Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease

Sponsor
National Institutes of Health Clinical Center (CC) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04305431
Collaborator
(none)
50
1
1
41.2
1.2

Study Details

Study Description

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.

...

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cooking Intervention
N/A

Detailed Description

Disparities in cardiovascular disease (CVD) morbidity and mortality among African-Americans (AAs) persist despite advances in risk factor identification and evidence-based management strategies. Studies suggest risk factor reduction, such as obesity treatment, positively attenuates the mortality disparity between AAs and other racial/ethnic groups. Closing the CVD disparity gap may require attention to more proximal causes of CVD that lower risk factors, including cardiovascular health behaviors such as dietary intake and physical activity. Cardiovascular-related health behaviors are directly correlated with socioeconomic status, and thus, populations with lower socioeconomic status are more likely to experience disparate health outcomes. One particularly important health behavior known to reduce CVD risk, but also with culturally specific influences and dynamics, is dietary behavior. Factors such as food access, decreased nutritional awareness, and cultural preference are significant contributors to dietary behaviors and lower dietary quality. Given that lower dietary quality is reported among AAs, it is important to understand how these other factors may influence AA dietary behaviors and decisions. Among dietary behaviors, cooking behavior is identified as an important way to lower sodium intake and daily calories as well as to improve fiber intake. Cooking activity among AAs has been reported as lower than other racial/ethnic groups. Determinants of cooking among AAs have not been fully explored in the literature. Qualitative studies suggest demographic variables related to employment, number of family members, as well as psychosocial variables related to social support and norms may have a role. Limited cooking intervention studies, which have included AAs, suggest improved outcomes related to diet, including DASH scores, but impact on home cooking behavior during or after a cooking intervention is not known, because self-reported confidence and/or dietary quality variables have been the primary outcomes reported. Furthermore, outcomes of these studies and suggested related factors to home cooking have not been measured against feasibility measures for delivering the intervention in a community setting.

This study will occur in two phases: First phase consists of a focus group discussion on dietary behaviors with community members and the second phase consists of the dietary behavior intervention delivered in a community setting, clinical examination, survey and biomarker data collection.The primary objective of this study is to 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.

Secondary objectives are to explore relationships between feasibility measures, especially in relation to participant burden, cooking frequency, facilitators and barriers suggested from current literature as related to cooking at home. These include 1) psychosocial factors, social support, social network diversity, perceived stress of cooking behaviors, 2) lifestyle behaviors: sleep, physical activity, 3) built environment factors.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Exploring a Dietary Behavior Intervention in African-Americans at Risk for Cardiovascular Disease: A Community Acceptability and Feasibility Study
Actual Study Start Date :
Feb 25, 2021
Anticipated Primary Completion Date :
Nov 5, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1/All Subjects

Second phase participants

Behavioral: Cooking Intervention
90-minute culinary education sessions.

Outcome Measures

Primary Outcome Measures

  1. Feasibility Measures [26 weeks]

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

  2. Facilitators and Barriers [26 weeks]

    Cooking diaries Cooking Self-Efficacy Scale D.C. CHOC Cooking Survey Cooking and Food Provisioning Action Scale AMPS (cooking skill) score

Secondary Outcome Measures

  1. Second Phase Secondary Outcome [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  • 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= 30) 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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

Sponsors and Collaborators

  • National Institutes of Health Clinical Center (CC)

Investigators

  • Principal Investigator: Nicole M Farmer, M.D., National Institutes of Health Clinical Center (CC)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT04305431
Other Study ID Numbers:
  • 200036
  • 20-CC-0036
First Posted:
Mar 12, 2020
Last Update Posted:
Aug 19, 2022
Last Verified:
Jul 5, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Institutes of Health Clinical Center (CC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022