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Behavioral Intervention

Dietary Intervention for Type 2 Diabetes (DG3D Trial)

N/A
Waitlist Available
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
18-65 years of age
Be able to attend all monitoring visits
Must not have
No recent or planned bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

This trialtests a tailored diet intervention for African American adults with obesity & type 2 diabetes risk factors. It looks at 3 healthy eating patterns for 12 weeks to see if it reduces risk.

Who is the study for?
This trial is for African American adults living in Columbia, SC with overweight/obesity and at least three risk factors for type 2 diabetes. Participants should be aged 18-65, have a BMI of 25-49.9, and not suffer from major diseases or conditions like thyroid issues or diabetes. They must commit to attending all sessions and accept random diet assignments.Check my eligibility
What is being tested?
The study tests the adoption of three diets based on U.S. Dietary Guidelines over a period of 12 weeks: U.S.-Style, Mediterranean, or Vegetarian. The aim is to tailor these diets culturally for African Americans at risk of type 2 diabetes.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects are minimal but may include temporary digestive adjustments as participants adapt to new eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I can attend all required check-ups.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had, nor am I planning to have, weight-loss surgery.

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
Body weight
Dietary quality
Hemoglobin A1c
Secondary outcome measures
Blood pressure

Trial Design

3Treatment groups
Experimental Treatment
Group I: Vegetarian dietExperimental Treatment1 Intervention
Participants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains no meat, poultry, or seafood. Compared with the Healthy U.S.-Style Eating Pattern, it contains more soy products, eggs, beans and peas, nuts and seeds, and whole grains.
Group II: US Healthy DietExperimental Treatment1 Intervention
Participants in this group will be assigned to follow the Healthy US dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern is based on the types and amounts of foods Americans typically consume. The main types of food in this eating pattern include a variety of vegetables; fruits; whole grains; fat-free or low-fat dairy; seafood, poultry, meat, and eggs; and nuts, seeds, and soy products.
Group III: Mediterranean dietExperimental Treatment1 Intervention
Participants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern. There is also less calcium and vitamin D because it includes fewer dairy foods.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention Meetings
2018
N/A
~160

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor
214 Previous Clinical Trials
121,293 Total Patients Enrolled

Media Library

Dietary Intervention Meetings (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04981847 — N/A
Type 2 Diabetes Research Study Groups: US Healthy Diet, Mediterranean diet, Vegetarian diet
Type 2 Diabetes Clinical Trial 2023: Dietary Intervention Meetings Highlights & Side Effects. Trial Name: NCT04981847 — N/A
Dietary Intervention Meetings (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04981847 — N/A
~15 spots leftby Jun 2025
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