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Shared Decision-Making Intervention for Gestational Diabetes

N/A

Recruiting

Led By Kenrik Duru, MD,MSHS

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of prediabetes in prior 36 months defined by either 1) most recent HbA1c 5.7-6.4% or 2) most recent FPG 100-125 mg/dL or 3) prior diabetes diagnostic codes + abnormal labs

Be between 18 and 65 years old

Must not have

Last available glomerular filtration rate (eGFR) <45 ml/min

Use of an anti-glycemic medication in prior 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether shared decision making can help women with a history of gestational diabetes lose weight and adopt diabetes prevention strategies.

Who is the study for?

This trial is for women who had gestational diabetes and are at risk of type 2 diabetes. They should have a BMI of 25 or higher (23 if Asian American), recent signs of prediabetes, and be part of the UCLA or Intermountain Healthcare Systems. Women can't join if they've had bariatric surgery recently, use anti-glycemic meds, are currently pregnant, or have severe kidney issues.

What is being tested?

The study tests whether shared decision-making helps these women lose weight and adopt strategies to lower their risk of developing type 2 diabetes. It involves working together with healthcare providers to make informed choices about preventing diabetes.

What are the potential side effects?

Since this intervention focuses on shared decision-making rather than medication or invasive procedures, it's not expected to cause typical side effects. However, lifestyle changes involved might lead to temporary discomfort like muscle soreness from new physical activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had prediabetes in the last 3 years, confirmed by tests or diagnosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, with an eGFR below 45 ml/min.

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I have taken medication for blood sugar control in the last year.

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My BMI is over 60 kg/m2.

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I have a history of diabetes.

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My primary language is not English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, and 24 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

Weight change

Secondary study objectives

Health-related quality of life

Uptake of DPP lifestyle program or metformin

Weight Change

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: Shared decision-making with pharmacistsExperimental Treatment1 Intervention

Participants randomized to the intervention arm will have an in-person visit to complete the baseline survey, record the participant's weight and receive a pharmacist-coordinated shared decision making intervention. Intervention participants will have follow-up research assessments visits at 6, 12 and 24 months.

Group II: Usual CareActive Control1 Intervention

Participants randomized to the usual care control arm will have an in-person visit with the research study team to complete the baseline survey and record the participant's weight. These participants will then return to usual care with research assessments at 6, 12 and 24 months follow-up.

0 / 6Eligibility criteria met