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OpenTrials
Completed

NCT Number: NCT04513769

Nutritious Eating With Soul at Rare Variety Cafe

To date, few dissemination and implementation (D&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims:

Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through a train-the-trainer approach in a soul food vegan restaurant.

Aim 2: Assess resource use and cost associated with a train-the-trainer D&I approach in a restaurant setting.

Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight loss, and quality of life from baseline to follow-up (3-months) and at maintenance (9-months).

Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, 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
  • between 18-65 years old
  • be free on meeting night (Tuesday at 6PM)
  • be free of eating disorder
  • be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
  • willing to travel weekly to Rare Variety Café

Exclusion criteria

  • currently following a plant-based/vegan diet
  • have a body mass index of under 25 or over 49.9 kg/m2
  • currently on medication for diabetes
  • women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
  • currently participating in a weight loss program or taking weight loss medications
  • recent weight loss (>10lbs in the last 6 months)
  • living in the same household as somebody already participating in the larger NEW Soul Study at the University of South Carolina
  • currently in the NEW Soul study

Treatment and study plan

Vegan diet

Behavioral

Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant

Primary outcomes

  1. body weight

    Time frame: 0, 3, and 12 months

    Assess changes in body weight

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation

Acronym: NEWSoul@RV

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 14, 2020
Registry last updated
May 17, 2022

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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