Study to Understand Risk Information to Support and Empower (SUNRISE)
Status
Invitation-only
Conditions
Diabetes, Gestational
Diabetes Mellitus, Type 2
Treatments
Behavioral: Action planning (AP)
Behavioral: Tailored Risk Information (TRI)
Behavioral: Motivational Interviewing-based (MI)
Behavioral: Values Affirmation (VA)
Behavioral: Standard Health Information
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
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.
Enrollment
2,000 estimated patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Health Services Research
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
Triple Blind
2,000 participants in 16 patient groups
Condition 1
Experimental group
Description:
Standard health message + VA + TRI + MI+ AP
Treatment:
Behavioral: Standard Health Information
Behavioral: Values Affirmation (VA)
Behavioral: Motivational Interviewing-based (MI)
Behavioral: Tailored Risk Information (TRI)
Behavioral: Action planning (AP)
Condition 2
Experimental group
Description:
Standard health message + VA + TRI + MI
Treatment:
Behavioral: Standard Health Information
Behavioral: Values Affirmation (VA)
Behavioral: Motivational Interviewing-based (MI)
Behavioral: Tailored Risk Information (TRI)
Condition 3
Experimental group
Description:
Standard health message + VA + TRI + AP
Treatment:
Behavioral: Standard Health Information
Behavioral: Values Affirmation (VA)
Behavioral: Tailored Risk Information (TRI)
Behavioral: Action planning (AP)
Condition 4
Experimental group
Description:
Standard health message + VA + TRI
Treatment:
Behavioral: Standard Health Information
Behavioral: Values Affirmation (VA)
Behavioral: Tailored Risk Information (TRI)
Condition 5
Experimental group
Description:
Standard health message + VA + MI+ AP
Treatment:
Behavioral: Standard Health Information
Behavioral: Values Affirmation (VA)
Behavioral: Motivational Interviewing-based (MI)
Behavioral: Action planning (AP)
Condition 6
Experimental group
Description:
Standard health message + VA + MI
Treatment:
Behavioral: Standard Health Information
Behavioral: Values Affirmation (VA)
Behavioral: Motivational Interviewing-based (MI)
Condition 7
Experimental group
Description:
Standard health message + VA + AP
Treatment:
Behavioral: Standard Health Information
Behavioral: Values Affirmation (VA)
Behavioral: Action planning (AP)
Condition 8
Experimental group
Description:
Standard health message + VA
Treatment:
Behavioral: Standard Health Information
Behavioral: Values Affirmation (VA)
Condition 9
Experimental group
Description:
Standard health message + TRI + MI+ AP
Treatment:
Behavioral: Standard Health Information
Behavioral: Motivational Interviewing-based (MI)
Behavioral: Tailored Risk Information (TRI)
Behavioral: Action planning (AP)
Condition 10
Experimental group
Description:
Standard health message + TRI + MI
Treatment:
Behavioral: Standard Health Information
Behavioral: Motivational Interviewing-based (MI)
Behavioral: Tailored Risk Information (TRI)
Condition 11
Experimental group
Description:
Standard health message + TRI + AP
Treatment:
Behavioral: Standard Health Information
Behavioral: Tailored Risk Information (TRI)
Behavioral: Action planning (AP)
Condition 12
Experimental group
Description:
Standard health message + TRI
Treatment:
Behavioral: Standard Health Information
Behavioral: Tailored Risk Information (TRI)
Condition 13
Experimental group
Description:
Standard health message + MI+ AP
Treatment:
Behavioral: Standard Health Information
Behavioral: Motivational Interviewing-based (MI)
Behavioral: Action planning (AP)
Condition 14
Experimental group
Description:
Standard health message + MI
Treatment:
Behavioral: Standard Health Information
Behavioral: Motivational Interviewing-based (MI)
Condition 15
Experimental group
Description:
Standard health message + AP
Treatment:
Behavioral: Standard Health Information
Behavioral: Action planning (AP)
Condition 16
Experimental group
Description:
Standard health message
Treatment:
Behavioral: Standard Health Information
Trial contacts and locations
1
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