Summary

Eligibility
for females ages 18-54 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Kenrik Duru (ucla)Tannaz Moin, MD,MBA,MSHS (ucla)

Description

Summary

Our goal is to test whether shared decision making for diabetes prevention can help women with a history of gestational diabetes mellitus (GDM) who are at high risk of developing type 2 diabetes (T2DM) increase weight loss and adoption of evidence based strategies to lower their risk of incident diabetes.

Details

Women with a history of gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes (T2DM) but evidence from the Diabetes Prevention Program (DPP) indicates that lifestyle change and metformin use in this population are clinically equivalent, each reducing the incidence of T2DM by approximately 50%. Shared decision making (SDM) is an attractive approach in this situation where several options are available. We can use a decision aid to make the decision explicit, describe the available options with equipoise, elicit patient preferences, and help patients make an informed decision that is right for them. There are no existing studies evaluating SDM for diabetes prevention among women with a history of GDM. Therefore, this study aims to test the effectiveness of an RCT evaluating SDM for diabetes prevention on weight loss among overweight/obese women with a history of GDM and hemoglobin A1c between 5.7-6.4%, as well as uptake of lifestyle change and/or metformin use and other patient-reported outcomes (e.g., physical activity, eating patterns, patient activation, health-related quality of life). The study will recruit 310 patients from two large health care systems (n=155 from UCLA Health and n=155 from Intermountain Healthcare) who will be randomized to either usual care or in-person shared decision making for diabetes prevention.

Keywords

Gestational Diabetes Mellitus Pre-diabetes Diabetes Mellitus, Type 2 Diabetes Prevention Shared Decision Making Diabetes, Gestational Diabetes Mellitus Prediabetic State Shared decision-making for diabetes prevention

Eligibility

You can join if…

Open to females ages 18-54

  • BMI 25 kg/m2 or above (23 or above if Asian American woman)
  • History of gestational diabetes mellitus
  • 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
  • Patient at UCLA or Intermountain Healthcare Systems with provider visit or labs in prior 12 months

You CAN'T join if...

  • Delivery within prior 12 months
  • History of diabetes (i.e., prior HbA1c 6.5% or above, or 2 or more fasting plasma glucose 125 or above, or prior diagnostic code)
  • Use of an anti-glycemic medication in prior 12 months
  • Last available glomerular filtration rate (eGFR) <45 ml/min
  • BMI >60 kg/m2
  • Bariatric surgery with prior 12 months
  • Active eating disorder
  • Currently pregnant or planning to get pregnant in the next 12-24 months
  • Currently breastfeeding
  • Completed a prediabetes SDM consult in past
  • Currently enrolled in a CDC recognized Diabetes Prevention Program (DPP)
  • Inability or concerns about doing >150 minutes of physical activity per week
  • History of metformin intolerance
  • Non-English primary language

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90024 United States
  • Intermountain Healthcare System accepting new patients
    Salt Lake City Utah 84103 United States

Lead Scientists at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04897945
Study Type
Interventional
Last Updated