Nutritious Eating With Soul (The NEW Soul Study)
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/25/2018 |
| Start Date: | May 7, 2018 |
| End Date: | June 30, 2022 |
| Contact: | Mary J Wilson, MPH |
| Email: | mjwilson@mailbox.sc.edu |
| Phone: | 803-777-1902 |
A Nutrition-Based Approach to Reduce Heart Disease Risk Among Overweight African Americans: Use of Soul Food Plant-Based or Omnivorous Diets to Address Cardiovascular Disease
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.
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.
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
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