Status:
COMPLETED
Heart-Healthy Lenoir Lifestyle Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Disease
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to reduce cardiovascular disease (CVD) risk and disparities in risk by improving lifestyle factors which underlie the development of CVD. The first steps will involve conducting a comp...
Detailed Description
The lifestyle intervention will enroll 350 participants. The initial lifestyle component of this study, which lasts for 4-6 months, will be provided to all participants. Participants may chose from on...
Eligibility Criteria
Inclusion
- 18 years or older
- live in Lenoir County or a neighboring county in Eastern North Carolina
- anyone enrolled in the Lifestyle study is eligible to participate in the genomics component of the project.
Exclusion
- non-English speaking
- treatment of psychosis
- alcohol or substance abuse within the two last years
- history of malignancy, other than non-melanoma skin cancer, unless surgically cured \> 5 years ago or in remission/well treated and not likely to have a negative effect on the patient's health over the next 2 years
- estimated creatinine clearance less than 30 ml/min
- lack of access to phone
- advanced dementia
- participants who have been diagnosed with a myocardial infarction within the past three months will be excluded from the study if they are unable to obtain written medical clearance from their clinician to participate in the study
- Additional Exclusion Criteria - Weight Loss Intervention:
- the investigators will not invite pregnant women to take part in the weight loss study.
- if a woman becomes pregnant while taking part in this part of the study, we will withdraw her from the weight loss study and invite her to continue in the lifestyle study.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT01433484
Start Date
September 1 2011
End Date
October 1 2014
Last Update
November 20 2017
Active Locations (1)
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1
Heart Healthy Lenoir Project, Kinston Enterprise Center
Kinston, North Carolina, United States, 28501