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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-CC-0036

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

No

Population Exclusion(s)

White;
Native Hawaiian/Pacific Islander;
Hispanic or Latino;
Asian;
American Indian or Alaskan Native;
Non-English Speaking;
Children

Keywords

Diabetes;
Heart Disease;
Dietary Behavior;
Nutrition

Recruitment Keyword(s)

None

Condition(s)

Diet;
Cooking

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Cooking Intervention

Supporting Site

NIH Clinical Center

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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Eligibility

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 (BMI 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.

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 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 or class

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 DXA scanning procedure.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Nicole M. Farmer, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 3C440
10 CENTER DR
BETHESDA MD 20892
(301) 412-4054
nicole.farmer@nih.gov

Stephanie L. Wildridge, R.N.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 2B07B4
10 CENTER DR
BETHESDA MD 20892
(240) 927-2603
wildridgesl@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04305431

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