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NCT03354377 · ClinicalTrials.gov registry record · NA
Nutritious Eating With Soul (The NEW Soul Study)
A NA study, sponsored by University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 159
- Enrollment target
NCT03354377 is a NA study that has completed, run by University of South Carolina. The registered enrollment target is 159 participants.
The verdict
NCT03354377, a NA study, has completed, sponsored by University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 159 participants
- Enrollment target
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.
Interventions
- BEHAVIORAL Physical Activity
- BEHAVIORAL Dietary Intervention Meetings
- BEHAVIORAL Podcasts/Mailings
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2021-05-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03354377
The ClinicalTrials.gov registry entry for NCT03354377 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Carolina, which has 157 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Physical Activity is the first listed.
NCT03354377 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03354377 about?
NCT03354377 is a clinical study titled "Nutritious Eating With Soul (The NEW Soul Study)". 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 ...
What is the current status of trial NCT03354377?
This trial is currently completed. It is a NA study. The enrollment target is 159 participants. The study started on 2018-05-07. Estimated completion is 2021-05-21.
What interventions are being tested in trial NCT03354377?
The interventions under investigation include: Physical Activity (BEHAVIORAL), Dietary Intervention Meetings (BEHAVIORAL), Podcasts/Mailings (BEHAVIORAL).
Who is sponsoring clinical trial NCT03354377?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
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