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Online Intervention for Gestational Diabetes Postpartum Care (SUNRISE Trial)
N/A
Waitlist Available
Led By Susan D Brown, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 18 years and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-52 weeks postpartum
Awards & highlights
No Placebo-Only Group
Summary
This trial tests components of an online intervention to help women with GDM get postpartum screening and programs for diabetes prevention. It mixes standard health info with motivational and logistical help. It uses a randomized factorial study design.
Who is the study for?
This trial is for pregnant individuals aged 18 or older with gestational diabetes, who speak English and are in contact with the Kaiser Permanente Northern California's perinatal service. It excludes those currently hospitalized, with pregnancy loss, prior requests to avoid research invites, eating disorders, or pre-pregnancy diabetes.
What is being tested?
The study tests a digital health program designed to encourage postpartum screening and lifestyle changes for diabetes prevention. Participants receive standard health info plus up to four additional components like motivational interviewing and action planning using an interactive online platform.
What are the potential side effects?
Since this trial involves information-based interventions rather than medications, traditional side effects are not expected. However, participants may experience stress or anxiety related to receiving health risk information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-52 weeks postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-52 weeks postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Completion of recommended postpartum diabetes screening.
Secondary study objectives
Completion of any recommended postpartum diabetes screening test.
Uptake of a lifestyle program for diabetes prevention.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
16Treatment groups
Experimental Treatment
Group I: Condition 9Experimental Treatment4 Interventions
Standard health message + TRI + MI+ AP
Group II: Condition 8Experimental Treatment2 Interventions
Standard health message + VA
Group III: Condition 7Experimental Treatment3 Interventions
Standard health message + VA + AP
Group IV: Condition 6Experimental Treatment3 Interventions
Standard health message + VA + MI
Group V: Condition 5Experimental Treatment4 Interventions
Standard health message + VA + MI+ AP
Group VI: Condition 4Experimental Treatment3 Interventions
Standard health message + VA + TRI
Group VII: Condition 3Experimental Treatment4 Interventions
Standard health message + VA + TRI + AP
Group VIII: Condition 2Experimental Treatment4 Interventions
Standard health message + VA + TRI + MI
Group IX: Condition 16Experimental Treatment1 Intervention
Standard health message
Group X: Condition 15Experimental Treatment2 Interventions
Standard health message + AP
Group XI: Condition 14Experimental Treatment2 Interventions
Standard health message + MI
Group XII: Condition 13Experimental Treatment3 Interventions
Standard health message + MI+ AP
Group XIII: Condition 12Experimental Treatment2 Interventions
Standard health message + TRI
Group XIV: Condition 11Experimental Treatment3 Interventions
Standard health message + TRI + AP
Group XV: Condition 10Experimental Treatment3 Interventions
Standard health message + TRI + MI
Group XVI: Condition 1Experimental Treatment5 Interventions
Standard health message + VA + TRI + MI+ AP
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
943 Previous Clinical Trials
4,753,688 Total Patients Enrolled
7 Trials studying Diabetes
1,497 Patients Enrolled for Diabetes
Kaiser Foundation Research InstituteOTHER
27 Previous Clinical Trials
19,296 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,329,832 Total Patients Enrolled
109 Trials studying Diabetes
138,677 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You were diagnosed with diabetes before getting pregnant.The mother or baby is currently staying in the hospital.You have a history of an eating disorder.You are currently pregnant and have gestational diabetes.Previous miscarriage or stillbirth.You have been in touch with the Kaiser Permanente Northern California (KPNC) Regional Perinatal Service Center.
Research Study Groups:
This trial has the following groups:- Group 1: Condition 7
- Group 2: Condition 13
- Group 3: Condition 15
- Group 4: Condition 10
- Group 5: Condition 5
- Group 6: Condition 9
- Group 7: Condition 11
- Group 8: Condition 6
- Group 9: Condition 1
- Group 10: Condition 12
- Group 11: Condition 3
- Group 12: Condition 2
- Group 13: Condition 4
- Group 14: Condition 8
- Group 15: Condition 14
- Group 16: Condition 16
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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