- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509206
Virtual Teaching Kitchen
A Virtual Nutritional Education Delivered Through a Hospital Teaching Kitchen : a Proof-of-concept Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
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The curriculum for the four classes include understanding MyPlate guidelines, learn basic knife skills, meal prep, and plan, home farming and no-cook cooking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
recruitment rates
Time Frame: 12 months
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based on number of people invited to participate, number recruited and consented and number attended
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12 months
|
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retention rates
Time Frame: 12 months
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based on attendance at each virtual educational session
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12 months
|
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facilitators for nutritional education
Time Frame: 12 months
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information will be obtained through qualitative interviews
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12 months
|
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barriers to nutritional education
Time Frame: 12 months
|
information will be obtained through qualitative interviews
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knowledge of healthy foods
Time Frame: 12 months
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through qualitative interview
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12 months
|
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change in blood pressure (BP)
Time Frame: baseline, up to 6 months
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Baseline BP will be extracted from medical chart.
Subjects will be provided with a home BP cuff.
BP measurements performed by the patient will be recorded on the BP app.
The 6 month follow BP will be extracted from the medical chart if available.
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baseline, up to 6 months
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change in blood glucose
Time Frame: baseline, up to 6 months
|
Baseline blood glucose will be extracted from medical chart.
Subjects will use their own glucometer to measure their blood glucose.
glucose measurements performed by the patient will be recorded on the glucometer.
The 6 month follow blood glucose will be extracted from the medical chart if available.
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baseline, up to 6 months
|
|
change in hemoglobin A1c
Time Frame: baseline, 6 months
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Baseline will be extracted from the chart and 6 month will be extracted from the chart if available
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baseline, 6 months
|
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change in weight
Time Frame: baseline, up to 6 months
|
Baseline weight will be extracted from medical chart.
Subjects will be provided with a home scale.
weight measurements performed by the patient will be recorded on the scale app.
The 6 month follow weight will be extracted from the medical chart if available.
|
baseline, up to 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naomi M Hamburg, MD, Dept of Cardiology, BU School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-39597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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