AzTrials
AzTrials

Cardiovascular Disease Risk FactorsNCT03354377

Nutritious Eating With Soul (The NEW Soul Study)

A study testing Dietary Intervention Meetings, Physical Activity and Podcasts/Mailings in people with Cardiovascular Disease Risk Factors and Overweight and Obesity, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Dietary Intervention Meetings, Physical Activity and Podcasts/Mailings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
1 siteUnited States
Study dates
7 May 2018to 21 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Discovery

    Columbia, South Carolina, 29208

Other trials in United States

About this 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

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.
Being tested
Dietary Intervention Meetings, Physical Activity, Podcasts/Mailings
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary Intervention MeetingsBehavioural

    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.

  • Physical ActivityBehavioural

    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.

  • Podcasts/MailingsBehavioural

    Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.

Study groups in NCT03354377
Study groupRoleWhat they receive
Vegan DietExperimentalParticipants 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.
Receives: Behavioral: Dietary Intervention Meetings; Behavioral: Physical Activity; Behavioral: Podcasts/Mailings
Omnivorous (Omni) DietExperimentalParticipants 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.
Receives: Behavioral: Dietary Intervention Meetings; Behavioral: Physical Activity; Behavioral: Podcasts/Mailings

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start7 May 2018
  3. Primary completion21 May 2021
  4. Study completion21 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03354377
Sponsor's protocol ID
Pro00064855
Status last verified
Jun 2023
First submitted
21 Nov 2017
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bell A, Bernhart JA, Kim Y, Keseko EA, Turner-McGrievy G. The Association Between Power of Food Scale Scores and Weight Among Black/African American Individuals Consuming a Vegan or Low-Fat Omnivorous Diet in a Randomized Controlled Trial. J Nutr Metab. 2026 Apr 9;2026:4084525. doi: 10.1155/jnme/4084525. eCollection 2026.

    PubMed 41970465

  • 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.

    PubMed 39345782

  • Turner-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.

    PubMed 38373534

  • Bernhart 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.

    PubMed 37437808

  • Turner-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.

    PubMed 36633848

  • Bernhart 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.

    PubMed 36469289

  • 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.

    PubMed 32827219

  • 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.

    PubMed 32428300

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Intervention Meetings, Physical Activity and Podcasts/Mailings in people with Cardiovascular Disease Risk Factors and Overweight and Obesity, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular Disease Prevention based on dietary approach. (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03354377, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in