Shared Decision-Making Intervention for Gestational Diabetes

Not currently recruiting at 1 trial location
AG
RM
Overseen ByRichard Maranon
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a shared decision-making approach with pharmacists can help women who have had gestational diabetes (a type of diabetes that occurs during pregnancy) better manage their weight and reduce their risk of developing type 2 diabetes. The trial includes two groups: one will receive the shared decision-making intervention, and the other will receive usual care. Women who have had gestational diabetes, experienced prediabetes in the last three years, and are dealing with weight issues might be a good fit for this study. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could improve future care for women facing similar health challenges.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used anti-glycemic medications in the past 12 months.

What prior data suggests that this shared decision-making intervention is safe for diabetes prevention?

Research has shown that shared decision-making for preventing diabetes is generally well-received. Studies have found that this approach helps women who have had gestational diabetes (a type of diabetes during pregnancy) make informed health choices.

These studies have not identified any serious side effects from shared decision-making itself. Instead, they emphasize how this method can empower patients to lead healthier lives, reducing their risk of developing type 2 diabetes.

In summary, shared decision-making for diabetes prevention appears safe and has been successfully used to support better health decisions.12345

Why are researchers excited about this trial?

Researchers are excited about this shared decision-making intervention for gestational diabetes because it empowers patients by involving them directly in their diabetes care alongside pharmacists. Unlike standard care, which primarily involves routine check-ups and general guidance, this approach focuses on personalized care plans and active collaboration between patients and healthcare providers. By integrating pharmacists into the decision-making process, this method aims to improve adherence to prevention strategies and enhance patient outcomes, offering a more tailored and engaging way to manage gestational diabetes risk.

What evidence suggests that shared decision-making for diabetes prevention is effective for women with a history of gestational diabetes?

Research shows that shared decision-making (SDM) can assist women who had gestational diabetes (GDM) and are at risk of developing type 2 diabetes. Studies have found that SDM increases awareness of choices and encourages adherence to healthy habits to prevent diabetes. For instance, SDM can lead to better weight loss and the use of proven methods to reduce diabetes risk. In this trial, participants in the intervention arm will engage in SDM with pharmacists, which studies have shown improves outcomes, such as planning exercise for women with GDM. This approach involves working closely with healthcare providers to make informed decisions that fit individual needs.12367

Who Is on the Research Team?

KD

Kenrik Duru, MD,MSHS

Principal Investigator

University of California, Los Angeles

TM

Tannaz Moin, MD,MBA,MSHS

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have had diabetes during pregnancy.
I have been to UCLA or Intermountain Healthcare for a visit or labs in the last year.
You have a body mass index (BMI) of 25 or higher (23 or higher if you are an Asian American woman).
See 1 more

Exclusion Criteria

My kidney function is reduced, with an eGFR below 45 ml/min.
I have taken medication for blood sugar control in the last year.
My BMI is over 60 kg/m2.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline survey and have their weight recorded

1 visit
1 visit (in-person)

Intervention

Participants receive a pharmacist-coordinated shared decision making intervention

6 months
Follow-up visits at 6, 12, and 24 months

Follow-up

Participants are monitored for weight change and uptake of lifestyle changes or metformin use

24 months
Research assessments at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Shared decision-making for diabetes prevention
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Shared decision-making with pharmacistsExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Intermountain Health Care, Inc.

Collaborator

Trials
142
Recruited
1,965,000+

Citations

A randomized controlled trial of a shared decision making ...This study aims to test whether shared decision making (SDM) can help women with a history of GDM increase adoption of evidence-based strategies and lose weight ...
Effectiveness of Shared Decision-making for Diabetes ...Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned ...
A Shared Decision Making Intervention for Diabetes ...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 ...
Decision-making behavior of blood glucose management and ...This study aimed to investigate the decision-making behavior of blood glucose management and its influencing factors among pregnant women with gestational ...
Effect of a Shared Decision-Making-Based Exercise ...To analyze the application of a shared decision-making (SDM)-based exercise management program in patients with gestational diabetes mellitus (GDM) and its ...
Effect of a Shared Decision-Making-Based Exercise ...This study constructs an individualized exercise management plan based on Shared Decision-Making (SDM) and explores its application in patients ...
15. Management of Diabetes in Pregnancy: Standards of Care ...Statins can be considered in a shared decision-making process ... gestational diabetes: the Diabetes Prevention Program outcomes study 10-year ...
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