Food is Medicine: Pilot Study

NCT06797453 | Completed

• 1 other identifier: Pro00117065
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Loss

Keywords

Weight Management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  0 and 12 weeks

• Number of participants with Nutrition Security

  0 and 12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Completion of online Full Living Plate modules over eight weeks

Behavioral: Full Plate Living

Intervention

EXPERIMENTAL

Attend shared medical visits over eight weeks and attend two cooking classes.

Behavioral: Shared Medical Visits

Interventions

Shared Medical Visits BEHAVIORAL

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

Intervention

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.

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Ardmore Institute of Health: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nia S Mitchell, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: April 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)