NCT06242808Completed
Medically Tailored Groceries and Food Resource Coaching
Medically Tailored Groceries and Food Resource Coaching for Patients of a Safety-net Clinic
Source: ClinicalTrials.gov · Last updated 31 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 210 (actual)
- First submitted
- 26 Jan 2024
- Start date
- 31 May 2024
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT06242808
What you commit to
- Study type: Interventional
- Participants enrolled: 210
- From 31 May 2024 to the primary completion date, 20 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Condition or dietary restriction that precludes eating study foods (e.g., liquid diet, eating disorder)
- Limited life expectancy, or major psychiatric illness or substance misuse that impairs participation
Other
- Another member of the household participating
- Receipt of services from Crossroads within the past 6-months
- Planning to move from the area within the next 6 months
- Unwilling to participate.
Who the study is looking for
- Income \<185% of the federal poverty threshold (self-report)
- diagnosis of Diabetes, Dyslipidemia, and/or Hypertension verified by electronic health record
- age \>18 years
- residence in one of 18 Zone Improvement Plan (ZIP) Codes served by Crossroads that surround the RedBird clinic (75203, 75208, 75211, 75212, 75216, 75217, 75224, 75232, 75233, 75236, 75237, 75241, 75249, 75052, 75104, 75115, 75116, 75137)
- Able to consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parkland Health C.V. Roman Clinic Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.