Nutritious Eating With Soul (The NEW Soul Study)

Not Applicable

Completed

• Conditions: Cardiovascular Disease Risk Factors; Overweight and Obesity

• Registration Number: NCT03354377
• Lead Sponsor: University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Study Start: 2018-05-07
• Primary Completion: 2021-05-21
• Study Completion: 2021-05-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Discovery; 🇺🇸 Columbia, South Carolina, United States