Nutritious Eating with Soul Dissemination and Implementation

Not Applicable

Recruiting

• Conditions: Nutrition, Healthy; Eating Behavior

• 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

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Study Start: 2023-04-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-29
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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