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

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT01927783
Collaborator
(none)
200
1
105.4
1.9

Study Details

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 Intervention/Treatment Phase

    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
    Anticipated 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 :
    Feb 8, 2014
    Anticipated Primary Completion Date :
    Nov 20, 2022
    Anticipated Study Completion Date :
    Nov 20, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. estimate CVD risk factors in Ward 5,7,8 [ongoing]

      data will inform the design and implementation of a behavioral weight-loss intervention within the faith-based community immediately following this study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    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)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Heart, Lung, and Blood Institute (NHLBI)
    ClinicalTrials.gov Identifier:
    NCT01927783
    Other Study ID Numbers:
    • 130183
    • 13-H-0183
    First Posted:
    Aug 23, 2013
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jul 27, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022