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Diabetes Prevention for Mexican Americans

NCT03208010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-17

No results posted yet for this study

Summary

This study tests a culturally tailored lifestyle intervention designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Half the participants take part in a lifestyle program that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity; the other half take part in an "enhanced" usual care control group.

Conditions

  • Prediabetic State
  • Overweight and Obesity

Interventions

BEHAVIORAL

Diabetes Prevention Intervention

* Educational sessions with emphasis on physical activity, healthy cultural diets, and strategies to promote positive behavioral changes. * Specific goals set for weight loss and physical activities * Fitbits provided for monitoring physical activity goals * Weekly review of and feedback on effects of physical activity (Fitbits) and dietary changes (checklists) * 15 biweekly support group sessions plus 3 booster sessions every 6 months thereafter Note: In response to the COVID-19 pandemic, a remote version of the intervention was designed to provide the program remotely instead of via the usual in-person group format. This alternative strategy is designed to replace the biweekly support groups, which in the past focused on similar content, i.e., reviewing key educational content, demonstrations of healthy Mexican American recipes.

OTHER

Enhanced Usual Care

* Monitoring by existing personal physicians * Feedback on lab results * Referrals to physicians or clinics, if needed * Diabetes prevention educational materials

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Sharon A. Brown, PhD · University of Texas at Austin

  • Craig L. Hanis, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03208010 on ClinicalTrials.gov