We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified November 24, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01927783
First Posted: August 23, 2013
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
August 20, 2013
August 23, 2013
November 28, 2017
August 20, 2013
September 30, 2018   (Final data collection date for primary outcome measure)
Prevalence of ideal, intermediate, and poor levels of each of the cardiovascular health factors in a sample population from predominantly African-American churches in Wards 5, 7, and 8 of Washington D.C. [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01927783 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Heart Health Study in Washington D.C. to Develop a Community-Based Behavioral Weight Loss Intervention
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 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.
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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
  • Cardiovascular Disease
  • Obesity
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 30, 2018
September 30, 2018   (Final data collection date for primary outcome measure)
  • 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.

Sexes Eligible for Study: All
19 Years to 85 Years   (Adult, Senior)
Yes
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
United States
 
 
NCT01927783
130183
13-H-0183
Not Provided
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: Tiffany M Powell-Wiley, M.D. National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
November 24, 2017