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Completed

NCT Number: NCT03354377

Nutritious Eating With Soul (The NEW Soul Study)

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.

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Key information

Conditions

Cardiovascular Disease Risk Factors Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Discovery

Columbia, South Carolina, 29208, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention Meetings

Behavioral

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 activity

Behavioral

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/Mailings

Behavioral

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2017
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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