Nutritious Eating With Soul (The NEW Soul Study)

June 1, 2023 updated by: Brie Turner-McGrievy, University of South Carolina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • Discovery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vegan Diet

Participants in this group will follow a plant-based vegan diet. The vegan group diet will be based on investigators' pilot work, which instructs participants to favor a diet built around whole grains, fruits, vegetables, and legumes. This group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide. A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course.

Interventions include intervention meetings, physical activity, and podcasts/mailings.
Behavioral: Dietary Intervention Meetings
Participants will attend classes once per week for the first 6 months, bi-weekly for the next 6 months; then once a month for the last 12 months.
Behavioral: Physical Activity
Participants will be given the following exercise recommendations: strength training twice per week and ≥75 min of vigorous or ≥150 min of moderate PA per week and will be provided with accelerometers.
Behavioral: Podcasts/Mailings
Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.
Experimental: Omnivorous (Omni) Diet

Participants in this group will follow a low-fat omni diet. The diet intervention for the omni group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide, A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course).

Interventions include intervention meetings, physical activity, and podcasts/mailings.
Behavioral: Dietary Intervention Meetings
Participants will attend classes once per week for the first 6 months, bi-weekly for the next 6 months; then once a month for the last 12 months.
Behavioral: Physical Activity
Participants will be given the following exercise recommendations: strength training twice per week and ≥75 min of vigorous or ≥150 min of moderate PA per week and will be provided with accelerometers.
Behavioral: Podcasts/Mailings
Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Investigators

  • Principal Investigator: Brie Turner-McGrievy, PhD, MS, RD, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2018

Primary Completion (Actual)

May 21, 2021

Study Completion (Actual)

May 21, 2021

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00064855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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