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Clinical Trials/NCT03354377
NCT03354377
Completed
Not Applicable

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

University of South Carolina1 site in 1 country159 target enrollmentMay 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Disease Risk Factors
Sponsor
University of South Carolina
Enrollment
159
Locations
1
Primary Endpoint
Cardiovascular Disease Prevention based on dietary approach.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2018
End Date
May 21, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brie Turner-McGrievy

Associate Professor

University of South Carolina

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cardiovascular Disease Prevention based on dietary approach.

Time Frame: Two years

Which dietary approach (vegan or omni) best targets both cardiovascular disease prevention and weight loss among overweight African Americans.

Study Sites (1)

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