TrialPath
← Back to searchRecruiting

Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes

NCT04976881 · Northwestern University
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial
About this study
Our Promoting REproductive Planning, And REadiness in Diabetes (PREPARED) strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among reproductive-aged, adult women with T2DM in primary care. Specifically, PREPARED will leverage electronic health record (EHR) technology at clinic visits to: \[1\] promote medication reconciliation and safety, \[2\] prompt patient-provider preconception counseling and reproductive planning, and \[3\] deliver low literacy print tools to reinforce counseling and promote goal-setting for diabetes self-care activities. Post-visit, a widely-available text messaging platforms will be used to: \[4\] encourage healthy lifestyle behaviors through goal-setting and daily reminders. Our randomized trial will assess the effectiveness and fidelity of a technology-based strategy to promote preconception care and diabetes self-management among women with type 2 diabetes in primary care. Aim 1: Test the effectiveness of PREPARED, compared to usual care, to improve patient: a) knowledge of reproductive risks associated with T2DM and recommended self-care activities b) engagement in self-care behaviors, including: i) diet, ii) physical activity, iii) adherence to diabetes medications; and use of iv) folic acid, and v) most or moderately effective contraception, when indicated; and c) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol. Aim 2: Assess whether PREPARED reduces disparities in the above outcomes versus usual care. Aim 3: Evaluate the fidelity of PREPARED to prompt medication reconciliation and preconception counseling, and to deliver patient education and post-visit support of diabetes self-care behaviors.
Eligibility criteria
Inclusion Criteria: * female * age 18-44 * English or Spanish-speaking * have a chart diagnosis of type 2 diabetes * not currently pregnant * not infecund, sterilized, or in a monogamous relationship with a sterilized partner * have a private cell phone with text messaging capability. Exclusion Criteria: * severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Study design
Enrollment target: 840 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2022-05-06
Estimated completion: 2026-05
Last updated: 2025-11-18
Interventions
Behavioral: Medication Reconciliation (MedRec) ToolBehavioral: Provider Alert and Decision SupportBehavioral: PREPSheetBehavioral: Text Messaging
Primary outcomes
  • Average difference in HbA1c values between Intervention and Control Patients (6 months)
  • Knowledge of reproductive risks (1 month)
Sponsor
Northwestern University · other
With: Northwestern Memorial Hospital, AllianceChicago
Contacts & investigators
ContactStacy Bailey, PhD MPH · contact · stacy-bailey@northwestern.edu · 312-503-5595
ContactGuisselle Wismer, MPH · contact · guisselle.wismer@northwestern.edu · 312-503-3272
InvestigatorStacy Bailey, PhD MPH · principal_investigator, Northwestern University
All locations (1)
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes · TrialPath