Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242808
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-01-26
Brief Title:
Medically Tailored Groceries and Food Resource Coaching
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Medically Tailored Groceries and Food Resource Coaching for Patients of a Safety-net Clinic
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dont 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 two groups One group will get medically tailored groceries and food resource coaching from a free food market for four months The other 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
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 patients 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 200 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 Coach from a free co-located food market for 4 months intervention 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 N40 will be conducted to solicit feedback on linkage to supportive services via the medical system 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None