Nutritious Eating With Soul (The NEW Soul Study)

Completed · Not applicable

Conditions studied: Cardiovascular Disease Risk Factors, Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT03354377

Run by

University of South Carolina

People needed

159

Starts

2018-05-07

Expected to finish

2021-05-21

Last updated by the study team

2023-06-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Discovery — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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