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Nutrition, HealthyNCT06242808

Medically Tailored Groceries and Food Resource Coaching

A study testing Food resource coaching, Free community food support and Medically tailored groceries in people with Nutrition, Healthy and Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nutrition, Healthy, Type 2 Diabetes, Hypertension
What is being tested?
Food resource coaching, Free community food support and Medically tailored groceries
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteUnited States
Study dates
31 May 2024to 28 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Parkland Health C.V. Roman Clinic

    Dallas, Texas, 75237

Other trials in United States

About this study

Official title: Medically Tailored Groceries and Food Resource Coaching for Patients of a Safety-net Clinic

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.

Read the detailed description

People with lower income face barriers to managing chronic diseases, such as food, housing, and economic insecurity, resource scarcity, and uncertainty around what foods meet dietary needs. Medically tailored groceries (MTG) address some barriers by providing direct access to food tailored to manage a patient's medical condition. Food resource coaching (Coach) can also address additional barriers. A food resource coach supports a patient in learning healthy eating habits when faced with financial challenges by leveraging all available food resources. For example, a coach may teach the patient how to meal plan and shop at nearby stores to improve eating patterns. Providing medically tailored groceries and food resource coaching (MTG + Coach) concurrently through a free community food market may address multiple barriers to nutrition promoting behavior change and maximize the long-term potential of Food is Medicine interventions. In this study, the investigators will recruit and enroll 210 patients of a local safety-net health center with at least one diet-related chronic condition in a randomized controlled trial. Patients will be screened for chronic diseases and income eligibility at the clinic and invited to enroll if eligible. Those who enroll will be randomized to receive MTG from a free co-located food market for 4 months (intervention 1), MTG + Coach (intervention 2) or free food from the market for 4 months (control). MTG + Coach will meet individually with a food resource coach to select MTG from the market inventory of nutritious options, discuss goals related to food and finances, and receive resources for budget management. Control can select the same amount of food from the market but will not receive tailored recommendations or interact with a coach. Feasibility, adherence, and nutritional quality of foods selected will be assessed with administrative data collected by the study team and market. Nutrition security and diet quality will be assessed with pre- and post-questionnaires. Pre- and post- qualitative interviews (N=60) will be conducted to solicit feedback on linkage to supportive services via the medical system, MTG, and MTG + Coach. MTG + Coach may provide a sustainable approach to address nutritional needs of patients with lower income as patients can utilize strategies from coaching and make MTG selections from the market after the study ends. Findings will inform a larger and longer study that assesses changes in cardiometabolic outcomes.

Being tested
Food resource coaching, Free community food support, Medically tailored groceries
Keywords
Food security, Medically tailored groceries, Food resource coaching
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food resource coachingBehavioural

    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.

  • Free community food supportOther

    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)

  • Medically tailored groceriesBehavioural

    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.

Study groups in NCT06242808
Study groupRoleWhat they receive
Usual free community food market servicesActive comparatorUsual free community food market services, no tailoring of food received.
Receives: Other: Free community food support
Medically tailored groceries and food resource coachingExperimentalMedically tailored groceries and food resource coaching.
Receives: Behavioral: Food resource coaching; Other: Free community food support; Behavioral: Medically tailored groceries
Medically tailored groceriesExperimentalMedically tailored groceries only, no coaching.
Receives: Other: Free community food support; Behavioral: Medically tailored groceries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Participants participate for 4-months, study lasts 1-year

  2. 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.

    Measured: Participants participate for 4-months, study lasts 1-year

Secondary outcomes (3)
  1. Nutrition security

    Gretchen Swanson Center for Nutrition Nutrition Security measure, 4-items, mean score with score range 0-4, higher scores indicate a greater degree of Household Nutrition Security, low scores are 2.00 or below.

    Measured: Participants participate for 4-months, study lasts 1-year

  2. Diet quality

    Healthy eating index-2015 (HEI-2015), scored according to National Cancer Institute (NCI) guidelines from 0-100, with 0 indicating no intake of nutritious foods and 100 indicating higher intake of nutritious food.

    Measured: Participants participate for 4-months, study lasts 1-year

  3. Self-efficacy and knowledge around food procurement and healthy eating

    Cooking and Food Provisioning Action Scale (CAFPAS), 11-item survey (4 self-efficacy items, 4 attitude items, and 3 structure items). Final score is a sum of the three standardized subscales with a higher score indicating greater cooking self-efficacy and food agency.

    Measured: Participants participate for 4-months, study lasts 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start31 May 2024
  3. Primary completion20 Mar 2025
  4. Study completion28 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Repeated-measures between-subjects randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06242808
Sponsor's protocol ID
STU-2023-1166
Status last verified
Jul 2025
First submitted
26 Jan 2024
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Leonard T, Albin JL, Russell C, Pruitt SL, Bowen ME, Siler M, Haskins C, Turcios J, Hollis-Hansen K. Adherence Patterns in a Randomized Controlled Trial of a Client-Choice Pantry-Based Food is Medicine Program. Am J Clin Nutr. 2026 Oct 1:101550. doi: 10.1016/j.ajcnut.2026.101550. Online ahead of print.

    PubMed 42822833
  • 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.

    PubMed 39753253

Questions about this trial

What is this clinical trial studying?

A study testing Food resource coaching, Free community food support and Medically tailored groceries in people with Nutrition, Healthy and Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study feasibility (enrollment and retention) (time frame: Participants participate for 4-months, study lasts 1-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06242808, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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