ACTIVE_NOT_RECRUITING

Nutritious Eating With Soul Dissemination and Implementation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-03
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05659966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-identify as African American
  2. * Be between the ages of 18-65 years
  3. * Body Mass Index between 25- 49.9 kg/m2
  4. * Able to travel to restaurant for classes
  5. * Be able to attend all monitoring and weekly class visits
  6. * Be willing to be randomized to either group
  1. * Currently following a plant-based diet
  2. * Diagnosed with diabetes that is controlled by medication
  3. * Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
  4. * Under the age of 18 years old
  5. * Over the age of 65 years old
  6. * Currently participating in a weight loss program
  7. * Has lost more than 10 pounds in the past 6 months
  8. * Potential eating disorder

Contacts and Locations

Study Locations (Sites)

Mimsy's Restaurant
Columbia, South Carolina, 29228
United States

Collaborators and Investigators

Sponsor: University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-03
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-04-03
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Nutrition, Healthy
  • Eating Behavior