Study to Understand Risk Information to Support and Empower
Not Applicable
- Conditions
- Diabetes Mellitus, Type 2Diabetes, Gestational
- Interventions
- Behavioral: Standard Health InformationBehavioral: Values Affirmation (VA)Behavioral: Motivational Interviewing-based (MI)Behavioral: Tailored Risk Information (TRI)Behavioral: Action planning (AP)
- 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
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
- Arm && Interventions
Group Intervention Description Condition 6 Values Affirmation (VA) Standard health message + VA + MI Condition 1 Action planning (AP) Standard health message + VA + TRI + MI+ AP Condition 7 Action planning (AP) Standard health message + VA + AP Condition 10 Motivational Interviewing-based (MI) Standard health message + TRI + MI Condition 1 Values Affirmation (VA) Standard health message + VA + TRI + MI+ AP Condition 1 Tailored Risk Information (TRI) Standard health message + VA + TRI + MI+ AP Condition 4 Values Affirmation (VA) Standard health message + VA + TRI Condition 1 Standard Health Information Standard health message + VA + TRI + MI+ AP Condition 6 Standard Health Information Standard health message + VA + MI Condition 1 Motivational Interviewing-based (MI) Standard health message + VA + TRI + MI+ AP Condition 3 Values Affirmation (VA) Standard health message + VA + TRI + AP Condition 3 Action planning (AP) Standard health message + VA + TRI + AP Condition 5 Action planning (AP) Standard health message + VA + MI+ AP Condition 2 Values Affirmation (VA) Standard health message + VA + TRI + MI Condition 2 Motivational Interviewing-based (MI) Standard health message + VA + TRI + MI Condition 3 Standard Health Information Standard health message + VA + TRI + AP Condition 3 Tailored Risk Information (TRI) Standard health message + VA + TRI + AP Condition 2 Standard Health Information Standard health message + VA + TRI + MI Condition 4 Standard Health Information Standard health message + VA + TRI Condition 4 Tailored Risk Information (TRI) Standard health message + VA + TRI Condition 5 Motivational Interviewing-based (MI) Standard health message + VA + MI+ AP Condition 7 Values Affirmation (VA) Standard health message + VA + AP Condition 8 Values Affirmation (VA) Standard health message + VA Condition 9 Motivational Interviewing-based (MI) Standard health message + TRI + MI+ AP Condition 11 Standard Health Information Standard health message + TRI + AP Condition 13 Standard Health Information Standard health message + MI+ AP Condition 13 Motivational Interviewing-based (MI) Standard health message + MI+ AP Condition 2 Tailored Risk Information (TRI) Standard health message + VA + TRI + MI Condition 11 Action planning (AP) Standard health message + TRI + AP Condition 14 Motivational Interviewing-based (MI) Standard health message + MI Condition 15 Standard Health Information Standard health message + AP Condition 7 Standard Health Information Standard health message + VA + AP Condition 8 Standard Health Information Standard health message + VA Condition 9 Standard Health Information Standard health message + TRI + MI+ AP Condition 9 Tailored Risk Information (TRI) Standard health message + TRI + MI+ AP Condition 9 Action planning (AP) Standard health message + TRI + MI+ AP Condition 12 Standard Health Information Standard health message + TRI Condition 13 Action planning (AP) Standard health message + MI+ AP Condition 5 Standard Health Information Standard health message + VA + MI+ AP Condition 5 Values Affirmation (VA) Standard health message + VA + MI+ AP Condition 6 Motivational Interviewing-based (MI) Standard health message + VA + MI Condition 10 Standard Health Information Standard health message + TRI + MI Condition 10 Tailored Risk Information (TRI) Standard health message + TRI + MI Condition 11 Tailored Risk Information (TRI) Standard health message + TRI + AP Condition 12 Tailored Risk Information (TRI) Standard health message + TRI Condition 14 Standard Health Information Standard health message + MI Condition 15 Action planning (AP) Standard health message + AP Condition 16 Standard Health Information Standard health message
- 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
🇺🇸Oakland, California, United States