Weight LossNCT06797453
Food is Medicine: Pilot Study
A study testing Shared Medical Visits and Full Plate Living in people with Weight Loss, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- Shared Medical Visits and Full Plate Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Shared Medical Visits, Full Plate Living
- Keywords
- Weight Management
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Medical VisitsBehavioural
Shared group medical visits over eight weeks and two cooking classes.
Full Plate LivingBehavioural
Online modules teaching how a high-fiber diet can lead to more energy, lower cholesterol, better blood sugar, and easier weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Completion of online Full Living Plate modules over eight weeks Receives: Behavioral: Full Plate Living |
| Intervention | Experimental | Attend shared medical visits over eight weeks and attend two cooking classes. Receives: Behavioral: Shared Medical Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0 and 12 weeks
Secondary outcomes (2)
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.
Measured: 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."
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Ardmore Institute of Health
- Responsible party
- Sponsor
- Investigators
- Nia S Mitchell, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797453
- Sponsor's protocol ID
- Pro00117065
- Status last verified
- May 2025
- First submitted
- 22 Jan 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Is Medicine Shared Medical Appointments for Weight Management: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06797453
- Acronym / sponsor ID
- Pro00117065
- Conditions
- Weight Loss
- Keywords
- Weight Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Ardmore Institute of Health
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Full Plate LivingCompletion of online Full Living Plate modules over eight weeks |
| Intervention | Experimental | Behavioral: Shared Medical VisitsAttend shared medical visits over eight weeks and attend two cooking classes. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Medical VisitsShared group medical visits over eight weeks and two cooking classes. | Behavioural | Intervention |
| Full Plate LivingOnline modules teaching how a high-fiber diet can lead to more energy, lower cholesterol, better blood sugar, and easier weight loss. | Behavioural | Control |
Primary outcome
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.
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.
2 secondary outcomes
Fruit and Vegetable Consumption as measured by the 10-item Dietary Screener Questionnaire (DSQ)
Time frame: 0 and 12 weeks
Number of participants with Nutrition Security
Time frame: 0 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nia S Mitchell, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Medical Visits and Full Plate Living in people with Weight Loss, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Method (AIM) (time frame: 0 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.