Cardiovascular Disease Risk Factors, Overweight and Obesity
Conditions
Brief summary
This study addresses two challenges seen among African American (AA) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD) risk: poor weight loss results and high attrition rates. Investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for AA adults living in the South. Therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk factors and weight as compared with an omni diet. The study will randomize overweight AA adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. Investigators will accomplish objectives and test hypotheses by following two specific primary aims: Primary Aims: Using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in: 1. Risk factors for CVD, including LDL cholesterol and blood pressure; and 2. Body weight. Secondary Aim 3. Examine long-term changes in CVD risk factors and body weight at 24 months.
Interventions
BEHAVIORALDietary Intervention Meetings
Participants will attend classes once per week for the first 6 months, bi-weekly for the next 6 months; then once a month for the last 12 months.
BEHAVIORALPhysical Activity
Participants will be given the following exercise recommendations: strength training twice per week and ≥75 min of vigorous or ≥150 min of moderate PA per week and will be provided with accelerometers.
BEHAVIORALPodcasts/Mailings
Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as African American * Be between the ages of 18-65 years * Body Mass Index between 25- 49.9 kg/m2 * Live in the Columbia, SC/Midlands area * Be able to attend all monitoring and weekly class visits * Be willing to be randomized to either diet
Exclusion criteria
* Currently following a vegan diet * Diagnosed with diabetes that is controlled by medication * Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months) * Under the age of 18 years old * Over the age of 65 years old * Currently participating in a weight loss program * Has lost more than 10 pounds in the past 6 months * Diagnosed with stroke or heart attack
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Disease Prevention based on dietary approach. | Two years | Which dietary approach (vegan or omni) best targets both cardiovascular disease prevention and weight loss among overweight African Americans. |
Countries
United States
Outcome results
None listed