NCT04509206

Brief Summary

A novel way of delivering nutritional education is through experiential learning in a teaching kitchen setting. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had improved cardiac health. Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity and its consequences. This includes a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established three-pronged approach places our institution in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population. Given the increasing focus on providing remote experiences to minimize contact and risk of infection with Sars-COV-2, the investigators are proposing a study where patients can benefit from nutritional education virtually. Patients with food insecurity and metabolic syndrome who utilize the food pantry will be invited to an educational program conducted on zoom. The program will be run by a registered dietician and chef who will deliver education virtually. Data will be collected using 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 program improves cardiac health in patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2021

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

August 7, 2020

Last Update Submit

October 2, 2021

Conditions

Keywords

virtual nutritional educationteaching kitchenfood insecurityzoom media

Outcome Measures

Primary Outcomes (4)

  • recruitment rates

    based on number of people invited to participate, number recruited and consented and number attended

    12 months

  • retention rates

    based on attendance at each virtual educational session

    12 months

  • facilitators for nutritional education

    information will be obtained through qualitative interviews

    12 months

  • barriers to nutritional education

    information will be obtained through qualitative interviews

    12 months

Secondary Outcomes (5)

  • knowledge of healthy foods

    12 months

  • change in blood pressure (BP)

    baseline, up to 6 months

  • change in blood glucose

    baseline, up to 6 months

  • change in hemoglobin A1c

    baseline, 6 months

  • change in weight

    baseline, up to 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Subjects will undergo four nutritional educational classes, lasting 1 hour long, conducted over a two month period. These classes will occur on zoom and subjects will be located in their home.

Behavioral: Nutritional education

Interventions

The curriculum for the four classes include understanding MyPlate guidelines, learn basic knife skills, meal prep, and plan, home farming and no-cook cooking.

Intervention

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Users of the food pantry
  • English speaking
  • Must have one of following on their EPIC problem list (Diabetes mellitus, obesity, hypertension, hyperlipidemia or obstructive sleep apnea)
  • Must have documented measured blood pressure, weight, height in the 12 months prior to the intervention.

You may not qualify if:

  • Patients with advanced dementia or uncontrolled psychiatric disease
  • Non-english speakers since education delivered in the pilot in English
  • Uncontrolled medical illness including 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

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Naomi M Hamburg, MD

    Dept of Cardiology, BU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Study Start

September 28, 2020

Primary Completion

July 28, 2021

Study Completion

August 13, 2021

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations