Clinical trial NCT01433484: Heart-Healthy Lenoir Lifestyle Study
Official title: Community-Based Lifestyle Intervention to Reduce CVD Risk & Disparities in Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Obesity
Keywords: cardiovascular disease
coronary heart disease
obesity
weight loss
genomics
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-09-14
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohort study: fruit and vegetable intake at 6 months
timeFrame: 6 months
measure: Embedded randomized trial: maintenance of weight loss
timeFrame: 1 year after maintenance of weight loss trial begins
Secondary outcomes:
measure: Physical activity
timeFrame: 6m, 12m, 18m, 24 m
measure: Blood pressure
timeFrame: 6, 12, 18, 24 months
measure: Blood lipids
timeFrame: 12, 24 months
measure: A1c
timeFrame: 6, 12, 24 months
measure: Fruit and vegetable intake at 6 months
timeFrame: 12, 18, and 24 months
measure: Weight
timeFrame: 6, 12, 18, 24
measure: Health related quality of life
timeFrame: 6, 12, 24 months
measure: Genomic predictors of lifestyle change
timeFrame: 6-, 12-, 18- and 24-month follow-up
Other outcomes:
Locations:
city: Kinston
country: United States
facility: Heart Healthy Lenoir Project, Kinston Enterprise Center
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Thomas C. Keyserling, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.