Medically Tailored Groceries and Food Resource Coaching

NCT06242808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-07-31

No results posted yet for this study

Summary

Eating healthy foods can help people manage health problems, like Type 2 diabetes and heart disease. Many people want to eat healthier, but changing eating behaviors is hard. Patients don't always know what foods to eat for their health problems and are hesitant to try foods that may be unfamiliar. These challenges are made more difficult when families have lower incomes, which makes accessing healthy foods difficult and trying new foods riskier when on a budget. Food is Medicine programs connect people to healthy foods that help them manage health problems. One example is a medically tailored grocery program. This program provides a patient with free groceries selected to help their medical condition. For example, a patient receives fruits, vegetables, whole grains, and low-salt, low-sugar foods if they have high blood pressure. Food resource coaching is another strategy for eating healthy food. This approach provides a coach that supports learning healthy eating habits when facing financial challenges by using available food resources. Among other strategies, a coach may teach the participant how to meal plan and shop at nearby stores to increase healthy and delicious eating patterns. In our study, the investigators will ask lower-income patients with at least one chronic health problem at a safety-net clinic if they want to participate in a Food is Medicine program. Patients that want to participate will be randomly placed in one of three groups. One group will get medically tailored groceries from a free food market for four months. Another group will get medically tailored groceries and food resource coaching from a free food market. The last group will get free food from the same market for four months, but food will not be medically tailored, and they will not meet with a coach. Participants will have the option to continue getting food from the market at the end of the study if they want to. This study will help us learn what patients think about Food is Medicine programs and how to best carry out these programs in the future. The study will also help us determine if providing medically tailored groceries and food resource coaching helps patients improve their diet. The investigators will use what is learned in this study to create a larger and longer program that can be provided in safety-net clinics throughout Dallas-Fort Worth. Our main goal is to build a sustainable and helpful program for patients that may not otherwise have access to healthy foods and eating habits that set the foundation for better health.

Conditions

Interventions

BEHAVIORAL

Food resource coaching

Patients will meet with a food resource coach who will explain basic coaching principles including how to respond to financial crises, how to access various food resources, and the importance of consistent utilization of food resources. After the coaching session, the food resource coach will help patients select medically tailored groceries from the free community food market inventory.

OTHER

Free community food support

Usual services include selecting up to 21 meals for each person in the household from Crossroads nutritious market once per month (e.g., approximately 100 pounds \[$250 United States dollars\] of food for a family of four)

BEHAVIORAL

Medically tailored groceries

A pantry staff member helps patients select medically tailored groceries (MTG) from the free community food market inventory by prepopulating MTG in their pantry cart.

Sponsors & Collaborators

  • Parkland Health and Hospital System

    collaborator OTHER
  • American Heart Association

    collaborator OTHER
  • Crossroads Community Services

    collaborator UNKNOWN
  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Kelseanna Hollis-Hansen, PhD, MPH · UT Southwestern Medical Center

  • Tammy Leonard, PhD · UT Southwestern Medical Center

  • Jaclyn Albin, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-03-20
Completion
2025-04-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06242808 on ClinicalTrials.gov