Actively Recruiting

Phase Not Applicable
Age: 18Years - 44Years
FEMALE
ID04976881

Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial

Led by Northwestern University · Updated on 2025-11-18

840

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

N

Northwestern Memorial Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a strategy called PREPARED to improve knowledge and self-care among adult women with type 2 diabetes who are of reproductive age. The study focuses on enhancing understanding of reproductive risks and encouraging better management of diabetes during this important life stage. It aims to assess the impact of technology-based tools on health outcomes and reduce disparities compared to usual care. The PREPARED strategy uses electronic health record (EHR) technology during clinic visits to support medication checks, prompt providers to offer preconception counseling, and provide patient-friendly printed education materials. Following visits, participants receive daily text messages to encourage healthy lifestyle choices and reinforce diabetes self-management. The study compares this approach to usual care, which does not include these structured supports or reminders. Participants will engage in clinic visits where their medication use and reproductive planning will be reviewed. Researchers will measure changes in diabetes control markers like HbA1c, blood pressure, and cholesterol over six months, alongside improvements in knowledge and engagement with self-care activities such as diet, physical activity, medication adherence, contraceptive use, and folic acid intake. The study involves follow-up assessments at one, three, and six months to monitor outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 44Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Age 18 to 44 years
  • English or Spanish-speaking
  • Diagnosed with type 2 diabetes
  • Not currently pregnant
  • Not infecund, sterilized, or in a monogamous relationship with a sterilized partner
  • Have a private cell phone capable of receiving text messages
Not Eligible

You will not qualify if you...

  • Severe, uncorrectable vision, hearing, or cognitive impairments that would prevent study consent or participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 6 months

Participants engage in the PREPARED strategy, which includes reviewing medication lists, receiving provider counseling prompts, educational materials at clinic visits, and daily text messages to support diabetes self-care and preconception planning.

Clinic visits with patient education and counseling plus daily text messages for up to 6 months

Follow-up

Duration - Up to 6 months

Participants continue to be monitored for knowledge, self-care behaviors, and clinical outcomes such as HbA1c, blood pressure, and cholesterol.

Follow-up assessments at 1 month, 3 months, and 6 months

Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

S

Stacy Bailey, PhD MPH

G

Guisselle Wismer, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes.

Stacy C Bailey, Allison P Pack, Guisselle Wismer...

https://pubmed.ncbi.nlm.nih.gov/37940161