Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04509206
Other study ID # H-39597
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2020
Est. completion date August 13, 2021

Study information

Verified date October 2021
Source Boston University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date August 13, 2021
Est. primary completion date July 28, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary recruitment rates based on number of people invited to participate, number recruited and consented and number attended 12 months
Primary retention rates based on attendance at each virtual educational session 12 months
Primary facilitators for nutritional education information will be obtained through qualitative interviews 12 months
Primary barriers to nutritional education information will be obtained through qualitative interviews 12 months
Secondary knowledge of healthy foods through qualitative interview 12 months
Secondary change in blood pressure (BP) 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. baseline, up to 6 months
Secondary change in blood glucose 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. baseline, up to 6 months
Secondary change in hemoglobin A1c Baseline will be extracted from the chart and 6 month will be extracted from the chart if available baseline, 6 months
Secondary change in weight 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
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A