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Clinical Trials/NCT04305431
NCT04305431Active, not recruitingNot Applicable

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

National Institutes of Health Clinical Center (CC)1 site in 1 country43 target enrollmentStarted: February 25, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
43
Locations
1
Primary Endpoint
Feasibility Measures

Study Overview

Brief 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. 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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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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Arms & Interventions

1/All Subjects

Experimental

Second phase participants

Intervention: Cooking Intervention (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Second Phase Secondary Outcome(18 weeks)

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (1)

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