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A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT04897945
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : October 20, 2021
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Intermountain Health Care, Inc.
Information provided by (Responsible Party):
Kenrik Duru, University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Pre-diabetes Diabetes Mellitus, Type 2 Behavioral: Shared decision-making for diabetes prevention Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
Actual Study Start Date : October 12, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Shared decision-making with pharmacists
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.
Behavioral: Shared decision-making for diabetes prevention
Pharmacists and/or nurses will engage patients with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) recognized diabetes prevention program (DPP), and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.

No Intervention: Usual Care
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.



Primary Outcome Measures :
  1. Weight change [ Time Frame: 12 months ]
    Proportion with >5% weight loss


Secondary Outcome Measures :
  1. Weight Change [ Time Frame: 24 months ]
    Proportion with >5% weight loss

  2. Uptake of DPP lifestyle program or metformin [ Time Frame: 6 months ]
    1) Attending at least 9 of 16 of weekly lifestyle change sessions OR 2) Taking metformin (yes/no)

  3. Health-related quality of life [ Time Frame: 6, 12, and 24 months ]
    Short-form (SF-36) measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04897945


Contacts
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Contact: Richard Maranon 310-206-4177 rmaranon@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Kenrik Duru, MD,MSHS         
Contact: Tannaz Moin, MD,MBA,MSHS         
United States, Utah
Intermountain Healthcare System Recruiting
Salt Lake City, Utah, United States, 84103
Contact: Kim Brunisholz, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Intermountain Health Care, Inc.
Investigators
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Principal Investigator: Kenrik Duru, MD,MSHS University of California, Los Angeles
Principal Investigator: Tannaz Moin, MD,MBA,MSHS University of California, Los Angeles
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Responsible Party: Kenrik Duru, Professor Of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04897945    
Other Study ID Numbers: IRB#20-001558
R01DK127733 ( U.S. NIH Grant/Contract )
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenrik Duru, University of California, Los Angeles:
Diabetes Prevention
Shared Decision Making
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications