Virtual Weight Management Shared Medical Visit

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Behavioral: Virtual shared medical visit; Behavioral: Nutritional classes

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates	Recruitment rates will be calculated by taking the number of participants enrolled over the number eligible to participate in the program	1 month
Retention of participants	Attendance at each of the sessions will be documented to assess retention of participants.	1 month
Facilitators for program participation	An investigator created questionnaire will be used to collect information about facilitators for program participation	1 month
Barriers to program participation	An investigator created questionnaire will be used to collect information about barriers to program participation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge of healthy foods	An investigator created questionnaire will be used to collect information about knowledge of healthy foods	baseline, 1 month
Change in nutritional food intake behaviours	An investigator created questionnaire will be used to collect information about nutritional food intake behaviours	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	baseline, 1 month
Change in fasting blood glucose level	Participants diagnosed with diabetes will use a home glucometer to measure fasting blood glucose levels	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.	baseline, 1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Culinary medicine; Teaching kitchens; Virtual shared medical appointments (SMA); Mind body exercises; Social Determinants of Health (SDoH)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: H-40982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No