search
Back to results

Integrating Food Rx With Best Feeding Practices With EFNEP

Primary Purpose

Dietary Habits, Childhood Obesity, Food Selection

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Revised ESBA
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dietary Habits

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Practice - ESBA

ESBA + Feeding Practices

Arm Description

The control group sites will receive the existing ESBA curriculum which is their usual practice.

The intervention site staff will implement the ESBA-FFYF feeding curriculum in classes using standardized implementation protocols.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
May 30, 2023
Sponsor
Baylor College of Medicine
Collaborators
Prairie View A&M University, University of Houston
search

1. Study Identification

Unique Protocol Identification Number
NCT05881759
Brief Title
Integrating Food Rx With Best Feeding Practices With EFNEP
Official Title
Integrating Food Rx With Best Feeding Practices for Chronic Disease Prevention Among EFNEP Participants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 16, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Prairie View A&M University, University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Habits, Childhood Obesity, Food Selection, Feeding Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Practice - ESBA
Arm Type
No Intervention
Arm Description
The control group sites will receive the existing ESBA curriculum which is their usual practice.
Arm Title
ESBA + Feeding Practices
Arm Type
Experimental
Arm Description
The intervention site staff will implement the ESBA-FFYF feeding curriculum in classes using standardized implementation protocols.
Intervention Type
Behavioral
Intervention Name(s)
Revised ESBA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in feeding practices at 3-months will be assessed using the Food Parenting Inventory
Description
Feeding practices will be assessed using the Food Parenting Inventory
Time Frame
baseline and post-intervention at 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayna Dave, PhD
Phone
7137987195
Email
jmdave@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mamie White, MS
Phone
71379890501
Email
mawhite@bcm.edu
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayna Dave, PhD
Phone
713-798-7195
Email
jmdave@bcm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Integrating Food Rx With Best Feeding Practices With EFNEP

We'll reach out to this number within 24 hrs