Nutritious Eating With Soul (The NEW Soul Study)

Sponsor
University of South Carolina (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03354377
Collaborator
(none)
130
1
2
49.8
2.6

Study Details

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:

  1. Risk factors for CVD, including LDL cholesterol and blood pressure; and

  2. Body weight.

Secondary Aim

  1. Examine long-term changes in CVD risk factors and body weight at 24 months.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dietary Intervention Meetings
  • Behavioral: Physical Activity
  • Behavioral: Podcasts/Mailings
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
May 7, 2018
Actual Primary Completion Date :
May 6, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Discovery Columbia South Carolina United States 29208

Sponsors and Collaborators

  • University of South Carolina

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brie Turner-McGrievy, Associate Professor, University of South Carolina
ClinicalTrials.gov Identifier:
NCT03354377
Other Study ID Numbers:
  • Pro00064855
First Posted:
Nov 27, 2017
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021