Metabolic SyndromeNCT04784338
Virtual Weight Management Shared Medical Visit
A study testing Virtual shared medical visit and Nutritional classes in people with Metabolic Syndrome and Obesity, run by Boston Medical Center.
Trial summary
Culinary medicine has emerged which provides the practical application of nutrition education through experiential learning. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had weight loss, and improved cardiac… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Virtual shared medical visit and Nutritional classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Oct 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- BMI => 30
- Must have documented measured blood pressure, weight, height in the 12 months prior to the intervention
- Enrolled in Boston Medical Center's (BMC's) Food Pantry Program
Who cannot join
- Patients with advanced dementia or uncontrolled psychiatric disease
- Uncontrolled medical illness including severe hypertension, recent acute coronary syndrome, active malignancy or other condition that would make the subject unable to complete the study procedures
About this study
Official title: A Virtual Weight Management Shared Medical Appointment: a Feasibility Study
Culinary medicine has emerged which provides the practical application of nutrition education through experiential learning. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had weight loss, and improved cardiac health and blood sugar management.
Given the increasing focus on providing remote experiences to minimize contact and risk of infection with Sars-COV2, this pilot study at Boston Medical Center (BMC) will integrate a physician consultation, interactive didactic presentations, nutritious cooking and mind- body exercises. Patients with obesity and metabolic syndrome can attend a virtual shared medical visit series co-taught by a registered dietician and chef and an endocrinologist and weight management specialist. Data will be collected in the form of surveys, phone interviews, chart review, and home monitoring to test both the feasibility of running such an intervention virtually and to explore whether attending this one month program with weekly remote classes/visits improves vitals including weight and blood blood pressure and other small habit changes in patients.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Virtual shared medical visit, Nutritional classes
- Keywords
- Culinary medicine, Teaching kitchens, Virtual shared medical appointments (SMA), Mind body exercises, Social Determinants of Health (SDoH)
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual shared medical visitBehavioural
a shared medical visit done by zoom in a group, 1.5 hours
Nutritional classesBehavioural
A cooking class done by the teaching kitchen demonstrating cooking skills
| Study group | Role | What they receive |
|---|---|---|
| Virtual shared teaching kitchen program | Experimental | Participants will participate in virtual shared medical appointments that utilize the teaching kitchen Receives: Behavioral: Virtual shared medical visit; Behavioral: Nutritional classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Recruitment rates will be calculated by taking the number of participants enrolled over the number eligible to participate in the program
Measured: 1 month
Retention of participants
Attendance at each of the sessions will be documented to assess retention of participants.
Measured: 1 month
Facilitators for program participation
An investigator created questionnaire will be used to collect information about facilitators for program participation
Measured: 1 month
Barriers to program participation
An investigator created questionnaire will be used to collect information about barriers to program participation
Measured: 1 month
Secondary outcomes (5)
Change in knowledge of healthy foods
An investigator created questionnaire will be used to collect information about knowledge of healthy foods
Measured: baseline, 1 month
Change in nutritional food intake behaviours
An investigator created questionnaire will be used to collect information about nutritional food intake behaviours
Measured: baseline, 1 month
Change in blood pressure
Participants will check blood pressure at home with home blood pressure cuff and record the systolic and diastolic results on home diary
Measured: baseline, 1 month
Change in fasting blood glucose level
Participants diagnosed with diabetes will use a home glucometer to measure fasting blood glucose levels
Measured: baseline, 1 month
Change in body mass index [BMI]
Participants will weigh themselves at home and record their weight in a study diary. The BMI will be calculated using the formula BMI= kg/m2 where kg is a person's weight in kilograms and m2 is a person's height in meters squared.
Measured: baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study startAug 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: The investigators decided not to implement the research but instead to conduct a quality improvement project to focus on the practice of shared medical appointments (SMAs) and how to optimize them for clinical practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivania Rizo, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784338
- Sponsor's protocol ID
- H-40982
- Status last verified
- Aug 2021
- First submitted
- 2 Mar 2021
- Last updated
- 26 Aug 2021
- 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 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Weight Management Shared Medical Appointment: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04784338
- Acronym / sponsor ID
- H-40982
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Culinary medicine, Teaching kitchens, Virtual shared medical appointments (SMA), Mind body exercises, Social Determinants of Health (SDoH)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators decided not to implement the research but instead to conduct a quality improvement project to focus on the practice of shared medical appointments (SMAs) and how to optimize them for clinical practice.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 5 Mar 2021 (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.
Culinary medicine has emerged which provides the practical application of nutrition education through experiential learning. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had weight loss, and improved cardiac health and blood sugar management.
Given the increasing focus on providing remote experiences to minimize contact and risk of infection with Sars-COV2, this pilot study at Boston Medical Center (BMC) will integrate a physician consultation, interactive didactic presentations, nutritious cooking and mind- body exercises. Patients with obesity and metabolic syndrome can attend a virtual shared medical visit series co-taught by a registered dietician and chef and an endocrinologist and weight management specialist. Data will be collected in the form of surveys, phone interviews, chart review, and home monitoring to test both the feasibility of running such an intervention virtually and to explore whether attending this one month program with weekly remote classes/visits improves vitals including weight and blood blood pressure and other small habit changes in patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual shared teaching kitchen program | Experimental | Behavioral: Virtual shared medical visit, Behavioral: Nutritional classesParticipants will participate in virtual shared medical appointments that utilize the teaching kitchen |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- BMI => 30
- Must have documented measured blood pressure, weight, height in the 12 months prior to the intervention
- Enrolled in Boston Medical Center's (BMC's) Food Pantry Program
Key exclusion criteria (2 listed)
- Patients with advanced dementia or uncontrolled psychiatric disease
- Uncontrolled medical illness including severe hypertension, recent acute coronary syndrome, active malignancy or other condition that would make the subject unable to complete the study procedures
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 |
|---|---|---|
| Virtual shared medical visita shared medical visit done by zoom in a group, 1.5 hours | Behavioural | Virtual shared teaching kitchen program |
| Nutritional classesA cooking class done by the teaching kitchen demonstrating cooking skills | Behavioural | Virtual shared teaching kitchen program |
Primary outcome
Recruitment rates
Time frame: 1 month
Recruitment rates will be calculated by taking the number of participants enrolled over the number eligible to participate in the program
Retention of participants
Time frame: 1 month
Attendance at each of the sessions will be documented to assess retention of participants.
Facilitators for program participation
Time frame: 1 month
An investigator created questionnaire will be used to collect information about facilitators for program participation
Barriers to program participation
Time frame: 1 month
An investigator created questionnaire will be used to collect information about barriers to program participation
5 secondary outcomes
Change in knowledge of healthy foods
Time frame: baseline, 1 month
Change in nutritional food intake behaviours
Time frame: baseline, 1 month
Change in blood pressure
Time frame: baseline, 1 month
Change in fasting blood glucose level
Time frame: baseline, 1 month
Change in body mass index [BMI]
Time frame: baseline, 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- 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.
Ivania Rizo, MD principal investigator
Boston Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Virtual shared medical visit and Nutritional classes in people with Metabolic Syndrome and Obesity, run by Boston Medical Center.
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 4 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: withdrawn, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Recruitment rates (time frame: 1 month). The study lists 4 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 26 Aug 2021.