Clinical trial NCT06797453: Food is Medicine: Pilot Study
Official title: Food Is Medicine Shared Medical Appointments for Weight Management: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Loss
Keywords: Weight Management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Ardmore Institute of Health
First posted: 2025-01-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of Intervention Method (AIM)
timeFrame: 0 and 12 weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 0 and 12 weeks
Secondary outcomes:
measure: Fruit and Vegetable Consumption as measured by the 10-item Dietary Screener Questionnaire (DSQ)
timeFrame: 0 and 12 weeks
measure: Number of participants with Nutrition Security
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Ryan Kane, MD
role: PRINCIPAL_INVESTIGATOR
References: