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Behavioral Intervention

Diabetes Prevention Intervention for Prediabetes

N/A

Waitlist Available

Led By Sharon A. Brown, PhD

Research Sponsored by University of Texas at Austin

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 baseline and 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a lifestyle intervention designed to prevent type 2 diabetes in Mexican Americans with prediabetes. The intervention emphasizes preparing and eating healthy Mexican-American foods and increasing physical activity.

Eligible Conditions

Prediabetes
Obesity
Incretin Hormones in Polycystic Ovary Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in body mass index (BMI) at 12 months

Change from baseline in body mass index (BMI) at 24 months

Change from baseline in body mass index (BMI) at 3 months

+7 more

Secondary study objectives

Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 12 months

Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 24 months

Glucose tolerance test

+47 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Diabetes Prevention InterventionExperimental Treatment1 Intervention

The intervention is 12 weeks of education on diet and physical activity, followed by 15 biweekly support groups for problem solving. Then, 3 booster sessions are scheduled, each one at 6-month intervals. Further, motivational interviewing is infused into all group sessions.

Group II: Enhanced Usual CareActive Control1 Intervention

The comparator is an "enhanced" usual care control group that receives health care from personal physicians plus has access to: a) data collection sessions; b) individualized exit interviews with program staff after each data collection session to receive immediate feedback on lab results and trends in personal health indicators (e.g., BMI, A1C) and to ask questions; c) referral to a local physician or clinic, if needed; and d) Spanish-language materials on diabetes prevention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diabetes Prevention Intervention

2019

N/A

~550

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