Study to Understand Risk Information to Support and Empower
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Health Information, Values Affirmation (VA), Tailored Risk Information (TRI), Motivational Interviewing-based (MI).
- Who it may be relevant to
- Registry conditions: Diabetes, Gestational, Diabetes Mellitus, Type 2. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Optimizing a Scalable Intervention to Maximize Guideline-recommended Diabetes Testing After GDM
Overview
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
- Behavioral Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention - Behavioral Values Affirmation (VA)
Interactive prompts to reflect on core personal values - Behavioral Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes - Behavioral Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing - Behavioral Action planning (AP)
Interactive prompts to problem solve challenges
Primary outcome measures
- Completion of recommended postpartum diabetes screening. [Time frame: 4-12 weeks postpartum]
Secondary outcome measures (3)
- Completion of any recommended postpartum diabetes screening test. [Time frame: 4-52 weeks postpartum]
- Completion of any recommended postpartum diabetes screening test. [Time frame: 4-12 weeks postpartum]
- Uptake of a lifestyle program for diabetes prevention. [Time frame: 4-52 weeks postpartum]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Triple blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Kaiser Permanente Northern California — Pleasanton
Identifiers
NCT: NCT05752292 · 1826240 · R01DK122087