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Heart Health Study in Washington D.C. to Develop a Community-Based Behavioral Weight Loss Intervention

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ClinicalTrials.gov Identifier: NCT01927783
Recruitment Status : Recruiting
First Posted : August 23, 2013
Last Update Posted : January 9, 2023
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:


- Past studies suggest that the best way to improve heart health in the Black community is through community-based programs. Researchers will partner with DC community leaders. They will collect information about the health and health needs of people in mostly Black churches in DC. They will study things that affect heart health, like diabetes, blood pressure, cholesterol, and weight. They will also study how technology can keep track of activities and health. The information will show the health needs of this church-based community.


- To create an intervention for future programs to improve heart health in African-American churches in Washington, DC.


- Adults ages 19 to 85 who attend one of the study churches.


  • Participants will visit their church for a 4-hour health exam. They will have their blood pressure and body measurements taken. They will have a drop of blood taken from their finger with a small needle. This blood will be tested for blood sugar and cholesterol. Participants will be given the results of these tests.
  • Participants will answer questions about their health.
  • All participants will be given an activity monitor to wear for 1 month. The activity monitor is worn around the wrist. Some participants will also receive an activity monitor that is worn around the waist. Participants will be given instructions on how to wear the activity monitors and follow the results on a website.
  • At the end of 1 month, participants will return one device (they can keep the other). They may receive a gift card for completing the study.

Condition or disease
Cardiovascular Disease Obesity

Detailed Description:
Obesity leads to an increased risk of cardiovascular risk factors and death from cardiovascular disease. Therefore, interventions that slow or reverse the obesity epidemic are essential. Community-based interventions can reach those most at risk for obesity and obesity-related cardiovascular risk factors. Interventions based on community-based participatory research (CBPR) principles develop in collaboration with community partners, allowing an intervention's components to be tailored to the unique needs of the community members. To remain consistent with CBPR principles, a community assessment is necessary to understand the needs of the target population. Therefore, we propose a cardiovascular health screening and needs assessment of a sample population from predominantly African-American churches in Wards 5, 7, and 8. These are wards in Washington D.C. where obesity prevalence is highest and resources for physical activity and healthy nutrition are most limited. The screening will involve measuring cardiovascular health factors such as body mass index (BMI), physical activity, dietary intake, total cholesterol, blood pressure, fasting plasma glucose, and cigarette smoking. Based on American Heart Association-established goals, cardiovascular health factors can be defined as ideal, intermediate, or poor, depending on control of risk factors and lifestyle behaviors. In this protocol, we will determine the prevalence of ideal, intermediate, and poor cardiovascular health factors within the church-based population. We hypothesize that the percentage of the church-based population that meets ideal criteria for each of the cardiovascular health factors will be lower than the percentage meeting intermediate and poor criteria for the cardiovascular health factors. In addition, we will evaluate the use of handheld technology for objectively measuring physical activity and the use of web-based technology for monitoring cardiovascular health factors within the population. We will also evaluate social determinants of health, particularly psychosocial and environmental factors that might hinder weight loss. Finally, we will establish a community advisory board to consult on the planning and implementation of the assessment, and the interpretation and dissemination of study findings. The results of this community-based, cardiovascular health and needs assessment will inform the design and implementation of a future community-based behavioral weight loss intervention.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Cardiovascular Health and Needs Assessment in Washington D.C. - Development of a Community-Based Behavioral Weight Loss Intervention
Actual Study Start Date : February 8, 2014
Estimated Primary Completion Date : November 20, 2023

Resource links provided by the National Library of Medicine

Group 1
Healthy Volunteer
Group 2
Focus Group- Neighborhood and Physical Activity
Group 3
Focus Group
Group 4
Focus Group- Mobile App
Group 5
Consent for Cooking Survey Focus Group
Group 6
Community Organization Survey focus Group

Primary Outcome Measures :
  1. estimate CVD risk factors in Ward 5,7,8 [ Time Frame: ongoing ]
    data will inform the design and implementation of a behavioral weight-loss intervention within the faith-based community immediately following this study

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The purpose of this study is to evaluate cardiovascular health factors, psychosocial factors, cultural norms, and neighborhood environment characteristics in the predominantly African- American church-based population in Wards 5, 7, and 8 in Washington D.C.

Individuals eligible for this protocol are aged 19 - 85 years, attend one of the participating churches, and are able to provide informed consent independently. Eligible participants should also speak and read English at the 8th grade level.


Women in their second or third trimester of pregnancy at the time of enrollment will be excluded from the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927783

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Contact: Marie Marah, R.N. (301) 640-1701 marie.marah@nih.gov
Contact: Tiffany M Powell-Wiley, M.D. (301) 594-3735 powelltm2@mail.nih.gov

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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Tiffany M Powell-Wiley, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01927783    
Other Study ID Numbers: 130183
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: October 26, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .It is not yet known if there will be a plan to make IPD available

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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) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Cardiovascular Disease
Natural History
Additional relevant MeSH terms:
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Cardiovascular Diseases
Weight Loss
Body Weight
Body Weight Changes