Heart-Healthy Lenoir Lifestyle Study
|Cardiovascular Disease Obesity||Behavioral: Maintenance of Weight Loss--Control Behavioral: Maintenance of Weight Loss--Experimental||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Community-Based Lifestyle Intervention to Reduce CVD Risk & Disparities in Risk|
- 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
- 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.
|Study Start Date:||September 2011|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Maintenance of Weight Loss--Control
The control arm will receive bi-monthly telephone contacts during the one-year maintenance phase.
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.
Experimental: Maintenance of Weight Loss--Experimental
The experimental arm will receive monthly telephone contacts for one year during the maintenance phase.
|Behavioral: Maintenance of Weight Loss--Experimental|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433484
|United States, North Carolina|
|Heart Healthy Lenoir Project, Kinston Enterprise Center|
|Kinston, North Carolina, United States, 28501|
|Principal Investigator:||Thomas C. Keyserling, MD, MPH||UNC-Chapel Hill|