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Plant-Based Diet for Healthy Nutrition

N/A
Recruiting
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-months
Awards & highlights

Study Summary

This trial will assess the effectiveness & implementation of a program delivered through two vegan soul food restaurants, with outcomes of cost/change in weight, eating habits, & quality of life.

Who is the study for?
This trial is for African American individuals aged 18-65 with a BMI of 25-49.9 who are not currently on a plant-based diet or in another weight loss program. Participants must be able to attend classes at the restaurant and all monitoring visits, and cannot have diabetes controlled by medication or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests the effectiveness of a community-delivered, 3-month NEW Soul program promoting healthy nutrition through two methods: in-person weekly classes with restaurant vouchers versus receiving only the vouchers. The impact on weight, eating habits, and quality of life will also be analyzed for cost-effectiveness.See study design
What are the potential side effects?
Since this trial involves dietary changes to a plant-based diet, potential side effects may include digestive adjustments like bloating or gas initially as the body adapts to increased fiber intake. Nutritional deficiencies are possible if the diet isn't well-balanced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in body weight
Changes in diet quality
Secondary outcome measures
Cost-effectiveness
Implementation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: ControlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plant-based diet
2021
N/A
~360

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor
211 Previous Clinical Trials
120,231 Total Patients Enrolled
1 Trials studying Eating Disorders
13 Patients Enrolled for Eating Disorders

Media Library

Nutritious Eating With Soul Dissemination and Implementation Clinical Trial Eligibility Overview. Trial Name: NCT05659966 — N/A
Eating Disorders Research Study Groups: Control, Intervention
Eating Disorders Clinical Trial 2023: Nutritious Eating With Soul Dissemination and Implementation Highlights & Side Effects. Trial Name: NCT05659966 — N/A
Nutritious Eating With Soul Dissemination and Implementation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05659966 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies in this clinical trial?

"Affirmative. According to the clinicaltrials.gov listing, this medical trial is actively recruiting patients, with the initial posting dated April 1st 2023 and a recent update on December 13th 2022. The study team seeks 228 individuals across one site for participation in their research endeavour."

Answered by AI

Does this research endeavor involve participants aged 45 or over?

"Patients aged 18 to 65 are eligible for this clinical trial. Additionally, there are 10 studies available for minors and 17 offers that target senior citizens."

Answered by AI

What is the current enrollment of participants in this research project?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this medical research, first posted April 1st 2023 and lately revised December 13th 2022 is actively recruiting individuals to participate. This trial requires 228 participants across a single site."

Answered by AI

Could I potentially enroll in this medical trial?

"This trial is searching for 228 individuals with an age range of 18-65 years, a BMI between 25 and 49.9 kg/m2, the capability to attend restaurant classes as well as all monitoring sessions and weekly visits, be amenable to randomization into either group, and who self-identify as African American."

Answered by AI
~152 spots leftby Mar 2027