Nutritious Eating with Soul Dissemination and Implementation
- Conditions
- Nutrition, HealthyEating Behavior
- Interventions
- Behavioral: Plant-based dietOther: Voucher only
- Registration Number
- NCT05659966
- Lead Sponsor
- University of South Carolina
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 228
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Plant-based diet 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. Control Voucher only 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.
- Primary Outcome Measures
Name Time Method Changes in body weight 3-months Changes in body weight in kilograms
Changes in diet quality 3-months Changes in dietary quality as assessed by the Healthy Eating Index
- Secondary Outcome Measures
Name Time Method Implementation 3-months Implementation will be assessed using qualitative data collection with participants via focus groups and restaurant staff leading the intervention via in-depth interviews.
Cost-effectiveness 3-months 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).
Trial Locations
- Locations (1)
Mimsy's Restaurant
🇺🇸Columbia, South Carolina, United States