Study to Understand Risk Information to Support and Empower

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Diabetes, Gestational

• Registration Number: NCT05752292
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-02
• Study Start: 2023-04-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-09
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Completion of recommended postpartum diabetes screening.	4-12 weeks postpartum	Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Name	Time	Method
Completion of any recommended postpartum diabetes screening test.	4-52 weeks postpartum	Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c)
Uptake of a lifestyle program for diabetes prevention.	4-52 weeks postpartum	Enrollment in a lifestyle program for diabetes prevention among women without type 2 diabetes mellitus according to any screening result

Trial Locations

Locations (1)

Kaiser Permanente Northern California; 🇺🇸 Pleasanton, California, United States