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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Withdrawn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
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 2, 2021
    Last Updated
    August 21, 2021
    Sponsor
    Boston Medical Center
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    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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