NCT04784338

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

March 2, 2021

Last Update Submit

August 21, 2021

Conditions

Metabolic SyndromeObesity

Keywords

Culinary medicineTeaching kitchensVirtual shared medical appointments (SMA)Mind body exercisesSocial Determinants of Health (SDoH)

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Change in knowledge of healthy foods

    baseline, 1 month

  • Change in nutritional food intake behaviours

    baseline, 1 month

  • Change in blood pressure

    baseline, 1 month

  • Change in fasting blood glucose level

    baseline, 1 month

  • Change in body mass index [BMI]

    baseline, 1 month

Study Arms (1)

Virtual shared teaching kitchen program

EXPERIMENTAL

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

Behavioral: Virtual shared medical visitBehavioral: Nutritional classes

Interventions

Virtual shared medical visitBEHAVIORAL

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

Virtual shared teaching kitchen program
Nutritional classesBEHAVIORAL

A cooking class done by the teaching kitchen demonstrating cooking skills

Virtual shared teaching kitchen program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ivania Rizo, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

August 1, 2021

Primary Completion

April 1, 2022

Study Completion

October 1, 2022

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share