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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05881759
Other study ID # H-50824
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date March 31, 2026

Study information

Verified date February 2024
Source Baylor College of Medicine
Contact Jayna Dave, PhD
Phone 7137987195
Email jmdave@bcm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess feasibility and acceptability of of integrating Food Rx and Best Feeding Practices with EFNEP participants via a pilot study.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 31, 2026
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design


Intervention

Behavioral:
Revised ESBA
Four intervention site staff will implement the ESBA-FFYF feeding curriculum in classes using standardized implementation protocols. Two of the four intervention sites will also participate in the Food Rx program. The control group sites will receive the existing ESBA curriculum. All program materials will be available in English and Spanish. Study participation will be maintained via weekly phone calls/text messaging by the Extension staff. For the online feeding practices content, participants will receive messages to visit the project website and watch the videos, participate in online activities, and engage in facilitated online discussions. For the Food Rx arm, participants will 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 Houston Food Bank food pantry. The prescription will be eligible for redemption every two weeks for 3 months, for a total of 6 redemptions.

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
Baylor College of Medicine Prairie View A&M University, University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in feeding practices at 3-months will be assessed using the Food Parenting Inventory Feeding practices will be assessed using the Food Parenting Inventory baseline and post-intervention at 3-months
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