Improving diabetes care and preconception planning for women with type 2 diabetes
Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial
This study tests a new approach using technology to help women with type 2 diabetes better manage their health and prepare for pregnancy compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04976881 on ClinicalTrials.gov |
What this trial studies
This study investigates strategies to enhance knowledge and engagement in self-care activities among reproductive-aged women with type 2 diabetes. The PREPARED strategy utilizes electronic health records and consumer technologies to integrate preconception care into primary health care. It includes medication reconciliation, provider alerts for counseling, and text messaging for lifestyle encouragement. The randomized trial will compare the effectiveness of this technology-based approach to usual care in improving self-care behaviors and clinical measures.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-44 with a diagnosis of type 2 diabetes who are not currently pregnant and can engage with text messaging.
Not a fit: Patients with severe vision, hearing, or cognitive impairments that prevent participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve diabetes management and reproductive health outcomes for women with type 2 diabetes.
How similar studies have performed: Other studies have shown success in using technology to improve diabetes management, making this approach promising but not entirely novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Stacy Bailey, PhD MPH — Northwestern University
- Study coordinator: Stacy Bailey, PhD MPH
- Email: stacy-bailey@northwestern.edu
- Phone: 312-503-5595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.