Shared Decision-Making Intervention for Gestational Diabetes

Recruiting at 1 trial location

Overseen By Richard Maranon

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Anti-glycemics, Metformin

Disqualifiers: Diabetes, Pregnancy, Bariatric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

310 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 10 11 12 13}

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

Tannaz Moin, MD,MBA,MSHS

Principal Investigator

University of California, Los Angeles

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).

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.

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

Group I: Shared decision-making with pharmacists Experimental Treatment 1 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 Care Active Control 1 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.

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

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Informed shared decision-making programme for patients with type 2 diabetes in primary care: cluster randomised controlled trial. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Shared decision making, satisfaction with care and medication adherence among patients with diabetes. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Culturally tailoring patient education and communication skills training to empower African-Americans with diabetes. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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]

7. England pubmed.ncbi.nlm.nih.gov

Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Educational Attainment, Decision-Making Preferences, and Interest in Evidence-Based Diabetes Prevention among Women with a History of Gestational Diabetes Mellitus. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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]

10. England pubmed.ncbi.nlm.nih.gov

Design and methods of a tailored approach for diabetes prevention in women with previous gestational diabetes. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

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 States pubmed.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]

13. England pubmed.ncbi.nlm.nih.gov

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]