Cardiovascular DiseaseNCT01927783
Heart Health Study in Washington D.C. to Develop a Community-Based Behavioral Weight Loss Intervention
An observational study of Cardiovascular Disease and Obesity, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: 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. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Obesity
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2014to 20 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This observational study will may involve cardiovascular health factor screening, administration of a survey, and evaluating usage of handheld and web-based technology related to physical activity, dietary intake, and cardiovascular health for one-month intervals through the duration of the study (for a maximum of 6 months) for a convenience sample of participants recruited from churches in Wards 5, 7, or 8 in Washington D.C and in neighboring Prince George s County.
Who may be able to join
- Individuals eligible for this protocol are aged 19 - 85 years, have attended or visited any church or faith-based organization in DC, Maryland, or Virginia, and are able to provide informed consent independently. Eligible participants should also speak and read English at the 8th grade level.
Who cannot join
- Women in their second or third trimester of pregnancy at the time of enrollment will be excluded from the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Cardiovascular Health and Needs Assessment in Washington D.C. - Development of a Community-Based Behavioral Weight Loss Intervention
Background:
- 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 church-based communities or faith-based organizations.
Read more
Objectives:
- The primary objective of this study is to estimate the percentage of the population that meet ideal, intermediate, and poor criteria for each of the cardiovascular health factors (BMI, physical activity, dietary intake, blood pressure, total cholesterol, fasting plasma glucose, and cigarette smoking) in churches or faith-based organizations in the DMV area. This data will inform the design and implementation of a behavioral weight-loss intervention within the faith-based community immediately following this study.
The secondary objectives are to: 1) evaluate usage of handheld devices for objectively measuring physical activity and dietary intake; 2) evaluate usage of web-based technology for monitoring cardiovascular health markers, including dietary intake; 3) examine referral methods for untreated hypertension, diabetes, and hypercholesterolemia; 4) compare lifestyle behaviors across levels of psychosocial factors, cultural norms, and neighborhood environment factors; and 5) formalize a community advisory board involved in the implementation of the health screening and needs assessment program and a future behavioral weight-loss intervention.
Eligibility:
- Adults ages 19 to 85 who attend one of the study churches.
Design:
- 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.
Read the 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 churches or faith-based organizations in DC, Maryland, and Virginia 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 or faith-based organization population. We hypothesize that the percentage of the church or faith-based organization 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.
- Conditions
- Cardiovascular Disease, Obesity
- Keywords
- Cardiovascular Disease, Obesity, Natural History
- Medical subject headings
- Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate CVD risk factors in Ward 5,7,8
data will inform the design and implementation of a behavioral weight-loss intervention within the faith-based community immediately following this study
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study start8 Feb 2014
- Primary completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tiffany M Powell-Wiley, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927783
- Sponsor's protocol ID
- 130183
- Other IDs
- 13-H-0183
- Status last verified
- 3 Jun 2026
- First submitted
- 20 Aug 2013
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Publications
Claudel SE, Tamura K, Troendle J, Andrews MR, Ceasar JN, Mitchell VM, Vijayakumar N, Powell-Wiley TM. Comparing Methods to Identify Wear-Time Intervals for Physical Activity With the Fitbit Charge 2. J Aging Phys Act. 2021 Jun 1;29(3):529-535. doi: 10.1123/japa.2020-0059. Epub 2020 Dec 16.
PubMed 33326935Fowler LA, Yingling LR, Brooks AT, Wallen GR, Peters-Lawrence M, McClurkin M, Wiley KL Jr, Mitchell VM, Johnson TD, Curry KE, Johnson AA, Graham AP, Graham LA, Powell-Wiley TM. Digital Food Records in Community-Based Interventions: Mixed-Methods Pilot Study. JMIR Mhealth Uhealth. 2018 Jul 17;6(7):e160. doi: 10.2196/mhealth.9729.
PubMed 30021705Yingling LR, Brooks AT, Wallen GR, Peters-Lawrence M, McClurkin M, Cooper-McCann R, Wiley KL Jr, Mitchell V, Saygbe JN, Johnson TD, Curry RK, Johnson AA, Graham AP, Graham LA, Powell-Wiley TM. Community Engagement to Optimize the Use of Web-Based and Wearable Technology in a Cardiovascular Health and Needs Assessment Study: A Mixed Methods Approach. JMIR Mhealth Uhealth. 2016 Apr 25;4(2):e38. doi: 10.2196/mhealth.4489.
PubMed 27113680