Nutritious Eating With Soul (The NEW Soul Study)

Study Overview
=================
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: Risk factors for CVD, including LDL cholesterol and blood pressure; and Body weight. Secondary Aim Examine long-term changes in CVD risk factors and body weight at 24 months.

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

Conditions
-----------------
Cardiovascular Disease Risk Factors, Overweight and Obesity

Intervention / Treatment
-----------------
* Behavioral: Dietary Intervention Meetings
* Behavioral: Physical Activity
* Behavioral: Podcasts/Mailings


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegan Diet<br>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<br>* 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.<br>Behavioral: Physical Activity<br>* 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.<br>Behavioral: Podcasts/Mailings<br>* Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.<br>|
| Experimental: Omnivorous (Omni) Diet<br>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<br>* 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.<br>Behavioral: Physical Activity<br>* 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.<br>Behavioral: Podcasts/Mailings<br>* Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |