- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05881759
Integrating Food Rx With Best Feeding Practices With EFNEP
June 1, 2026 updated by: Jayna Dave, Baylor College of Medicine
Integrating Food Rx With Best Feeding Practices for Chronic Disease Prevention Among EFNEP Participants
To assess feasibility and acceptability of of integrating Food Rx and Best Feeding Practices with EFNEP participants via a pilot study.
Study Overview
Status
Recruiting
Detailed Description
The purpose of the pilot study is to test the FFYF feeding curriculum material and procedures for implementation, staff training, recruitment, and data collection.
Study Type
Interventional
Enrollment (Estimated)
375
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jayna Dave, PhD
- Phone Number: 7137987195
- Email: jmdave@bcm.edu
Study Contact Backup
- Name: Mamie White, MS
- Phone Number: 71379890501
- Email: mawhite@bcm.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine
-
Contact:
- Jayna Dave, PhD
- Phone Number: 7137987195
- Email: jmdave@bcm.edu
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Living in Harris or Fort Bend counties
- being a parent of a child 4-8 years old
- ability to speak in English or Spanish
- have ready access to a telephone
- have access to the Internet with a smart phone, a tablet, a laptop, or a desktop computer
Exclusion Criteria:
- parents of children with disabilities and/or those on prescription medications that affect weight and/or appetite
- parents who are not able to complete self-report questionnaires
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Nutrition Education only
The nutrition education group sites will receive the existing nutrition education curriculum delivered by the Houston Food Bank.
|
125 participants will be recruited for this arms.
All program materials will be available in English and Spanish.
Study participation will be maintained via weekly phone calls/text messaging by the study staff.
The intervention content will be delivered by the Houston Food Bank (HFB) over an 8-week period.
|
|
Active Comparator: Nutrition Education + Feeding Practices
The intervention site staff will implement the nutrition education-FFYF feeding curriculum in classes using standardized implementation protocols.
|
125 participants will be recruited for this arm.
All program materials will be available in English and Spanish.
Study participation will be maintained via weekly phone calls/text messaging by the study staff.
The nutrition education content will be delivered by the HFB over an 8-week period.
Participants will also receive messages to visit the project website and watch the videos, participate in online activities, and engage in facilitated online discussions.
|
|
Active Comparator: Nutrition Education + Feeding Practices + Food Rx
The intervention site staff will implement the nutrition education-FFYF feeding curriculum-Food Rx in classes using standardized implementation protocols.
|
125 participants will be recruited for this arm.
All program materials will be available in English and Spanish.
Study participation will be maintained via weekly phone calls/text messaging by the study staff.
The nutrition education content will be delivered by the HFB over an 8-week period.
Additionally, participants will receive messages to visit the project website and watch the videos, participate in online activities, and engage in facilitated online discussions, in addition to nutrition education delivered by the HFB.
Participants will also receive a 'Food Rx' card for bi-weekly redemption of ~30 lbs of fresh produce, plus whole grains, lean protein and low-fat dairy at a co-located HFB food pantry in addition to the nutrition education and feeding practices components.
The prescription will be eligible for redemption every two weeks for up to 9 months, for a total of 18 redemptions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in feeding practices at 3-months will be assessed using the Food Parenting Inventory
Time Frame: baseline and post-intervention at 3-months
|
Feeding practices will be assessed using the Food Parenting Inventory
|
baseline and post-intervention at 3-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 15, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
April 13, 2023
First Submitted That Met QC Criteria
May 30, 2023
First Posted (Actual)
May 31, 2023
Study Record Updates
Last Update Posted (Actual)
June 2, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-50824
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Childhood Obesity
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Universidad Autonoma de Nuevo LeonUniversidad de la SabanaCompletedPrevention Childhood ObesityMexico
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Universidad de SonoraCentro de Investigación en Alimentación y Desarrollo A.C.; Instituto Nacional...Not yet recruitingChildhood Obesity Pevention
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
Clinical Trials on BEST study - Nutrition education only
-
UConn HealthConnecticut Health FoundationCompleted
-
Universiti Putra MalaysiaCentral Sugars Refinery Sdn Bhd, MalaysiaTerminatedMetabolic Syndrome | Cardiometabolic Risk | Gene ExpressionMalaysia
-
Loma Linda UniversityCompletedSedentary LifestyleUnited States
-
Second Affiliated Hospital, School of Medicine,...UnknownNutrition Disorders | Gastric CancerChina
-
McGill UniversityInternational Development Research Centre, CanadaCompletedImproving Young Child NutritionGhana
-
Ege UniversityCompleted
-
University of MinnesotaActive, not recruitingType 2 DiabetesUnited States
-
Penn State UniversityCompletedCardiometabolic Risk FactorsUnited States
-
University of Ontario Institute of TechnologyCanadian Institutes of Health Research (CIHR)CompletedNutrition, HealthyCanada
-
Odense University HospitalBaxter Healthcare Corporation; Danish Cancer Society; Region of Southern Denmark and other collaboratorsTerminatedQuality of Life | Body Composition, Beneficial | Gastrointestinal Cancer | Dietary Modification | Cancer CachexiaDenmark