NCT06797453

Food is Medicine: Pilot Study

Food Is Medicine Shared Medical Appointments for Weight Management: A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine whether shared medical visits also called "group visits" would be beneficial for patients who are under weight management care. As part of this study, participants will be asked to complete a survey to give the study team a better idea of their current health conditions and if this study will be good fit for them. Once the survey has been completed, participants will then be randomly assigned to one of two groups. Group one will include participation in shared medical visits over a period of eight weeks. In addition to the medical visits, this group will also include two cooking classes. Group two will be asked to complete online Full Living Plate modules. Participants will be asked to complete another survey at the end of the study.

Detailed description

The purpose of this study is to have participants who are undergoing weight management attend new types of medical visits called "shared medical visits" and provide their feedback to the research staff. The shared medical visit or group visit is a new method of care delivery at Duke University Health System where patients with similar medical conditions have an appointment as a group with a provider. Patients can decide to share with the group or share privately with the provider team. Up to 50 people will take part in this study at Duke. As part of this study, participants will be asked to complete a survey prior to starting the study to make sure that they are a good fit for the study. Participants will be randomly assigned (like the flip of a coin) to one of two groups. Those placed in group one will have 4 group visit sessions that include 2 cooking demonstrations and those placed in group two will be asked to complete online Full Plate Living Modules. Both groups will receive the medically tailored groceries and can complete both the pre-survey and post-survey. Both groups will receive similar content, although only the individuals in the first option will have the opportunity to attend in-person group visit sessions. In-person sessions will be held at the Duke Integrative Medicine Center. While on study, participants will receive medically tailored groceries delivered to their home every other week. Each delivery is about 70 servings of produce with possible additional grocery items. If participants are unable to attend one of the group sessions while they are in the study, Telehealth group visits will be offered. However, this is not an alternative to an in-person class. This is being offered and approved by the study doctor on a case-by-case basis. Participation in this study will last a total of eight weeks.

Conditions

• Weight Loss

Interventions

Type	Name	Description
BEHAVIORAL	Shared Medical Visits	Shared group medical visits over eight weeks and two cooking classes.
BEHAVIORAL	Full Plate Living	Online modules teaching how a high-fiber diet can lead to more energy, lower cholesterol, better blood sugar, and easier weight loss.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-01-28
• Last updated: 2025-09-18

Locations

1 site across 1 country: United States