Skip to main content
OpenTrials
Completed

NCT Number: NCT06797453

Food is Medicine: Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients actively receiving care at the Duke Lifestyle and Weight Management Center (DLWMC)
  • Patients with obesity defined by BMI ≥30 kg/m2
  • Patients must live in Durham County
  • Patients age ≥18 years
  • 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
  • DLWMC provider must medically clear their participation in this program

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Shared Medical Visits

Behavioral

Shared group medical visits over eight weeks and two cooking classes.

Full Plate Living

Behavioral

Online modules teaching how a high-fiber diet can lead to more energy, lower cholesterol, better blood sugar, and easier weight loss.

Primary outcomes

  1. Acceptability of Intervention Method (AIM)

    Time frame: 0 and 12 weeks

    "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.

  2. Intervention Appropriateness Measure (IAM)

    Time frame: 0 and 12 weeks

    "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.

Secondary outcomes

  1. Fruit and Vegetable Consumption as measured by the 10-item Dietary Screener Questionnaire (DSQ)

    Time frame: 0 and 12 weeks

    The DSQ total score ranges from 0 to 100, where a higher score indicates greater fruit and vegetable consumption over the past month.

  2. Number of participants with Nutrition Security

    Time frame: 0 and 12 weeks

    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."

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Ardmore Institute of Health

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.