Cardiac HealthNCT04509206
Virtual Teaching Kitchen
A study testing Nutritional education in people with Cardiac Health and Metabolic Syndrome, run by Boston University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Cardiac Health, Metabolic Syndrome
- What is being tested?
- Nutritional education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 13 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiac Health, Metabolic Syndrome
- Being tested
- Nutritional education
- Keywords
- virtual nutritional education, teaching kitchen, food insecurity, zoom media
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional educationBehavioural
The curriculum for the four classes include understanding MyPlate guidelines, learn basic knife skills, meal prep, and plan, home farming and no-cook cooking.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutritional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
recruitment rates
based on number of people invited to participate, number recruited and consented and number attended
Measured: 12 months
retention rates
based on attendance at each virtual educational session
Measured: 12 months
facilitators for nutritional education
information will be obtained through qualitative interviews
Measured: 12 months
barriers to nutritional education
information will be obtained through qualitative interviews
Measured: 12 months
Secondary outcomes (5)
knowledge of healthy foods
through qualitative interview
Measured: 12 months
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.
Measured: baseline, up to 6 months
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.
Measured: baseline, up to 6 months
change in hemoglobin A1c
Baseline will be extracted from the chart and 6 month will be extracted from the chart if available
Measured: baseline, 6 months
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.
Measured: baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start28 Sep 2020
- Primary completion28 Jul 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac HealthStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi M Hamburg, MD, Principal investigator, Dept of Cardiology, BU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509206
- Sponsor's protocol ID
- H-39597
- Status last verified
- Oct 2021
- First submitted
- 7 Aug 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Nutritional Education Delivered Through a Hospital Teaching Kitchen : a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT04509206
- Acronym / sponsor ID
- H-39597
- Conditions
- Cardiac Health, Metabolic Syndrome
- Keywords
- virtual nutritional education, teaching kitchen, food insecurity, zoom media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nutritional educationSubjects 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional educationThe curriculum for the four classes include understanding MyPlate guidelines, learn basic knife skills, meal prep, and plan, home farming and no-cook cooking. | Behavioural | Intervention |
Primary outcome
recruitment rates
Time frame: 12 months
based on number of people invited to participate, number recruited and consented and number attended
retention rates
Time frame: 12 months
based on attendance at each virtual educational session
facilitators for nutritional education
Time frame: 12 months
information will be obtained through qualitative interviews
barriers to nutritional education
Time frame: 12 months
information will be obtained through qualitative interviews
5 secondary outcomes
knowledge of healthy foods
Time frame: 12 months
change in blood pressure (BP)
Time frame: baseline, up to 6 months
change in blood glucose
Time frame: baseline, up to 6 months
change in hemoglobin A1c
Time frame: baseline, 6 months
change in weight
Time frame: baseline, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Cardiac Health
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Body-Based and Mind-Based Regulation in Overweight and Obese Women
Overweight and/or Obesity
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi M Hamburg, MD principal investigator
Dept of Cardiology, BU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional education in people with Cardiac Health and Metabolic Syndrome, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recruitment rates (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.