Heart-Healthy Lenoir Lifestyle Study
Community-Based Lifestyle Intervention to Reduce CVD Risk & Disparities in Risk
2 other identifiers
interventional
339
1 country
1
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 comprehensive formative evaluation to assess individual, interpersonal, organizational, community, and policy factors relevant to CVD risk and risk reduction in Lenoir County. This will be followed by a community-based lifestyle intervention program designed to improve eating patterns, promote physical activity, and for those who are interested, support weight loss. A randomized trial comparing the effectiveness of two community based weight maintenance interventions will also be conducted. Community-wide policy and environmental change interventions will also be implemented to support the individual-level interventions, including partnerships with businesses to promote a healthy environment through innovative economic opportunities. In addition, this project will explore genetic factors associated with cardiovascular disease risk and treatment success.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 20, 2017
August 1, 2015
3.1 years
August 30, 2011
November 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cohort study: fruit and vegetable intake at 6 months
Fruit and vegetable intake will be measured by the Block fruit and vegetable sceener and by blood carotenoids
6 months
Embedded randomized trial: maintenance of weight loss
Weight will be measured by electronic scale
1 year after maintenance of weight loss trial begins
Secondary Outcomes (8)
Physical activity
6m, 12m, 18m, 24 m
Blood pressure
6, 12, 18, 24 months
Blood lipids
12, 24 months
A1c
6, 12, 24 months
Fruit and vegetable intake at 6 months
12, 18, and 24 months
- +3 more secondary outcomes
Study Arms (2)
Maintenance of Weight Loss--Control
ACTIVE COMPARATORThe control arm will receive bi-monthly telephone contacts during the one-year maintenance phase.
Maintenance of Weight Loss--Experimental
EXPERIMENTALThe experimental arm will receive monthly telephone contacts for one year during the maintenance phase.
Interventions
As the maintenance of weight loss randomized trial does not begin until a year after the start of this study, the intervention and control conditions are not yet specified. This will occur before randomization and this section will be updated before the first participant is randomized.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Healthy Lenoir Project, Kinston Enterprise Center
Kinston, North Carolina, 28501, United States
Related Publications (2)
Embree GG, Samuel-Hodge CD, Johnston LF, Garcia BA, Gizlice Z, Evenson KR, DeWalt DA, Ammerman AS, Keyserling TC. Successful long-term weight loss among participants with diabetes receiving an intervention promoting an adapted Mediterranean-style dietary pattern: the Heart Healthy Lenoir Project. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000339. doi: 10.1136/bmjdrc-2016-000339. eCollection 2017.
PMID: 28405344DERIVEDKeyserling TC, Samuel-Hodge CD, Pitts SJ, Garcia BA, Johnston LF, Gizlice Z, Miller CL, Braxton DF, Evenson KR, Smith JC, Davis GB, Quenum EL, Elliott NT, Gross MD, Donahue KE, Halladay JR, Ammerman AS. A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project. BMC Public Health. 2016 Aug 5;16:732. doi: 10.1186/s12889-016-3370-9.
PMID: 27495295DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas C. Keyserling, MD, MPH
UNC-Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2011
First Posted
September 14, 2011
Study Start
September 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 20, 2017
Record last verified: 2015-08