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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04897945
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Intermountain Health Care, Inc. (Other)
310
2
2
59.6
155
2.6

Study Details

Study Description

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
  • Behavioral: Shared decision-making for diabetes prevention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 12, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Weight change [12 months]

    Proportion with >5% weight loss

Secondary Outcome Measures

  1. Weight Change [24 months]

    Proportion with >5% weight loss

  2. Uptake of DPP lifestyle program or metformin [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 [6, 12, and 24 months]

    Short-form (SF-36) measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 54 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Los Angeles Los Angeles California United States 90024
2 Intermountain Healthcare System Salt Lake City Utah United States 84103

Sponsors and Collaborators

  • University of California, Los Angeles
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Intermountain Health Care, Inc.

Investigators

  • Principal Investigator: Kenrik Duru, MD,MSHS, University of California, Los Angeles
  • Principal Investigator: Tannaz Moin, MD,MBA,MSHS, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kenrik Duru, Professor Of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT04897945
Other Study ID Numbers:
  • IRB#20-001558
  • R01DK127733
First Posted:
May 24, 2021
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kenrik Duru, Professor Of Medicine, University of California, Los Angeles
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2021