Study to Understand Risk Information to Support and Empower
Part of paid clinical trials in Pleasanton, California.
- Sponsor
- University of California, Davis
- Study ID
- NCT05752292
- Status
- Enrolling By Invitation
Conditions
- Diabetes Mellitus, Type 2
- Diabetes, Gestational
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Standard Health Information — BEHAVIORALStandard health information about postpartum screening and lifestyle programs for diabetes prevention
- Values Affirmation (VA) — BEHAVIORALInteractive prompts to reflect on core personal values
- Tailored Risk Information (TRI) — BEHAVIORALInteractive prompts to provide tailored information on risk factors for type 2 diabetes
- Motivational Interviewing-based (MI) — BEHAVIORALInteractive prompts based on principles of motivational interviewing
- Action planning (AP) — BEHAVIORALInteractive prompts to problem solve challenges
Study Details
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.
Key Dates
- Start date
- Apr 13, 2023
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 2,000 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Condition 1Standard health message + VA + TRI + MI+ AP
- Experimental: Condition 2Standard health message + VA + TRI + MI
- Experimental: Condition 3Standard health message + VA + TRI + AP
- Experimental: Condition 4Standard health message + VA + TRI
- Experimental: Condition 5Standard health message + VA + MI+ AP
- Experimental: Condition 6Standard health message + VA + MI
- Experimental: Condition 7Standard health message + VA + AP
- Experimental: Condition 8Standard health message + VA
- Experimental: Condition 9Standard health message + TRI + MI+ AP
- Experimental: Condition 10Standard health message + TRI + MI
- Experimental: Condition 11Standard health message + TRI + AP
- Experimental: Condition 12Standard health message + TRI
- Experimental: Condition 13Standard health message + MI+ AP
- Experimental: Condition 14Standard health message + MI
- Experimental: Condition 15Standard health message + AP
- Experimental: Condition 16Standard health message
Primary Outcome Measure
Completion of recommended postpartum diabetes screening. [ Time Frame: 4-12 weeks postpartum ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kaiser Permanente Northern California | Pleasanton | California | 94588 | - |
Find similar trials in Pleasanton, CA
By condition
By specialty
By research site
Related Studies
- Use of CGM in Kidney Transplant RecipientsRecruiting · University of California, Davis · Sacramento, California
- DETERMINE: Detemir vs NPHPHASE2 · Recruiting · University of California, Los Angeles · Los Angeles, California
- Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin ResistanceRecruiting · Stanford University · Stanford, California
- Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic PopulationRecruiting · San Diego State University · San Diego, California