This study is a pilot assessment of Sustaining Women's Engagement and Enabling Transitions after GDM (SWEET), a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with gestational diabetes mellitus. The investigators aim to determine, via a randomized controlled trial of 40 women who have had GDM, whether those who receive the navigation intervention have improved diabetes-related health at 1 year after birth compared to those who receive usual care. The SWEET intervention will provide GDM-specific, individualized navigation services that leverage existing clinical infrastructure, including logistical support, psychosocial support, and health education, through 1-year postpartum. Participants will undergo surveys, interviews, and medical record review at multiple time points. The investigators will also conduct qualitative interviews with clinical providers.
Gestational diabetes mellitus (GDM) poses a substantial long-term health burden to women due to the 7-fold increased risk of developing type 2 diabetes mellitus (T2DM) and other cardiovascular disorders. Yet, there are many gaps in the transition period after GDM, which is a particularly critical time due to enhanced motivation and access. Nevertheless, a minority of women receive postpartum screening for dysglycemia or have successful transition to primary care. Although T2DM prevention interventions can be successful, they cannot be deployed without retention and engagement in care. Addressing the unique barriers experienced by postpartum women requires innovative models of health care delivery to promote prevention of T2DM after GDM. One potential intervention with demonstrated successes in other arenas is patient navigation, a barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services. This protocol is to perform a pilot assessment of Sustaining Women's Engagement and Enabling Transitions after GDM (SWEET), a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with GDM. The investigators aim to determine, via a randomized controlled trial of 40 women who have had GDM, whether those who receive the SWEET navigation intervention have improved diabetes-related health at 1 year after birth compared to those who receive usual care. In order to promote self-efficacy, enhance access, and sustain long-term engagement, the SWEET intervention will provide GDM-specific, individualized navigation services that leverage existing clinical infrastructure, including logistical support, psychosocial support, and health education, through 1-year postpartum. Aim 1 will evaluate whether clinical (weight, glycemic control, abdominal circumference, and blood pressure), health services (postpartum and primary care visit attendance), and patient-reported (diabetes self-efficacy, activation, and T2DM risk perception) outcomes differ in women exposed to SWEET versus usual care. Aim 2 will evaluate feasibility and acceptability. This proposal will generate key data for the conduct of a full-scale trial of a GDM-specific postpartum patient navigation program that will address critical questions about long-term maternal health and T2DM prevention. SWEET bridges the chasm between care during pregnancy - focused on improving the health of the pregnant woman and her offspring - and long-term women's health care - focused on chronic disease management and preventive health. The long-term goals are to understand how to optimize long-term health after GDM in order to prevent or ameliorate the effects of T2DM beyond the perinatal period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
SWEET is a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with GDM. Women in SWEET will receive GDM-specific, tapered, individualized navigation services, including logistical support, psychosocial support, and patient education, through 1-year postpartum.
Northwestern Memorial Hospital
Chicago, Illinois, United States
Postpartum weight retention
Difference between 1) preconception weight and 2) weight at 1 year postpartum,
Time frame: 1 year postpartum
Postpartum diabetes screening completion
Number of women with completion of a 2-hour oral glucose tolerance test by 12 weeks postpartum.
Time frame: 4-12 weeks postpartum
Postpartum diabetes screening result
Result of postpartum OGTT.
Time frame: 4-12 weeks postpartum
Abdominal circumference
Abdominal circumference at any time point in the first year after giving birth.
Time frame: 4-12 weeks and 1 year postpartum
Blood pressure
Blood pressure at any time point in the first year after giving birth and proportion with hypertension.
Time frame: 4-12 weeks and 1 year postpartum
Postpartum visit attendance
Attendance at a comprehensive postpartum care visit by 12 weeks postpartum.
Time frame: 4-12 weeks postpartum
Assessment of postpartum glycemic control
Number of women who complete any measure of glycemic control (fasting glucose, random glucose, and/or hemoglobin A1c) by 1 year postpartum.
Time frame: 1 year postpartum
Postpartum transition to primary care
Number of women with appointment made and kept for primary care by 1 year postpartum.
Time frame: 1 year postpartum
Diabetes self-efficacy
Diabetes Empowerment Scale (DES)- Minimum score is 1, and maximum score is 5. Higher scores indicate greater levels of diabetes self-efficacy.
Time frame: 4-12 weeks and 1 year postpartum
Patient activation
Patient Activation Measure (PAM)- Patient knowledge, skill, and confidence for managing one's own health and healthcare. Minimum score is 1, and maximum score is 100. Higher scores indicate higher activation levels in self-management.
Time frame: 4-12 weeks and 1 year postpartum
Diabetes risk perception
Risk Perception Survey for Developing Diabetes (RPS-DD)- adapted for women with gestational diabetes- Scores are averaged with higher scores indicating a greater personal control to prevent development of DM. Minimum score of 1, and maximum score of 5. Higher scores indicate greater personal control beliefs.
Time frame: 4-12 weeks and 1 year postpartum
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