Nutritious Eating With Soul (The NEW Soul Study)

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354377
• Other study ID #: Pro00064855
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: May 21, 2021

Study information

• Verified date: June 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 21, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease Risk Factors
• Cardiovascular Diseases
• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Discovery	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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