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NCT Number: NCT05659966

Nutritious Eating With Soul Dissemination and Implementation

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Nutrition, Healthy Behavior Behavior, Animal Eating Behavior Feeding Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mimsy's Restaurant

Columbia, South Carolina, 29228, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant-based diet

Behavioral

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

Voucher only

Other

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.

Primary outcomes

  1. Changes in body weight

    Time frame: 3-months

    Changes in body weight in kilograms

  2. Changes in diet quality

    Time frame: 3-months

    Changes in dietary quality as assessed by the Healthy Eating Index

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2022
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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