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Nutritious Eating With Soul Dissemination and Implementation
NCT05659966 · View on ClinicalTrials.gov ↗
Study Summary
The investigators will conduct a full dissemination and implementation study using a type 2 hybrid effectiveness-implementation design. The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness and implementation of community-delivered, 3-month NEW Soul program among participants (N=228). Using a randomized design, the investigators will assess effectiveness of two delivery approaches: (1) In-person, live weekly classes with restaurant vouchers (intervention) or (2) restaurant voucher-only (active control). The investigators will also conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher-only with the outcome of cost/change in weight, healthy eating index, and quality adjusted life year. Lastly, the investigators will examine the implementation of the NEW Soul study with participants and intervention staff.
Conditions Studied
Interventions
- BEHAVIORAL Plant-based diet
- OTHER Voucher only
Study Locations (1)
South Carolina
- Mimsy's Restaurant — Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2023-04-03 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05659966
The ClinicalTrials.gov registry entry for NCT05659966 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 228 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 88 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Nutrition, Healthy appearing as the primary indexed condition, and to 2 interventions — of which Plant-based diet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05659966 reports 1 study location spanning 1 distinct geographic area — top geographies include South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05659966 about?
NCT05659966 is a clinical study titled "Nutritious Eating With Soul Dissemination and Implementation". The investigators will conduct a full dissemination and implementation study using a type 2 hybrid effectiveness-implementation design. The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness and...
What is the current status of trial NCT05659966?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 228 participants. The study started on 2023-04-03. Estimated completion is 2027-03-31.
What conditions does trial NCT05659966 study?
This clinical trial studies the following conditions: Nutrition, Healthy, Eating Behavior. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05659966?
The interventions under investigation include: Plant-based diet (BEHAVIORAL), Voucher only (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05659966?
This trial is sponsored by University of South Carolina, which has 88 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05659966 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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