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NCT Number: NCT04976881

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

This study is being done to investigate strategies that may improve patient's knowledge of type 2 diabetes during reproductive age and improve knowledge and engagement in self-care activities.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Electronic Health Record Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Primary Health Care Reproductive Behavior

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication Reconciliation (MedRec) Tool

Behavioral

Patients will receive a print MedRec tool, generated via the EHR, which includes a list of medications prescribed according to the patient record. Patients are asked to review this list, to add/remove drugs to reflect actual use, to note how they are taking each medication, and to describe any concerns.

Provider Alert and Decision Support

Behavioral

During the clinic visit, an automated, EHR alert will notify the provider that the patient is a woman of reproductive age with T2DM and should receive counseling on the importance of glycemic control, the use of contraception until glycemic control is achieved, and the benefits of folic acid.

PREPSheet

Behavioral

When patients leave an encounter, they will receive a patient-friendly educational material (a.k.a. the PREPSheet) that reviews potential risks of pregnancy in the context of T2DM and highlights the importance of: 1) achieving glycemic control through diabetes self-care, 2) using effective contraception until glycemic control is achieved and pregnancy is desired, 3) discussing medication use with a provider if planning or becoming pregnant, and 4) taking folic acid daily to reduce increased risk of neural tube defects.

Text messaging

Behavioral

Within ~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.

Primary outcomes

  1. Average difference in HbA1c values between Intervention and Control Patients

    Time frame: 6 months

    We will abstract HbA1c values from performance sites EHRs to investigate effects of PREPARED.

  2. Knowledge of reproductive risks

    Time frame: 1 month

    We will use a questionnaire, developed by our team and the scientific literature, to evaluate patient knowledge of reproductive risks and recommended health behaviors for women with type 2 diabetes. It includes items assessing knowledge of pregnancy planning, reproductive risks, and desired diabetes self-care behaviors. Correctly answered questions will be summed and a total knowledge score will be generated. Higher scores indicate greater knowledge.

Secondary outcomes

  1. Average difference in blood pressure values between Intervention and Control Patients

    Time frame: 6 months

    We will abstract blood pressure values (systolic and diastolic) from performance sites EHRs to investigate effects of PREPARED.

  2. Average difference in cholesterol values between Intervention and Control Patients

    Time frame: 6 months

    We will abstract cholesterol values from performance sites EHRs to investigate effects of PREPARED.

  3. Engagement in diabetes self-care activities

    Time frame: at 1 month and 3 months

    We will use the validated Summary of Diabetes Self Care Activities (SDSCA) measure. Scores range from 0 to 7 for each domain, with higher scores reflect greater engagement.

  4. Contraceptive use

    Time frame: at 1 month and 3 months

    we will use validated items to assess patient contraceptive use, which is categorized into use of a 'most or moderately effective' form of contraception or 'less effective/no contraception'

  5. Folic acid use

    Time frame: at 1 month and 3 months

    Patients are asked if they have taken folic acid supplements or a vitamin containing folic acid over the past month (yes/no).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • AllianceChicago
  • Northwestern Memorial Hospital

Registry information

Official study title

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

Acronym: PREPARED

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 26, 2021
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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