Nutritious Eating With Soul Dissemination and Implementation

Eating Behavior Clinical Trial

Official title:

NEW Soul D&I: Expanding the Reach of the Nutritious Eating With Soul (NEW Soul) Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659966
• Other study ID #: Pro00116789
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2023
• Source: University of South Carolina
• Contact: Gabrielle M Turner-McGrievy, PhD
• Phone: 803-777-3932
• Email: mcgrievy[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior

Intervention

Behavioral:
• Plant-based diet
Participants will receive a behavioral intervention on a plant-based diet in partnership with a local restaurant.

Other:
• Voucher 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.

Locations

Country	Name	City	State
United States	Mimsy's Restaurant	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	Changes in body weight	Changes in body weight in kilograms	3-months
Primary	Changes in diet quality	Changes in dietary quality as assessed by the Healthy Eating Index	3-months
Secondary	Cost-effectiveness	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).	3-months
Secondary	Implementation	Implementation will be assessed using qualitative data collection with participants via focus groups and restaurant staff leading the intervention via in-depth interviews.	3-months