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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

Study 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

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
350 Previous Clinical Trials
80,684 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
903 Previous Clinical Trials
320,677 Total Patients Enrolled
Sharon A. Brown, PhDPrincipal InvestigatorUniversity of Texas at Austin
1 Previous Clinical Trials
320 Total Patients Enrolled

Frequently Asked Questions

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

Who meets the criteria to be an eligible participant in this clinical experiment?

"Pre-diabetic individuals between the age of 25 and 65, who have not been diagnosed with diabetes (bar gestational) , impaired fasting glucose levels ranging from 100 to 125 mg/dL or impaired glucose tolerance scores between 140 and 199 mg/dL on a 2-hour post-load glucose test OR A1C values in 5.7%-6.4% range are welcomed to join this trial. Additionally, applicants must be Mexican American and cannot have previously partaken in any self-management education studies associated with diabetes."

Answered by AI

Is this trial still recruiting participants?

"Evidently, this trial is not actively recruiting patients. A glance at clinicaltrials.gov reveals that it was initially posted on April 1st 2017 and last updated a few days ago in the month of December 2021. Additionally, 487 other studies are still welcoming participants as we speak."

Answered by AI

What are the expected outcomes of this experimental endeavor?

"The primary objective of this medical trial, evaluated over a 12 month period, is to quantify change from baseline in body mass index (BMI). Secondary outcomes include changes from baseline to 24 months regarding the number and amount of foods consumed using the Food Frequency Questionnaire for Starr County Health Studies, shifts from baseline to 24 months concerning high-fat food consumption with the Saturated Fat/Cholesterol Avoidance Scale, as well as alterations from baseline at 12 months assessing perceived barriers towards healthier eating habits via the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies."

Answered by AI

Is the minimum age requirement for this medical experiment lower than 25 years old?

"Eligibility for this study is limited to those between the ages of 25 and 65; however, there are other trials available for younger (under 18) or older (over 65) patients with 60 and 333 studies respectively."

Answered by AI
~37 spots leftby Apr 2025