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Nutritious Eating With Soul at Rare Variety Cafe (NEWSoul@RV)

University of South Carolina logo

University of South Carolina

Status

Completed

Conditions

Obesity

Treatments

Behavioral: Vegan diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04513769
Pro00100991

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Study participants
Experimental group
Description:
This is a single-arm study so all participants receive the same intervention.
Treatment:
Behavioral: Vegan diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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