Nutrition, HealthyNCT05659966
Nutritious Eating With Soul Dissemination and Implementation
A study testing Plant-based diet and Voucher only in people with Nutrition, Healthy and Eating Behavior, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Eating Behavior
- What is being tested?
- Plant-based diet and Voucher only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as African American
- Be between the ages of 18-65 years
- Body Mass Index between 25- 49.9 kg/m2
- Able to travel to restaurant for classes
- Be able to attend all monitoring and weekly class visits
- Be willing to be randomized to either group
Who cannot join
- Currently following a plant-based 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
- Potential eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NEW Soul D&I: Expanding the Reach of the Nutritious Eating With Soul (NEW Soul) Program
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).
Read more
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
- Nutrition, Healthy, Eating Behavior
- Being tested
- Plant-based diet, Voucher only
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietBehavioural
Participants will receive a behavioral intervention on a plant-based diet in partnership with a local restaurant.
Voucher onlyOther
Participants will receive vouchers to a local restaurant. Participants will not attend nutrition classes but will receive a class at the end of the 12-week study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention condition participants will be instructed to follow a plant-based diet. The intervention participants will receive weekly group classes for 3 months at a local restaurant and will receive guidance on how to choose foods to meet their nutrient needs that fit within the vegan diet. The intervention participants will receive a voucher each week for a free plant-based meal at the restaurant. Receives: Behavioral: Plant-based diet |
| Control | Active comparator | Participants in the active control condition will receive meal vouchers to the restaurant. The active control condition participants will not receive any instruction to follow a particular diet or support. Participants in this condition will receive all intervention material and attend a class at the end of the study to learn about the intervention diet. Receives: Other: Voucher only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Changes in body weight in kilograms
Measured: 3-months
Changes in diet quality
Changes in dietary quality as assessed by the Healthy Eating Index
Measured: 3-months
Secondary outcomes (2)
Cost-effectiveness
The investigators will assess the costs between delivering the in-person intervention plus voucher vs. voucher-only with the outcome of cost per change in participant body weight, healthy eating index score, and quality adjusted life year (QALY). The cost-effectiveness evaluation will also include estimating costs of the intervention itself (e.g., training, delivery, infrastructure).
Measured: 3-months
Implementation
Implementation will be assessed using qualitative data collection with participants via focus groups and restaurant staff leading the intervention via in-depth interviews.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start3 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659966
- Sponsor's protocol ID
- Pro00116789
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, data will be shared with other researchers. Data will not be publicly available to protect participant confidentiality. The informed consent document will include information that de-identified data may potentially be shared with other researchers.
Publications
Bernhart JA, Turner-McGrievy GM, Bell A, Wilcox S, Rudisill AC, Duncan T, Peterson C, Etheredge J. Restaurant-based NEW Soul intervention with meal provision improves weight loss among African American adults versus meal provision alone. J Nutr. 2026 Sep 11:101826. doi: 10.1016/j.tjnut.2026.101826. Online ahead of print.
PubMed 42727855
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEW Soul D&I: Expanding the Reach of the Nutritious Eating With Soul (NEW Soul) Program
- ClinicalTrials.gov ID
- NCT05659966
- Acronym / sponsor ID
- Pro00116789
- Conditions
- Nutrition, Healthy, Eating Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Plant-based dietThe intervention condition participants will be instructed to follow a plant-based diet. The intervention participants will receive weekly group classes for 3 months at a local restaurant and will receive guidance on how to choose foods to meet their nutrient needs that fit within the vegan diet. The intervention participants will receive a voucher each week for a free plant-based meal at the restaurant. |
| Control | Active comparator | Other: Voucher onlyParticipants in the active control condition will receive meal vouchers to the restaurant. The active control condition participants will not receive any instruction to follow a particular diet or support. Participants in this condition will receive all intervention material and attend a class at the end of the study to learn about the intervention diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as African American
- Be between the ages of 18-65 years
- Body Mass Index between 25- 49.9 kg/m2
- Able to travel to restaurant for classes
- Be able to attend all monitoring and weekly class visits
Key exclusion criteria (8 listed)
- Currently following a plant-based 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based dietParticipants will receive a behavioral intervention on a plant-based diet in partnership with a local restaurant. | Behavioural | Intervention |
| Voucher onlyParticipants will receive vouchers to a local restaurant. Participants will not attend nutrition classes but will receive a class at the end of the 12-week study. | Other | Control |
Primary outcome
Changes in body weight
Time frame: 3-months
Changes in body weight in kilograms
Changes in diet quality
Time frame: 3-months
Changes in dietary quality as assessed by the Healthy Eating Index
2 secondary outcomes
Cost-effectiveness
Time frame: 3-months
Implementation
Time frame: 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Derived from this study: PubMed 42727855Bernhart JA, Turner-McGrievy GM, Bell A, Wilcox S, Rudisill AC, Duncan T, Peterson C, Etheredge J. Restaurant-based NEW Soul intervention with meal provision improves weight loss among African American adults versus meal provision alone. J Nutr. 2026 Sep 11:101826. doi: 10.1016/j.tjnut.2026.101826. Online ahead of print.
- Individual participant dataSharing planned: Yes. Upon reasonable request, data will be shared with other researchers. Data will not be publicly available to protect participant confidentiality. The informed consent document will include information that de-identified data may potentially be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based diet and Voucher only in people with Nutrition, Healthy and Eating Behavior, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.