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NCT05659966
Nutritious Eating With Soul Dissemination and Implementation
Conditions: Nutrition, Healthy, Eating Behavior
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 228
Sponsor: University of South Carolina
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Self-identify as African AmericanBe between the ages of 18-65 yearsBody Mass Index between 25- 49.9 kg/m2Able to travel to restaurant for classesBe able to attend all monitoring and weekly class visitsBe willing to be randomized to either groupExclusion Criteria:Currently following a plant-based dietDiagnosed with diabetes that is controlled by medicationCurrently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)Under the age of 18 years oldOver the age of 65 years oldCurrently participating in a weight loss programHas lost more than 10 pounds in the past 6 monthsPotential eating disorder
Source: ClinicalTrials.gov (NCT05659966). StuddyBuddy aggregates publicly available trial information.