NCT01927783 Heart Health Study in Washington D.C. to Develop a Community-Based Behavioral Weight Loss Intervention
| NCT ID | NCT01927783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Cardiovascular Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2014-02-08 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2014-02-08 with a primary completion date of 2026-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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. 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.
Eligibility Criteria
* INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: Women in their second or third trimester of pregnancy at the time of enrollment will be excluded from the protocol.
Contact & Investigator
Tiffany M Powell-Wiley, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT01927783 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 85 Years, studying Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01927783 currently recruiting?
Yes, NCT01927783 is actively recruiting participants. Contact the research team at marie.marah@nih.gov for enrollment information.
Where is the NCT01927783 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT01927783 clinical trial?
NCT01927783 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Tiffany M Powell-Wiley, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 200 participants.