Medically Tailored Groceries and Food Resource Coaching

July 29, 2025 updated by: Kelseanna Hollis-Hansen, University of Texas Southwestern Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75237
        • Parkland Health C.V. Roman Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Income <185% of the federal poverty threshold (self-report)
  2. diagnosis of Diabetes, Dyslipidemia, and/or Hypertension verified by electronic health record
  3. age >18 years
  4. 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)
  5. Able to consent

Exclusion Criteria:

  1. Condition or dietary restriction that precludes eating study foods (e.g., liquid diet, eating disorder)
  2. Another member of the household participating
  3. Receipt of services from Crossroads within the past 6-months
  4. Limited life expectancy, or major psychiatric illness or substance misuse that impairs participation
  5. Planning to move from the area within the next 6 months
  6. Unwilling to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual free community food market services
Usual free community food market services, no tailoring of food received.
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)
Experimental: Medically tailored groceries and food resource coaching
Medically tailored groceries and food resource coaching.
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.
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.
Experimental: Medically tailored groceries
Medically tailored groceries only, no coaching.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study feasibility (enrollment and retention)
Time Frame: Participants participate for 4-months, study lasts 1-year
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
Time Frame: Participants participate for 4-months, study lasts 1-year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutrition security
Time Frame: Participants participate for 4-months, study lasts 1-year
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.
Participants participate for 4-months, study lasts 1-year
Diet quality
Time Frame: Participants participate for 4-months, study lasts 1-year
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.
Participants participate for 4-months, study lasts 1-year
Self-efficacy and knowledge around food procurement and healthy eating
Time Frame: Participants participate for 4-months, study lasts 1-year
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.
Participants participate for 4-months, study lasts 1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Heart Association
Parkland Health and Hospital System
Crossroads Community Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kelseanna Hollis-Hansen, PhD, MPH, UT Southwestern Medical Center
  • Principal Investigator: Tammy Leonard, PhD, UT Southwestern Medical Center
  • Principal Investigator: Jaclyn Albin, MD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU-2023-1166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data will be available at the time of publication. Currently, data deposited into the Texas Data Repository is available in perpetuity.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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