Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01927783 |
| Other study ID # |
130183 |
| Secondary ID |
13-H-0183 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 8, 2014 |
Study information
| Verified date |
May 30, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
Marie Marah, R.N. |
| Phone |
(301) 640-1701 |
| Email |
marie.marah[@]nih.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
