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Nutritious Eating With Soul (The NEW Soul Study)

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ClinicalTrials.gov Identifier: NCT03354377
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of South Carolina

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

  3. Examine long-term changes in CVD risk factors and body weight at 24 months.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Risk Factors Overweight and Obesity Behavioral: Dietary Intervention Meetings Behavioral: Physical Activity Behavioral: Podcasts/Mailings Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 6, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354377


Contacts
Contact: Mary J Wilson, MPH 803-777-1902 mjwilson@mailbox.sc.edu

Locations
United States, South Carolina
Discovery Recruiting
Columbia, South Carolina, United States, 29208
Contact: Brie Turner-McGrievy, PhD    803-777-3932    brie@sc.edu   
Contact: Mary J Wilson, MPH    803-777-1902    mjwilson@mailbox.sc.edu   
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Brie Turner-McGrievy, PhD, MS, RD University of South Carolina

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT03354377     History of Changes
Other Study ID Numbers: Pro00064855
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Cardiovascular Diseases
Overweight
Body Weight
Signs and Symptoms