Medically Tailored Groceries and Food Resource Coaching
1 other identifier
interventional
210
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedStudy Start
First participant enrolled
May 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2025
CompletedJuly 31, 2025
July 1, 2025
10 months
January 26, 2024
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Study feasibility (enrollment and retention)
Study administrative data recorded by the study team on the count of people enrolled in the study and the count of people that complete the study
Participants participate for 4-months, study lasts 1-year
Adherence
Salesforce inventory data will be used to assess the nutritional quality of the food selected by participants in all groups. Healthy eating index-2015 (HEI-2015) will be applied to the food selected and scored according to National Cancer Institute (NCI) guidelines from 0-100, with 0 indicating no nutritious foods and 100 indicating all nutritious food.
Participants participate for 4-months, study lasts 1-year
Secondary Outcomes (3)
Nutrition security
Participants participate for 4-months, study lasts 1-year
Diet quality
Participants participate for 4-months, study lasts 1-year
Self-efficacy and knowledge around food procurement and healthy eating
Participants participate for 4-months, study lasts 1-year
Study Arms (3)
Usual free community food market services
ACTIVE COMPARATORUsual free community food market services, no tailoring of food received.
Medically tailored groceries and food resource coaching
EXPERIMENTALMedically tailored groceries and food resource coaching.
Medically tailored groceries
EXPERIMENTALMedically tailored groceries only, no coaching.
Interventions
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.
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)
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Condition or dietary restriction that precludes eating study foods (e.g., liquid diet, eating disorder)
- Another member of the household participating
- Receipt of services from Crossroads within the past 6-months
- Limited life expectancy, or major psychiatric illness or substance misuse that impairs participation
- Planning to move from the area within the next 6 months
- Unwilling to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas Southwestern Medical Centerlead
- Parkland Health and Hospital Systemcollaborator
- American Heart Associationcollaborator
- Crossroads Community Servicescollaborator
Study Sites (1)
Parkland Health C.V. Roman Clinic
Dallas, Texas, 75237, United States
Related Publications (1)
Albin J, Leonard T, Wong W, Siler M, Haskins C, Turcios J, Pruitt SL, Bowen M, Pezzia C, Ford A, Schinzer B, Hollis-Hansen K. Providing medically tailored groceries and food resource coaching through the charitable food system to patients of a safety-net clinic in Dallas, Texas: a randomised controlled trial protocol. BMJ Open. 2025 Jan 2;15(1):e096122. doi: 10.1136/bmjopen-2024-096122.
PMID: 39753253DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelseanna Hollis-Hansen, PhD, MPH
University of Texas Southwestern Medical Center
- PRINCIPAL INVESTIGATOR
Tammy Leonard, PhD
University of Texas Southwestern Medical Center
- PRINCIPAL INVESTIGATOR
Jaclyn Albin, MD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- It's not possible to mask the participant, care provider, or investigator due to the nature of the study, people will know if they're receiving food resource coaching. However, the investigator analyzing data will not be aware of what group assignment number corresponds to each group.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor and Principal Investigator
Study Record Dates
First Submitted
January 26, 2024
First Posted
February 5, 2024
Study Start
May 31, 2024
Primary Completion
March 20, 2025
Study Completion
April 28, 2025
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available at the time of publication. Currently, data deposited into the Texas Data Repository is available in perpetuity.
- Access Criteria
- Requesters will need to have a Texas Data Repository account and should reach out to the investigators for proper attribution and to discuss opportunities for collaboration.
For data collected by the study team, de-identified data will be hosted in the Texas Data Repository, an open-source platform for publishing and managing datasets created by Texas higher education institutions using Harvard's Dataverse software. Data available will include: a. Randomized group assignment b. Demographics measured by self-report questionnaire c. Feasibility measures from study administrative data d. Monthly appointment adherence from community food market administrative data e. Number and type of foods selected from the community food market each month from community food market administrative data f. Nutrition security survey measured by self-report questionnaire g. Dietary History Questionnaire III (DHQ-III) measured by self-report questionnaire h. Cooking and food provisioning action scale (CAFPAS) measured by self-report questionnaire