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

NCT01927783 | Recruiting

• 2 other identifiers: 13018313-H-0183
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Obesity

Keywords

Cardiovascular Disease; Obesity; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

  ongoing

Study Arms (6)

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

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 33326935 DERIVED

• Fowler 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.

  PMID: 30021705 DERIVED

• Yingling 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.

  PMID: 27113680 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiffany M Powell-Wiley, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Marah, R.N.

CONTACT

(301) 640-1701; marie.marah@nih.gov

Tiffany M Powell-Wiley, M.D.

CONTACT

(301) 594-3735; powelltm2@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: February 8, 2014
• Primary Completion (Estimated): December 20, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-03-20

Locations

US (1)