Nutritious Eating With Soul (The NEW Soul Study)

Overweight and Obesity Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cardiovascular Disease Risk Factors
• Cardiovascular Diseases
• Overweight
• Overweight and Obesity

• NCT number: NCT03354377
• Study type: Interventional
• Source: University of South Carolina
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Completion date: May 21, 2021