- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433484
Heart-Healthy Lenoir Lifestyle Study
Community-Based Lifestyle Intervention to Reduce CVD Risk & Disparities in Risk
Study Overview
Status
Conditions
Intervention / Treatment
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 one of two intervention formats, each with 4 contacts: individual counseling with at least one face-to-face visit and the rest face-to-face or by phone or 4 group sessions. The dietary intervention will focus on improving fat and carbohydrate quality. For fat intake, the goals include 2-4 servings per day of polyunsaturated fat primarily from plant sources and minimal intake of trans fat. For carbohydrate intake, the goals include increased intake of whole grains, fruits and vegetables, and beans and reduced consumption of refined carbohydrates. The physical activity intervention will primarily focus on walking with a goal of 7500 to 10,000 steps per day or, for those who do not wish to use a pedometer, 30 minutes of walking a day. Muscle strengthening activities will also be recommended. At the 4-6 month follow-up measures, those who wish to take part in a weight loss study may do so and those who do not will continue in a maintenance of lifestyle intervention.
The investigators anticipate approximately 200 participants will take part in the weight loss component of this study, which consists of a 6 month intensive weight loss intervention. Participants may choose from two intervention formats: 16 weekly group sessions or 5 group sessions and 10 phone counseling sessions. The weight loss goal will be 5% of body weight. At the conclusion of this program, those who lose at least 8 pounds and are willing to take part in a 1 year maintenance of weight loss intervention will be RANDOMIZED to one of two maintenance of weight loss programs. One maintenance arm will receive monthly telephone contacts for one year, while the other arm will receive bi-monthly phone contacts.
Follow-up measures for all participants will be at approximately 6, 12, 18, and 24 months.
Another related part of the project will use a systems approach to develop models integrating clinical and genomic data. Researchers have developed and tested an approach referred to as the SAMARA (Supporting A Multidisciplinary Approach to Research in Atherosclerosis) Project that applies recent, major advances in biomedical and computational sciences at UNC to develop a deeper understanding of human CVD. The Heart-Healthy Lenoir Project will expand studies into the community, using this methodology to: 1) determine the prevalence of genomic risk signatures in high-risk community populations using genome-wide Single Nucleotide Polymorphism (SNP) analysis; 2) develop novel genomic models incorporating high-risk features in this population; and 3) determine whether genomic signatures can be used to predict responsiveness to interventions that underlie CVD disparities. Participants who consent to this component of the project will have a blood specimen obtained at baseline.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Kinston, North Carolina, United States, 28501
- Heart Healthy Lenoir Project, Kinston Enterprise Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Maintenance of Weight Loss--Control
The control arm will receive bi-monthly telephone contacts during the one-year maintenance phase.
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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.
|
EXPERIMENTAL: Maintenance of Weight Loss--Experimental
The experimental arm will receive monthly telephone contacts for one year during the maintenance phase.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cohort study: fruit and vegetable intake at 6 months
Time Frame: 6 months
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Fruit and vegetable intake will be measured by the Block fruit and vegetable sceener and by blood carotenoids
|
6 months
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Embedded randomized trial: maintenance of weight loss
Time Frame: 1 year after maintenance of weight loss trial begins
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Weight will be measured by electronic scale
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1 year after maintenance of weight loss trial begins
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: 6m, 12m, 18m, 24 m
|
Measured by questionnaire and pedometer
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6m, 12m, 18m, 24 m
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Blood pressure
Time Frame: 6, 12, 18, 24 months
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measured by automated device
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6, 12, 18, 24 months
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Blood lipids
Time Frame: 12, 24 months
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total and HDL cholesterol measured by commercial lab
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12, 24 months
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A1c
Time Frame: 6, 12, 24 months
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measured by commercial lab
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6, 12, 24 months
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Fruit and vegetable intake at 6 months
Time Frame: 12, 18, and 24 months
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Measured by Block fruit and vegetable screener
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12, 18, and 24 months
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Weight
Time Frame: 6, 12, 18, 24
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Measured by electronic scale
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6, 12, 18, 24
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Health related quality of life
Time Frame: 6, 12, 24 months
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SF-12 instrument
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6, 12, 24 months
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Genomic predictors of lifestyle change
Time Frame: 6-, 12-, 18- and 24-month follow-up
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A systems approach to developing genomic models integrating clinical and genomic data.
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6-, 12-, 18- and 24-month follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: Thomas C. Keyserling, MD, MPH, UNC-Chapel Hill
Publications and helpful links
General Publications
- 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.
- Keyserling 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-0395LS
- P50HL105184 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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