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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04513769
Other study ID # Pro00100991
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2020
Est. completion date April 30, 2022

Study information

Verified date May 2022
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Vegan diet
Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant

Locations

Country Name City State
United States University of South Carolina Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary body weight Assess changes in body weight 0, 3, and 12 months
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