Nutritious Eating With Soul (The NEW Soul Study)
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
1 other identifier
interventional
159
1 country
1
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.
- 3.Examine long-term changes in CVD risk factors and body weight at 24 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2017
CompletedFirst Posted
Study publicly available on registry
November 27, 2017
CompletedStudy Start
First participant enrolled
May 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2021
CompletedJune 2, 2023
June 1, 2023
3 years
November 21, 2017
June 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Two years
Study Arms (2)
Vegan Diet
EXPERIMENTALParticipants 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.
Omnivorous (Omni) Diet
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Discovery
Columbia, South Carolina, 29208, United States
Related Publications (7)
Turner-McGrievy GM, Wilcox S, Frongillo EA, Murphy EA, Kim Y, Hu EA, Okpara N, Bailey S. Impact of diet adherence on weight and lipids among African American participants randomized to vegan or omnivorous diets. Obes Sci Pract. 2024 Sep 27;10(5):e70009. doi: 10.1002/osp4.70009. eCollection 2024 Oct.
PMID: 39345782DERIVEDTurner-McGrievy GM, Wilcox S, Frongillo EA, Kim Y, Okpara N, Wilson M. Differences in dietary acceptability, restraint, disinhibition, and hunger among African American participants randomized to either a vegan or omnivorous soul food diet. Appetite. 2024 May 1;196:107280. doi: 10.1016/j.appet.2024.107280. Epub 2024 Feb 17.
PMID: 38373534DERIVEDBernhart JA, Quattlebaum M, Eustis S, Okpara N, Wilson MJ, Sentman C, Turner-McGrievy GM. "It's Gonna Be Okay"-A Qualitative Exploration of the COVID-19 Pandemic's Effects on African American Participants During a Dietary Intervention Study. J Acad Nutr Diet. 2023 Dec;123(12):1763-1771. doi: 10.1016/j.jand.2023.07.003. Epub 2023 Jul 16.
PMID: 37437808DERIVEDTurner-McGrievy GM, Wilcox S, Frongillo EA, Murphy EA, Hutto B, Wilson M, Davey M, Bernhart JA, Okpara N, Bailey S, Hu E. Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African American Adults: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250626. doi: 10.1001/jamanetworkopen.2022.50626.
PMID: 36633848DERIVEDBernhart JA, Fellers AW, Wilson MJ, Hutto B, Bailey S, Turner-McGrievy GM. COVID-19 Pandemic Associations on Mental and Physical Health in African Americans Participating in a Behavioral Intervention. J Racial Ethn Health Disparities. 2023 Dec;10(6):3070-3076. doi: 10.1007/s40615-022-01481-6. Epub 2022 Dec 5.
PMID: 36469289DERIVEDHooper 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.
PMID: 32827219DERIVEDHooper 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.
PMID: 32428300DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brie Turner-McGrievy, PhD, MS, RD
University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 21, 2017
First Posted
November 27, 2017
Study Start
May 7, 2018
Primary Completion
May 21, 2021
Study Completion
May 21, 2021
Last Updated
June 2, 2023
Record last verified: 2023-06