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NCT Number: NCT04305431

Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diet Cardiovascular Diseases Cooking Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • FIRST PHASE:

A sample of AA adults (n= 20) living in Wards 7 or 8 of Washington, D.C. will be recruited for this phase.

Inclusion criteria

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
  • elevated cholesterol
  • clinical hypertension or prehypertension
  • prediabetes
  • elevated fasting glucose level on laboratory report
  • current smoker or prior (within the past 12 months) smoker.

Exclusion criteria

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:

A sample of AA adults (n= 35) living in Wards 7 or 8 of Washington, D.C. will be recruited for this phase.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Cooking Intervention

Behavioral

90-minute culinary education sessions.

Primary outcomes

  1. Feasibility Measures

    Time frame: 26 weeks

    Recruitment and retention/attrition Attendance/Dosage Participant burden Implementation- treatment fidelity; measures of home cooking behavior

  2. 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

Secondary outcomes

  1. Second Phase Secondary Outcome

    Time frame: 18 weeks

    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

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Official study title

Exploring a Dietary Behavior Intervention in African-Americans at Risk for Cardiovascular Disease: A Community Acceptability and Feasibility Study

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Mar 12, 2020
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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