search
Back to results

Nutritious Eating With Soul (The NEW Soul Study)

Primary Purpose

Cardiovascular Disease Risk Factors, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention Meetings
Physical Activity
Podcasts/Mailings
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease Risk Factors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Discovery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vegan Diet

Omnivorous (Omni) Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 21, 2017
Last Updated
June 1, 2023
Sponsor
University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT03354377
Brief Title
Nutritious Eating With Soul (The NEW Soul Study)
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
May 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Risk factors for CVD, including LDL cholesterol and blood pressure; and Body weight. Secondary Aim Examine long-term changes in CVD risk factors and body weight at 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease Risk Factors, Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegan Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Omnivorous (Omni) Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Intervention Meetings
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Podcasts/Mailings
Intervention Description
Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.
Primary Outcome Measure Information:
Title
Cardiovascular Disease Prevention based on dietary approach.
Description
Which dietary approach (vegan or omni) best targets both cardiovascular disease prevention and weight loss among overweight African Americans.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brie Turner-McGrievy, PhD, MS, RD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Discovery
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32827219
Citation
Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.
Results Reference
derived
PubMed Identifier
32428300
Citation
Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.
Results Reference
derived

Learn more about this trial

Nutritious Eating With Soul (The NEW Soul Study)

We'll reach out to this number within 24 hrs