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Heart-Healthy Lenoir Lifestyle Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01433484
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : November 20, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE August 30, 2011
First Posted Date  ICMJE September 14, 2011
Last Update Posted Date November 20, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2011)
  • Cohort study: fruit and vegetable intake at 6 months [ Time Frame: 6 months ]
    Fruit and vegetable intake will be measured by the Block fruit and vegetable sceener and by blood carotenoids
  • Embedded randomized trial: maintenance of weight loss [ Time Frame: 1 year after maintenance of weight loss trial begins ]
    Weight will be measured by electronic scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2011)
  • Physical activity [ Time Frame: 6m, 12m, 18m, 24 m ]
    Measured by questionnaire and pedometer
  • Blood pressure [ Time Frame: 6, 12, 18, 24 months ]
    measured by automated device
  • Blood lipids [ Time Frame: 12, 24 months ]
    total and HDL cholesterol measured by commercial lab
  • A1c [ Time Frame: 6, 12, 24 months ]
    measured by commercial lab
  • Fruit and vegetable intake at 6 months [ Time Frame: 12, 18, and 24 months ]
    Measured by Block fruit and vegetable screener
  • Weight [ Time Frame: 6, 12, 18, 24 ]
    Measured by electronic scale
  • Health related quality of life [ Time Frame: 6, 12, 24 months ]
    SF-12 instrument
  • Genomic predictors of lifestyle change [ Time Frame: 6-, 12-, 18- and 24-month follow-up ]
    A systems approach to developing genomic models integrating clinical and genomic data.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart-Healthy Lenoir Lifestyle Study
Official Title  ICMJE Community-Based Lifestyle Intervention to Reduce CVD Risk & Disparities in Risk
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Obesity
Intervention  ICMJE
  • Behavioral: Maintenance of Weight Loss--Control
    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.
  • Behavioral: Maintenance of Weight Loss--Experimental
Study Arms  ICMJE
  • Active Comparator: Maintenance of Weight Loss--Control
    The control arm will receive bi-monthly telephone contacts during the one-year maintenance phase.
    Intervention: Behavioral: Maintenance of Weight Loss--Control
  • Experimental: Maintenance of Weight Loss--Experimental
    The experimental arm will receive monthly telephone contacts for one year during the maintenance phase.
    Intervention: Behavioral: Maintenance of Weight Loss--Experimental
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2014)
339
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2011)
400
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years or older
  2. live in Lenoir County or a neighboring county in Eastern North Carolina
  3. anyone enrolled in the Lifestyle study is eligible to participate in the genomics component of the project.

Exclusion Criteria:

  1. non-English speaking
  2. treatment of psychosis
  3. alcohol or substance abuse within the two last years
  4. 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
  5. estimated creatinine clearance less than 30 ml/min
  6. lack of access to phone
  7. advanced dementia
  8. 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:

  1. the investigators will not invite pregnant women to take part in the weight loss study.
  2. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01433484
Other Study ID Numbers  ICMJE 10-0395LS
P50HL105184 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Thomas C. Keyserling, MD, MPH UNC-Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP