NCT04305431

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. ...

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Feb 2021Aug 2027

First Submitted

Initial submission to the registry

March 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 5, 2026

Status Verified

February 2, 2026

Enrollment Period

5.8 years

First QC Date

March 11, 2020

Last Update Submit

May 2, 2026

Conditions

DietCooking

Keywords

DiabetesHeart DiseaseDietary BehaviorNutrition

Outcome Measures

Primary Outcomes (2)

  • Feasibility Measures

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

    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

    26 weeks

Secondary Outcomes (1)

  • Second Phase Secondary Outcome

    18 weeks

Study Arms (1)

1/All Subjects

EXPERIMENTAL

Second phase participants

Behavioral: Cooking Intervention

Interventions

Cooking InterventionBEHAVIORAL

90-minute culinary education sessions.

1/All Subjects

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36550396DERIVED

  • Farmer 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.

    PMID: 33088581DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusHeart Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular Diseases

Study Officials

  • Nicole M Farmer, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie L Wildridge, R.N.

CONTACT

(240) 927-2603wildridgesl@mail.nih.gov

Nicole M Farmer, M.D.

CONTACT

(301) 412-4054nicole.farmer@nih.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 12, 2020

Study Start

February 25, 2021

Primary Completion (Estimated)

December 19, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-02-02

Locations

US(1)