Nutritious Eating With Soul Dissemination and Implementation

Sponsor
University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT05659966
Collaborator
(none)
228
1
2
48
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Plant-based diet
  • Other: Voucher only
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
NEW Soul D&I: Expanding the Reach of the Nutritious Eating With Soul (NEW Soul) Program
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Mar 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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.

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

Active Comparator: Control

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in body weight [3-months]

    Changes in body weight in kilograms

  2. Changes in diet quality [3-months]

    Changes in dietary quality as assessed by the Healthy Eating Index

Secondary Outcome Measures

  1. 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).

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mimsy's Restaurant Columbia South Carolina United States 29228

Sponsors and Collaborators

  • University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brie Turner-McGrievy, Associate Professor, University of South Carolina
ClinicalTrials.gov Identifier:
NCT05659966
Other Study ID Numbers:
  • Pro00116789
First Posted:
Dec 21, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 21, 2022