March 8, 2022

Conditions

Keywords

Nutrition educationEvaluationChild dietEFNEP

Outcome Measures

Primary Outcomes (1)

  • 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.

    Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.

Secondary Outcomes (1)

  • Psychosocial mediators

    Youth completed the survey at initial enrollment, after a 6-week delayed-intervention control period, and after receiving CHFFF.

Study Arms (1)

CHFFF nutrition education

EXPERIMENTAL

Expanded Food and Nutrition Education (EFNEP) participants in 5 NY counties in 2015

Behavioral: CHFFF nutrition education

Interventions

CHFFF nutrition education

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants in EFNEP nutrition education in schools and in after-school programs in 5 counties in NY during the 2014-2015 school year

You may not qualify if:

  • Younger than 3rd grade (n=3)
  • Those with fewer than 4 lessons (n=9)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pediatric ObesityMalnutrition

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wendy Wolfe, PhD

    Cornell University Division of Nutritional Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Delayed intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 15, 2018

Study Start

October 23, 2014

Primary Completion

June 11, 2015

Study Completion

June 11, 2015

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Submitting all collected IPD to the Ag Data Commons at the USDA National Agricultural Library.

Time Frame
Plan to submit in May 2018
Access Criteria
Public access
More information