Eating Behavior, Nutrition, Healthy
Conditions
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.
Interventions
BEHAVIORALPlant-based diet
Participants will receive a behavioral intervention on a plant-based diet in partnership with a local restaurant.
OTHERVoucher only
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.
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Outcome results
None listed