Diabetes Mellitus, Type 2 Clinical Trial
— SUNRISEOfficial title:
Optimizing a Scalable Intervention to Maximize Guideline-recommended Diabetes Testing After GDM
| Verified date | May 2024 |
| Source | University of California, Davis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.
| Status | Enrolling by invitation |
| Enrollment | 2000 |
| Est. completion date | February 2026 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Current pregnancy complicated by gestational diabetes mellitus (GDM) - Age: 18 years and older - Contact with the Kaiser Permanente Northern California (KPNC) Regional Perinatal Service Center - Able to communicate in English Exclusion Criteria: - Diagnosis of diabetes before pregnancy - Maternal or infant current hospitalization - Pregnancy loss - History of eating disorder - Previously requested not to receive research invitations |
| Country | Name | City | State |
|---|---|---|---|
| United States | Kaiser Permanente Northern California | Oakland | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Davis | Kaiser Foundation Research Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Completion of recommended postpartum diabetes screening. | Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT) | 4-12 weeks postpartum | |
| Secondary | Completion of any recommended postpartum diabetes screening test. | Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c) | 4-52 weeks postpartum | |
| Secondary | Uptake of a lifestyle program for diabetes prevention. | Enrollment in a lifestyle program for diabetes prevention among women without type 2 diabetes mellitus according to any screening result | 4-52 weeks postpartum |
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