Promoting Preconception Care and Diabetes Self-Management among Reproductive-Aged Women with Diabetes: The PREPARED Trial

ABSTRACT
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.
More than 30 million people in the U.S. have diabetes and 1 in 3 adults are projected to have the disease by
2050. While diabetes has historically affected older individuals, its incidence is increasing rapidly among younger
adults, including women of reproductive age (18-44 years). Women with early-onset type 2 diabetes (T2DM) are
at higher risk of cardiovascular-related morbidity and mortality and adverse reproductive outcomes, including
congenital anomalies and perinatal mortality. Achieving glycemic control is essential to reducing these risks.
As half of all pregnancies are unintended, clinical guidelines recommend providers routinely engage all women
of reproductive age in preconception care. For women with T2DM, this includes: 1) achieving glycemic control
through diabetes self-care, 2) using effective contraception until glycemic control is achieved and pregnancy is
desired, 3) discontinuing use of teratogenic medications if pregnancy could occur, 4) taking folic acid daily to
reduce increased risk of neural tube defects and 5) managing cardiovascular and other T2DM-related risks.
Despite these recommendations, up to 80% of women with T2DM do not receive preconception counseling.
Provider time limitations are often cited as a barrier, as is a lack of available resources.
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. PREPARED will leverage
electronic health record technology at clinic visits to: [1] promote medication reconciliation and safety, [2] prompt
provider preconception counseling, and [3] deliver low literacy print tools to reinforce counseling and promote
diabetes self-care. Post-visit, text messaging will be used to: [4] encourage healthy lifestyle behaviors.
We will conduct a randomized trial at multiple primary care practices among English and Spanish-speaking
women, age 18-44, with T2DM (N=840; n=420 per arm). Our study aims are to: 1) test the effectiveness of
PREPARED, compared to usual care, to improve patient knowledge of reproductive risks, engagement in
diabetes self-care behaviors, and glycemic control; 2) assess whether PREPARED reduces disparities in these
outcomes versus usual care; and 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.

Grant Number: 5R01DK127184-05
NIH Institute/Center: NIH
Principal Investigator: Stacy Bailey