Virtual Weight Management Shared Medical Visit

Sponsor
Boston Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04784338
Collaborator
(none)
0
1
14

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual shared medical visit
  • Behavioral: Nutritional classes
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Virtual Weight Management Shared Medical Appointment: a Feasibility Study
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual shared teaching kitchen program

Participants will participate in virtual shared medical appointments that utilize the teaching kitchen

Behavioral: Virtual shared medical visit
a shared medical visit done by zoom in a group, 1.5 hours

Behavioral: Nutritional classes
A cooking class done by the teaching kitchen demonstrating cooking skills

Outcome Measures

Primary Outcome Measures

  1. Recruitment rates [1 month]

    Recruitment rates will be calculated by taking the number of participants enrolled over the number eligible to participate in the program

  2. Retention of participants [1 month]

    Attendance at each of the sessions will be documented to assess retention of participants.

  3. Facilitators for program participation [1 month]

    An investigator created questionnaire will be used to collect information about facilitators for program participation

  4. Barriers to program participation [1 month]

    An investigator created questionnaire will be used to collect information about barriers to program participation

Secondary Outcome Measures

  1. Change in knowledge of healthy foods [baseline, 1 month]

    An investigator created questionnaire will be used to collect information about knowledge of healthy foods

  2. Change in nutritional food intake behaviours [baseline, 1 month]

    An investigator created questionnaire will be used to collect information about nutritional food intake behaviours

  3. Change in blood pressure [baseline, 1 month]

    Participants will check blood pressure at home with home blood pressure cuff and record the systolic and diastolic results on home diary

  4. Change in fasting blood glucose level [baseline, 1 month]

    Participants diagnosed with diabetes will use a home glucometer to measure fasting blood glucose levels

  5. Change in body mass index [BMI] [baseline, 1 month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boston Medical Center

Investigators

  • Principal Investigator: Ivania Rizo, MD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT04784338
Other Study ID Numbers:
  • H-40982
First Posted:
Mar 5, 2021
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boston Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021