Food is Medicine: Pilot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Full Plate Living; Behavioral: Shared Medical Visits

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients actively receiving care at the Duke Lifestyle and Weight Management Center (DLWMC)
2. Patients with obesity defined by BMI ≥30 kg/m2
3. Patients must live in Durham County
4. Patients age ≥18 years
5. Patients must be willing and able to consent to participating in 4 shared medical appointments with 10-13 other DLWMC patients over the course of 8 weeks
6. DLWMC provider must medically clear their participation in this program

Exclusion Criteria:

1. Patients with unstable medical or mental health condition, as deemed by their DLWMC medical provider (e.g., uncontrolled eating disorder, active severe major depression, gastrointestinal disease that would preclude consumption of a high fiber diet)
2. Patients who are pregnant or plan to become pregnant will be excluded, as change in weight will be a secondary outcome and patients may have specific dietary needs not covered by the content offered by this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Completion of online Full Living Plate modules over eight weeks	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.
Experimental: Intervention; Attend shared medical visits over eight weeks and attend two cooking classes.	Behavioral: Shared Medical Visits; Shared group medical visits over eight weeks and two cooking classes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Method (AIM)	"Acceptability" is defined as the perception among participants that a given treatment (food is medicine intervention with either group visits or online modules) is agreeable, palatable, or satisfactory. The AIM total score ranges from 1 to 20, where a higher score indicates greater acceptability.	0 and 12 weeks
Intervention Appropriateness Measure (IAM)	"Appropriateness" is defined as the perceived fit, relevance, or compatibility of the treatment (food is medicine intervention with either group visits or online modules) for the practice setting, provider, and participant; and/or perceived fit of the innovation to address obesity. The IAM total score ranges from 1 to 20, where a higher score indicates greater appropriateness.	0 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit and Vegetable Consumption as measured by the 10-item Dietary Screener Questionnaire (DSQ)	The DSQ total score ranges from 0 to 100, where a higher score indicates greater fruit and vegetable consumption over the past month.	0 and 12 weeks
Number of participants with Nutrition Security	Nutrition security is defined as "consistent access, availability, and affordability of foods and beverages that promote well-being and prevent (and if needed, treat) disease."	0 and 12 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Ardmore Institute of Health
• Investigators: Principal Investigator: Nia S Mitchell, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Weight Management
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss
• Other Study ID Numbers: Pro00117065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No