Virtual Weight Management Shared Medical Visit

Obesity Clinical Trial

Official title:

A Virtual Weight Management Shared Medical Appointment: a Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04784338
• Other study ID #: H-40982
• Status: Withdrawn
• Phase: N/A
• Start date: August 2021
• Est. completion date: October 2022

Study information

• Verified date: August 2021
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity

Intervention

Behavioral:
• Virtual shared medical visit
a shared medical visit done by zoom in a group, 1.5 hours
• Nutritional classes
A cooking class done by the teaching kitchen demonstrating cooking skills

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Retention of participants	Attendance at each of the sessions will be documented to assess retention of participants.	1 month
Primary	Facilitators for program participation	An investigator created questionnaire will be used to collect information about facilitators for program participation	1 month
Primary	Barriers to program participation	An investigator created questionnaire will be used to collect information about barriers to program participation	1 month
Secondary	Change in knowledge of healthy foods	An investigator created questionnaire will be used to collect information about knowledge of healthy foods	baseline, 1 month
Secondary	Change in nutritional food intake behaviours	An investigator created questionnaire will be used to collect information about nutritional food intake behaviours	baseline, 1 month
Secondary	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
Secondary	Change in fasting blood glucose level	Participants diagnosed with diabetes will use a home glucometer to measure fasting blood glucose levels	baseline, 1 month
Secondary	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