310 Participants Needed

Shared Decision-Making Intervention for Gestational Diabetes

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)

Trial Summary

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 data supports the effectiveness of the treatment Shared decision-making for diabetes prevention?

Research shows that shared decision-making can help women with a history of gestational diabetes choose effective strategies like lifestyle changes or medication to prevent type 2 diabetes. Additionally, shared decision-making has been linked to better satisfaction with care and improved health behaviors in diabetes management.12345

Is shared decision-making for gestational diabetes safe for humans?

The research does not provide specific safety data for shared decision-making interventions, but it suggests that shared decision-making is appropriate and preferred by many women with a history of gestational diabetes, indicating it is generally considered safe.16789

How is the shared decision-making treatment for gestational diabetes different from other treatments?

The shared decision-making treatment for gestational diabetes is unique because it involves patients actively participating in choosing their diabetes prevention strategy, such as lifestyle changes or medication, based on their personal preferences and needs. This approach empowers women with a history of gestational diabetes to make informed decisions, potentially increasing their engagement and success in preventing type 2 diabetes.110111213

What is the purpose of this trial?

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.

Research Team

TM

Tannaz Moin, MD,MBA,MSHS

Principal Investigator

University of California, Los Angeles

KD

Kenrik Duru, MD,MSHS

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Shared decision-making with pharmacistsExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
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.

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+

References

A randomized controlled trial of a shared decision making intervention for diabetes prevention for women with a history of gestational diabetes mellitus: The Gestational diabetes Risk Attenuation for New Diabetes (GRAND study). [2023]
Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial. [2019]
Informed shared decision-making programme for patients with type 2 diabetes in primary care: cluster randomised controlled trial. [2022]
Shared decision making, satisfaction with care and medication adherence among patients with diabetes. [2020]
Culturally tailoring patient education and communication skills training to empower African-Americans with diabetes. [2021]
Designing a data set for postpartum recall registry of women with gestational diabetes in recent pregnancy and its implementation in Iranian urban health centers. [2021]
Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol. [2020]
Educational Attainment, Decision-Making Preferences, and Interest in Evidence-Based Diabetes Prevention among Women with a History of Gestational Diabetes Mellitus. [2021]
Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey. [2022]
Design and methods of a tailored approach for diabetes prevention in women with previous gestational diabetes. [2022]
Comparing a telephone- and a group-delivered diabetes prevention program: Characteristics of engaged and non-engaged postpartum mothers with a history of gestational diabetes. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
A Randomized Study of Values Affirmation to Promote Interest in Diabetes Prevention Among Women With a History of Gestational Diabetes. [2020]
A kind reminder-A qualitative process evaluation of women's perspectives on receiving a reminder of type 2 diabetes follow-up screening after gestational diabetes. [2023]
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