Virtual Weight Management Shared Medical Visit
Primary Purpose
Metabolic Syndrome, Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual shared medical visit
Nutritional classes
Sponsored by
About this trial
This is an interventional health services research trial for Metabolic Syndrome focused on measuring Culinary medicine, Teaching kitchens, Virtual shared medical appointments (SMA), Mind body exercises, Social Determinants of Health (SDoH)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual shared teaching kitchen program
Arm Description
Participants will participate in virtual shared medical appointments that utilize the teaching kitchen
Outcomes
Primary Outcome Measures
Recruitment rates
Recruitment rates will be calculated by taking the number of participants enrolled over the number eligible to participate in the program
Retention of participants
Attendance at each of the sessions will be documented to assess retention of participants.
Facilitators for program participation
An investigator created questionnaire will be used to collect information about facilitators for program participation
Barriers to program participation
An investigator created questionnaire will be used to collect information about barriers to program participation
Secondary Outcome Measures
Change in knowledge of healthy foods
An investigator created questionnaire will be used to collect information about knowledge of healthy foods
Change in nutritional food intake behaviours
An investigator created questionnaire will be used to collect information about nutritional food intake behaviours
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
Change in fasting blood glucose level
Participants diagnosed with diabetes will use a home glucometer to measure fasting blood glucose levels
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04784338
Brief Title
Virtual Weight Management Shared Medical Visit
Official Title
A Virtual Weight Management Shared Medical Appointment: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why 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.
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
Culinary medicine, Teaching kitchens, Virtual shared medical appointments (SMA), Mind body exercises, Social Determinants of Health (SDoH)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual shared teaching kitchen program
Arm Type
Experimental
Arm Description
Participants will participate in virtual shared medical appointments that utilize the teaching kitchen
Intervention Type
Behavioral
Intervention Name(s)
Virtual shared medical visit
Intervention Description
a shared medical visit done by zoom in a group, 1.5 hours
Intervention Type
Behavioral
Intervention Name(s)
Nutritional classes
Intervention Description
A cooking class done by the teaching kitchen demonstrating cooking skills
Primary Outcome Measure Information:
Title
Recruitment rates
Description
Recruitment rates will be calculated by taking the number of participants enrolled over the number eligible to participate in the program
Time Frame
1 month
Title
Retention of participants
Description
Attendance at each of the sessions will be documented to assess retention of participants.
Time Frame
1 month
Title
Facilitators for program participation
Description
An investigator created questionnaire will be used to collect information about facilitators for program participation
Time Frame
1 month
Title
Barriers to program participation
Description
An investigator created questionnaire will be used to collect information about barriers to program participation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in knowledge of healthy foods
Description
An investigator created questionnaire will be used to collect information about knowledge of healthy foods
Time Frame
baseline, 1 month
Title
Change in nutritional food intake behaviours
Description
An investigator created questionnaire will be used to collect information about nutritional food intake behaviours
Time Frame
baseline, 1 month
Title
Change in blood pressure
Description
Participants will check blood pressure at home with home blood pressure cuff and record the systolic and diastolic results on home diary
Time Frame
baseline, 1 month
Title
Change in fasting blood glucose level
Description
Participants diagnosed with diabetes will use a home glucometer to measure fasting blood glucose levels
Time Frame
baseline, 1 month
Title
Change in body mass index [BMI]
Description
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.
Time Frame
baseline, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivania Rizo, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Weight Management Shared Medical Visit
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