DietNCT04305431
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
A study testing Cooking Intervention in people with Diet and Cooking, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: The risk of heart disease among African Americans is still common despite a greater understanding of the disease and better approaches to managing it. Healthy cooking and eating patterns can help reduce the risk of heart disease. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- Cooking Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Self-identified AA adults (defined as age greater than or equal to 18)
- Live in Wards 7 or 8 in Washington, D.C.
- At least one self-reported risk factor for CV disease known by participant or told to participant by a clinician within the last 12 months. Specific risk factors are:
- overweight or obese (self-reported height and weight compute to BMI if needed greater than or equal to 25)
- elevated waist to hip ratio
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- elevated cholesterol
- clinical hypertension or prehypertension
- prediabetes
- elevated fasting glucose level on laboratory report
- current smoker or prior (within the past 12 months) smoker.
- English-speaking
- Self-identified AA adults (defined as age greater than or equal to 18)
- Who live in Wards 7 or 8 in Washington, D.C.
- At least one self-reported risk factor for CV disease known by participant or told to participant by a clinician within the last 12 months. Specific risk factors are:
- overweight or obese (self-reported height and weight compute to BMI if needed >= 25)
- elevated waist to hip ratio
- elevated cholesterol
- clinical hypertension or prehypertension
- prediabetes
- elevated fasting glucose level on laboratory report
- current smoker or prior (within the past 12 months) smoker.
- Not pregnant at the time of screening and enrollment.
- Willing to not attend or enroll in another cooking/culinary education program or class during participation in this study
- Not enrolled currently or in the prior 12 months (at time of recruitment) in another ongoing cooking/culinary education program or class
Who cannot join
- Under the age of 18
- Do not live in Wards 7 or 8 in Washington, D.C.
- No risk factors for CVD
- Or adults not of AA descent (self-identified)
- Non-English speaking
- SECOND PHASE:
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- A sample of AA adults (n= 35) living in Wards 7 or 8 of Washington, D.C. will be recruited for this phase.
- AAs who are not age greater than or equal to 18
- AA Adults not living in Wards 7 or 8 in Washington, D.C.
- AA Adults living in the same household as another participant
- AA adults without at least one risk factor for CVD
- Or adults not of AA descent
- Non-English speaking
- Those enrolled currently or in the prior 12 months at time of recruitment in another ongoing cooking/culinary education program
- Those not willing to not attend or enroll in another cooking/culinary education program or class during participation in this study
- If individuals become pregnant during their participation, they can continue to participate if they want to. The pregnant participant will not undergo DEXA scanning procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Exploring a Dietary Behavior Intervention in African-Americans at Risk for Cardiovascular Disease: A Community Acceptability and Feasibility Study
Background:
The risk of heart disease among African Americans is still common despite a greater understanding of the disease and better approaches to managing it. Healthy cooking and eating patterns can help reduce the risk of heart disease. But things like access to grocery stores and knowledge of good nutrition can affect these healthy patterns. Researchers want to see if community-based programs can help.
Read more
Objective:
To learn about the cooking behaviors of African American adults at risk for heart disease. Also, to see if a community-based cooking intervention will affect home-cooking behaviors.
Eligibility:
African American adults 18 and older who live in Wards 7 and 8 of Washington, D.C., and have at least one self-reported risk factor for heart disease
Design:
Phase I participants will complete a survey. It asks about their medical history, lifestyle, stress level, and eating habits. They will take part in a focus group. During this, they will talk about what they eat and what foods are available to them. Participation lasts 1 day for 3 hours at Pennsylvania Avenue Baptist Church in Washington, D.C.
Phase II participants will go to shared cooking events at Pennsylvania Avenue Baptist Church. These will be held once a week for 6 weeks. They will be led by a trained chef. Participants will visit the NIH Clinical Center 3 times. Transportation will be provided if they need it. They will have physical exams and have blood drawn. They will be interviewed and complete questionnaires. A dietician will review the food they eat. An occupational therapist will assess their cooking skills. They will keep a daily cooking journal. Participation lasts 18 weeks.
...
Read the detailed description
Study Description: Explore feasibility measures, facilitators and barriers related to cooking and cooking frequency among an AA adult population at risk for CVD following participation in a cooking intervention.
Objectives:
First Phase Primary Objective:
Identify facilitators and barriers to cooking frequency and assess feasibility of a cooking intervention among AA adults living in a food desert community.
Assess feasibility of a cooking intervention among AA adults living in a food desert community.
First Phase Secondary Objectives:
Explore the relationship between cooking frequency, facilitators, and barriers with individual, social environment and built environment factors, as suggested from qualitative research and cooking intervention studies.
Second Phase Primary Objectives:
Identify facilitators and barriers to cooking, and cooking frequency among AA adults living in a food desert community who participate in a cooking intervention.
Determine feasibility measures of the intervention associated with cooking frequency, facilitators, or barriers for participants who participate in a cooking intervention.
Second Phase Secondary Objectives:
Explore the relationship between feasibility measures, cooking frequency, facilitators and barriers with individual factors, social environment and built environment factors related to cooking at home as a result of participating in a cooking intervention
Explore the relationship between feasibility measures, cooking frequency, facilitators and barriers to dietary quality, as determined by evaluation of food dietary records, Mediterranean Diet Score, Healthy Eating Index scores for participants who participate in a cooking intervention.
Explore the relationship between feasibility measures, cooking frequency, facilitators and barriers with CVD biomarkers, as measured by CVD related laboratory studies, and anthropometric measurements.
Endpoints:
Primary Endpoint:
Identify and measure barriers, facilitators, cooking frequency, cooking skills in AA participants: in context of feasibility risibility measures for the cooking intervention.
Secondary Endpoints:
Explore and measure diet quality and CVD biomarkers.
- Being tested
- Cooking Intervention
- Keywords
- Diabetes, Heart Disease, Dietary Behavior, Nutrition
- Medical subject headings
- Diabetes Mellitus, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking InterventionBehavioural
90-minute culinary education sessions.
| Study group | Role | What they receive |
|---|---|---|
| 1/All Subjects | Experimental | Second phase participants Receives: Behavioral: Cooking Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Measures
Recruitment and retention/attrition Attendance/Dosage Participant burden Implementation- treatment fidelity; measures of home cooking behavior
Measured: 26 weeks
Facilitators and Barriers
Cooking diaries Cooking Self-Efficacy Scale D.C. CHOC Cooking Survey Cooking and Food Provisioning Action Scale AMPS (cooking skill) score
Measured: 26 weeks
Secondary outcomes (1)
Second Phase Secondary Outcome
Social Network Index HPLP-II Perceived Stress Scale MESA Neighborhood Healthy Food Availability Scale Perceptions of Neighborhood Food Retail Outlets Neighborhood Satisfaction Food purchasing practices Self-rated Health Pittsburgh Sleep Quality Assessment International Physical Activity Questionnaire-Short Form Food Away from Home Purchasing Frequency Family Meals Eaten Together Grocery receipts CVD related laboratory biomarkers Antropometric mesurements
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start25 Feb 2021
- Primary completion19 Dec 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DietStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nicole M Farmer, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305431
- Sponsor's protocol ID
- 200036
- Other IDs
- 20-CC-0036
- Status last verified
- 17 Sep 2026
- First submitted
- 11 Mar 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farmer N, Tuason RT, Kazmi N, Flynn S, Mitchell V, Middleton K, Cox R, Franklin K, Gordon T, Baginski A, Wallen GR. Going virtual during the COVID-19 pandemic: adaptation of a mixed-methods dietary behavior study within a community-based participatory research study of African-American adults at risk for cardiovascular disease. BMC Med Res Methodol. 2022 Dec 22;22(1):330. doi: 10.1186/s12874-022-01806-3.
PubMed 36550396Farmer N, Powell-Wiley TM, Middleton KR, Roberson B, Flynn S, Brooks AT, Kazmi N, Mitchell V, Collins B, Hingst R, Swan L, Yang S, Kakar S, Harlan T, Wallen GR. A community feasibility study of a cooking behavior intervention in African-American adults at risk for cardiovascular disease: DC COOKS (DC Community Organizing for Optimal culinary Knowledge Study) with Heart. Pilot Feasibility Stud. 2020 Oct 19;6:158. doi: 10.1186/s40814-020-00697-9. eCollection 2020.
PubMed 33088581
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring a Dietary Behavior Intervention in African-Americans at Risk for Cardiovascular Disease: A Community Acceptability and Feasibility Study
- ClinicalTrials.gov ID
- NCT04305431
- Acronym / sponsor ID
- 200036
- Keywords
- Diabetes, Heart Disease, Dietary Behavior, Nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 19 Dec 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 12 Mar 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.
Background:
The risk of heart disease among African Americans is still common despite a greater understanding of the disease and better approaches to managing it. Healthy cooking and eating patterns can help reduce the risk of heart disease. But things like access to grocery stores and knowledge of good nutrition can affect these healthy patterns. Researchers want to see if community-based programs can help.
Objective:
To learn about the cooking behaviors of African American adults at risk for heart disease. Also, to see if a community-based cooking intervention will affect home-cooking behaviors.
Eligibility:
African American adults 18 and older who live in Wards 7 and 8 of Washington, D.C., and have at least one self-reported risk factor for heart disease
Design:
Phase I participants will complete a survey. It asks about their medical history, lifestyle, stress level, and eating habits. They will take part in a focus group. During this, they will talk about what they eat and what foods are available to them. Participation lasts 1 day for 3 hours at Pennsylvania Avenue Baptist Church in Washington, D.C.
Phase II participants will go to shared cooking events at Pennsylvania Avenue Baptist Church. These will be held once a week for 6 weeks. They will be led by a trained chef. Participants will visit the NIH Clinical Center 3 times. Transportation will be provided if they need it. They will have physical exams and have blood drawn. They will be interviewed and complete questionnaires. A dietician will review the food they eat. An occupational therapist will assess their cooking skills. They will keep a daily cooking journal. Participation lasts 18 weeks.
...
Detailed description
Study Description: Explore feasibility measures, facilitators and barriers related to cooking and cooking frequency among an AA adult population at risk for CVD following participation in a cooking intervention.
Objectives:
First Phase Primary Objective:
Identify facilitators and barriers to cooking frequency and assess feasibility of a cooking intervention among AA adults living in a food desert community.
Assess feasibility of a cooking intervention among AA adults living in a food desert community.
First Phase Secondary Objectives:
Explore the relationship between cooking frequency, facilitators, and barriers with individual, social environment and built environment factors, as suggested from qualitative research and cooking intervention studies.
Second Phase Primary Objectives:
Identify facilitators and barriers to cooking, and cooking frequency among AA adults living in a food desert community who participate in a cooking intervention.
Determine feasibility measures of the intervention associated with cooking frequency, facilitators, or barriers for participants who participate in a cooking intervention.
Second Phase Secondary Objectives:
Explore the relationship between feasibility measures, cooking frequency, facilitators and barriers with individual factors, social environment and built environment factors related to cooking at home as a result of participating in a cooking intervention
Explore the relationship between feasibility measures, cooking frequency, facilitators and barriers to dietary quality, as determined by evaluation of food dietary records, Mediterranean Diet Score, Healthy Eating Index scores for participants who participate in a cooking intervention.
Explore the relationship between feasibility measures, cooking frequency, facilitators and barriers with CVD biomarkers, as measured by CVD related laboratory studies, and anthropometric measurements.
Endpoints:
Primary Endpoint:
Identify and measure barriers, facilitators, cooking frequency, cooking skills in AA participants: in context of feasibility risibility measures for the cooking intervention.
Secondary Endpoints:
Explore and measure diet quality and CVD biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/All Subjects | Experimental | Behavioral: Cooking InterventionSecond phase participants |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- English-speaking
- Self-identified AA adults (defined as age greater than or equal to 18)
- Live in Wards 7 or 8 in Washington, D.C.
- At least one self-reported risk factor for CV disease known by participant or told to participant by a clinician within the last 12 months. Specific risk factors are:
- overweight or obese (self-reported height and weight compute to BMI if needed greater than or equal to 25)
Key exclusion criteria (16 listed)
- Under the age of 18
- Do not live in Wards 7 or 8 in Washington, D.C.
- No risk factors for CVD
- Or adults not of AA descent (self-identified)
- Non-English speaking
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 |
|---|---|---|
| Cooking Intervention90-minute culinary education sessions. | Behavioural | 1/All Subjects |
Primary outcome
Feasibility Measures
Time frame: 26 weeks
Recruitment and retention/attrition Attendance/Dosage Participant burden Implementation- treatment fidelity; measures of home cooking behavior
Facilitators and Barriers
Time frame: 26 weeks
Cooking diaries Cooking Self-Efficacy Scale D.C. CHOC Cooking Survey Cooking and Food Provisioning Action Scale AMPS (cooking skill) score
1 secondary outcome
Second Phase Secondary Outcome
Time frame: 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 36550396Farmer N, Tuason RT, Kazmi N, Flynn S, Mitchell V, Middleton K, Cox R, Franklin K, Gordon T, Baginski A, Wallen GR. Going virtual during the COVID-19 pandemic: adaptation of a mixed-methods dietary behavior study within a community-based participatory research study of African-American adults at risk for cardiovascular disease. BMC Med Res Methodol. 2022 Dec 22;22(1):330. doi: 10.1186/s12874-022-01806-3.
- Derived from this study: PubMed 33088581Farmer N, Powell-Wiley TM, Middleton KR, Roberson B, Flynn S, Brooks AT, Kazmi N, Mitchell V, Collins B, Hingst R, Swan L, Yang S, Kakar S, Harlan T, Wallen GR. A community feasibility study of a cooking behavior intervention in African-American adults at risk for cardiovascular disease: DC COOKS (DC Community Organizing for Optimal culinary Knowledge Study) with Heart. Pilot Feasibility Stud. 2020 Oct 19;6:158. doi: 10.1186/s40814-020-00697-9. eCollection 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Healthy Volunteers
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.
Nicole M Farmer, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking Intervention in people with Diet and Cooking, run by National Institutes of Health Clinical Center (CC) 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 25 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility Measures (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305431, which also lists 2 linked publications.
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 5 Nov 2026.