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Nutritious Eating With Soul (The NEW Soul Study)

NCT03354377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-06-02

No results posted yet for this study

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.

Conditions

  • Cardiovascular Disease Risk Factors
  • Overweight and Obesity

Interventions

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.

BEHAVIORAL

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.

BEHAVIORAL

Podcasts/Mailings

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

Sponsors & Collaborators

  • University of South Carolina

    lead OTHER

Principal Investigators

  • Brie Turner-McGrievy, PhD, MS, RD · University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2021-05-21
Completion
2021-05-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354377 on ClinicalTrials.gov