Nutritious Eating With Soul (The NEW Soul Study)

University of South Carolina

Status: Completed

Conditions: Overweight and Obesity; Cardiovascular Disease Risk Factors

Treatments: Behavioral: Podcasts/Mailings; Behavioral: Physical Activity; Behavioral: Dietary Intervention Meetings

Study type: Interventional

Funder types: Other

Identifiers

NCT03354377

Pro00064855

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 2 patient groups

Vegan Diet

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary Intervention Meetings

Behavioral: Podcasts/Mailings

Behavioral: Physical Activity

Omnivorous (Omni) Diet

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary Intervention Meetings

Behavioral: Podcasts/Mailings

Behavioral: Physical Activity