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

• ClinicalTrials.gov Identifier: NCT01927783
• Recruitment Status: Recruiting
• First Posted: August 23, 2013
• Last Update Posted: September 16, 2019
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description

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 this church-based community.

Objectives:

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

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.

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.

Study Design

• 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: December 1, 2019
• Estimated Study Completion Date: September 24, 2020

Groups and Cohorts

Group/Cohort
1; 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.

Outcome Measures

Primary Outcome Measures :

1. estimate CVD risk factors in Ward 5,7,8 [ Time Frame: 12 months ]

Eligibility Criteria

• 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.@@@

Criteria

• INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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

Contacts and Locations

Contacts

Contact: Valerie Morales-Mitchelll; (301) 827-4981; valerie.mitchell@nih.gov

Contact: Tiffany M Powell-Wiley, M.D.; (301) 594-3735; powelltm2@mail.nih.gov

Locations

United States, Maryland

National Institutes of Health Clinical Center, 9000 Rockville Pike; Recruiting

Bethesda, Maryland, United States, 20892

Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Tiffany M Powell-Wiley, M.D.; National Heart, Lung, and Blood Institute (NHLBI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

Publications:

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. Review. Erratum in: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad. Circulation. 2013 Jun 11;127(23):e841.

Berrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ, Moore SC, Tobias GS, Anton-Culver H, Freeman LB, Beeson WL, Clipp SL, English DR, Folsom AR, Freedman DM, Giles G, Hakansson N, Henderson KD, Hoffman-Bolton J, Hoppin JA, Koenig KL, Lee IM, Linet MS, Park Y, Pocobelli G, Schatzkin A, Sesso HD, Weiderpass E, Willcox BJ, Wolk A, Zeleniuch-Jacquotte A, Willett WC, Thun MJ. Body-mass index and mortality among 1.46 million white adults. N Engl J Med. 2010 Dec 2;363(23):2211-9. doi: 10.1056/NEJMoa1000367. Erratum in: N Engl J Med. 2011 Sep 1;365(9):869.

Boggs DA, Rosenberg L, Cozier YC, Wise LA, Coogan PF, Ruiz-Narvaez EA, Palmer JR. General and abdominal obesity and risk of death among black women. N Engl J Med. 2011 Sep 8;365(10):901-8. doi: 10.1056/NEJMoa1104119.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT01927783 History of Changes
• Other Study ID Numbers: 130183; 13-H-0183
• First Posted: August 23, 2013
• Last Update Posted: September 16, 2019
• Last Verified: June 17, 2019

• 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; Obesity

Additional relevant MeSH terms:

Weight Loss; Cardiovascular Diseases; Body Weight; Signs and Symptoms; Body Weight Changes