NCT05881759

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
375

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Jan 2024Mar 2027

First Submitted

Initial submission to the registry

April 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

3.2 years

First QC Date

April 13, 2023

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Nutrition Education only

ACTIVE COMPARATOR

The nutrition education group sites will receive the existing nutrition education curriculum delivered by the Houston Food Bank.

Behavioral: BEST study - Nutrition education only

Nutrition Education + Feeding Practices

ACTIVE COMPARATOR

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

Behavioral: BEST study - Nutrition education and feeding practices

Nutrition Education + Feeding Practices + Food Rx

ACTIVE COMPARATOR

The intervention site staff will implement the nutrition education-FFYF feeding curriculum-Food Rx in classes using standardized implementation protocols.

Behavioral: BEST study - Nutrition education, feeding practices, and Food Rx

Interventions

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.

Nutrition Education only

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.

Nutrition Education + Feeding Practices + Food Rx

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.

Nutrition Education + Feeding Practices

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Feeding BehaviorPediatric ObesityFood Preferences

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jayna Dave, PhD

CONTACT

Mamie White, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 31, 2023

Study Start

January 15, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

June 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations