Status:

COMPLETED

Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes

Lead Sponsor:

Sansum Diabetes Research Institute

Conditions:

Diabetes Mellitus, Type 2

Diabetes Mel Gestational - in Pregnancy

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

Socioeconomically disadvantaged (SED) pregnant Latina women are disproportionately burdened by type 2 diabetes (T2D). Although lifestyle interventions can help to improve diabetes control, there are b...

Eligibility Criteria

Inclusion

  • Diabetes in pregnancy
  • ≥ 18 years old
  • Self-reported Hispanic and/or Latino/a heritage
  • BMI ≥ 26.0 kg/m2 and ≤ 42.0 kg/m2

Exclusion

  • Type 1 Diabetes
  • Active substance abuse with alcohol or drugs by self-report
  • Treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect outcome measures
  • Non-singleton fetus
  • Evidence of fetal malformation
  • HbA1c ≥ 10%
  • Unable to provide informed consent or unwilling to complete the study

Key Trial Info

Start Date :

April 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 27 2025

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT06218147

Start Date

April 1 2024

End Date

March 27 2025

Last Update

April 3 2025

Active Locations (1)

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Sansum Diabetes Research Institute

Santa Barbara, California, United States, 93105