Nutritious Eating With Soul (The NEW Soul Study)

University of South Carolina159 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

159

Conditions

Cardiovascular Disease Risk Factors Overweight and Obesity

Interventions

Dietary Intervention MeetingsBEHAVIORAL

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 ActivityBEHAVIORAL

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/MailingsBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Nutritious Eating With Soul (The NEW Soul Study)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes