Diabetes, Gestational, Diabetes Mellitus, Type 2
Conditions
Keywords
Gestational Diabetes, Diabetes Mellitus, Type 2 Prevention, Preventive Health Services, Health Communication
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.
Interventions
BEHAVIORALStandard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
BEHAVIORALValues Affirmation (VA)
Interactive prompts to reflect on core personal values
BEHAVIORALTailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
BEHAVIORALMotivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
BEHAVIORALAction planning (AP)
Interactive prompts to problem solve challenges
Sponsors
University of California, Davis
Kaiser Foundation Research Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of recommended postpartum diabetes screening. | 4-12 weeks postpartum | Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan D Brown, PhD
University of California, Davis
Outcome results
None listed