Clinical trial NCT04897945: A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
Official title: A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus
Pre-diabetes
Diabetes Mellitus, Type 2
Keywords: Diabetes Prevention
Shared Decision Making
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Intermountain Health Care, Inc.
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-05-24
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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
* 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

Primary outcomes:
measure: Weight change
timeFrame: 12 months
Secondary outcomes:
measure: Weight Change
timeFrame: 24 months
measure: Uptake of DPP lifestyle program or metformin
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6, 12, and 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Salt Lake City
country: United States
facility: Intermountain Healthcare System
state: Utah
Study officials:
affiliation: University of California, Los Angeles
name: Kenrik Duru, MD,MSHS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Tannaz Moin, MD,MBA,MSHS
role: PRINCIPAL_INVESTIGATOR
References: