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Shared Decision-Making Intervention for Gestational Diabetes
N/A
Recruiting
Led By Kenrik Duru, MD,MSHS
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, and 24 months
Awards & highlights
Study Summary
This trial is testing whether shared decision making can help women with a history of gestational diabetes lose weight and adopt diabetes prevention strategies.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention focuses on shared decision-making rather than medication or invasive procedures, it's not expected to cause typical side effects. However, lifestyle changes involved might lead to temporary discomfort like muscle soreness from new physical activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had prediabetes in the last 3 years, confirmed by tests or diagnosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight change
Secondary outcome measures
Health-related quality of life
Uptake of DPP lifestyle program or metformin
Weight Change
Trial Design
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.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,377 Previous Clinical Trials
4,315,501 Total Patients Enrolled
Intermountain Health Care, Inc.OTHER
137 Previous Clinical Trials
1,962,800 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,538 Previous Clinical Trials
10,266,721 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You have had diabetes during pregnancy.I have had a consultation for prediabetes.I have a history of diabetes.I have been to UCLA or Intermountain Healthcare for a visit or labs in the last year.My primary language is not English.You are currently participating in a program to prevent diabetes that is recognized by the CDC.You have had bad reactions to metformin in the past.You have a body mass index (BMI) of 25 or higher (23 or higher if you are an Asian American woman).You currently have an eating disorder that is not under control.I had weight loss surgery within the last year.Gave birth in the last 12 months.I have had prediabetes in the last 3 years, confirmed by tests or diagnosis.You are unable to or worried about doing more than 150 minutes of physical activity each week.
Research Study Groups:
This trial has the following groups:- Group 1: Shared decision-making with pharmacists
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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