ObesityNEWSoul@RVNCT04513769
Nutritious Eating With Soul at Rare Variety Cafe
A study testing Vegan diet in people with Obesity, run by University of South Carolina at 1 site in United States.
Trial summary
To date, few dissemination and implementation (D\&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims: Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Vegan diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- between 18-65 years old
- be free on meeting night (Tuesday at 6PM)
- be free of eating disorder
- be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
- willing to travel weekly to Rare Variety Café
Who cannot join
- currently following a plant-based/vegan diet
- have a body mass index of under 25 or over 49.9 kg/m2
- currently on medication for diabetes
- women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
- currently participating in a weight loss program or taking weight loss medications
- recent weight loss (>10lbs in the last 6 months)
- living in the same household as somebody already participating in the larger NEW Soul Study at the University of South Carolina
- currently in the NEW Soul study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation
To date, few dissemination and implementation (D\&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims:
Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through a train-the-trainer approach in a soul food vegan restaurant.
Read more
Aim 2: Assess resource use and cost associated with a train-the-trainer D\&I approach in a restaurant setting.
Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight loss, and quality of life from baseline to follow-up (3-months) and at maintenance (9-months).
Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.
- Conditions
- Obesity
- Being tested
- Vegan diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan dietBehavioural
Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Experimental | This is a single-arm study so all participants receive the same intervention. Receives: Behavioral: Vegan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Assess changes in body weight
Measured: 0, 3, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start8 Sep 2020
- Primary completion31 Dec 2021
- Study completion30 Apr 2022
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 ObesityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Bernhart, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513769
- Sponsor's protocol ID
- Pro00100991
- Acronym
- NEWSoul@RV
- Status last verified
- May 2022
- First submitted
- 11 Aug 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernhart JA, Turner-McGrievy GM, Wilson MJ, Sentman C, Wilcox S, Rudisill C. NEW Soul in the neighborhood-reach and effectiveness of a dissemination and implementation feasibility study. Transl Behav Med. 2023 Apr 3;13(3):123-131. doi: 10.1093/tbm/ibac080.
PubMed 36689305
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation
- ClinicalTrials.gov ID
- NCT04513769
- Acronym / sponsor ID
- NEWSoul@RV / Pro00100991
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 14 Aug 2020 (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.
To date, few dissemination and implementation (D\&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims:
Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through a train-the-trainer approach in a soul food vegan restaurant.
Aim 2: Assess resource use and cost associated with a train-the-trainer D\&I approach in a restaurant setting.
Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight loss, and quality of life from baseline to follow-up (3-months) and at maintenance (9-months).
Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Experimental | Behavioral: Vegan dietThis is a single-arm study so all participants receive the same intervention. |
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
- between 18-65 years old
- be free on meeting night (Tuesday at 6PM)
- be free of eating disorder
- be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
Key exclusion criteria (8 listed)
- currently following a plant-based/vegan diet
- have a body mass index of under 25 or over 49.9 kg/m2
- currently on medication for diabetes
- women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
- currently participating in a weight loss program or taking weight loss medications
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 |
|---|---|---|
| Vegan dietParticipants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant | Behavioural | Study participants |
Primary outcome
body weight
Time frame: 0, 3, and 12 months
Assess changes in body weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 36689305Bernhart JA, Turner-McGrievy GM, Wilson MJ, Sentman C, Wilcox S, Rudisill C. NEW Soul in the neighborhood-reach and effectiveness of a dissemination and implementation feasibility study. Transl Behav Med. 2023 Apr 3;13(3):123-131. doi: 10.1093/tbm/ibac080.
- Individual participant dataSharing planned: No
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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 Vegan diet in people with Obesity, 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: finished, as of the sponsor's last update on 17 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
body weight (time frame: 0, 3, and 12 months). 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 NCT04513769, 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 17 May 2022.