SWEET: Sustaining Women's Engagement and Enabling Transitions After Gestational Diabetes Mellitus
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- Northwestern University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Postpartum weight retention
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Lynn M Yee
Assistant Professor, Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology, Northwestern University
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •Pregnancy delivering at or after 30 weeks of gestation, regardless of neonatal outcome
- •Gestational diabetes mellitus, treatment of any modality
- •English- or Spanish- speaker
- •Age 16 or greater
- •Established patient at the Northwestern Medicine obstetrics and gynecology practices
Exclusion Criteria
- •Intent to transfer prenatal care to an outside institution or leave Chicago region
- •Pre-gestational diabetes mellitus
- •Weight loss during pregnancy
- •History of bariatric surgery
- •Prior enrollment in SWEET
- •Enrollment in a concurrent research study that poses a potential conflict to the aims of SWEET or the other study
- •Health care provider participants:
- •Inclusion Criteria:
- •Age 18 or greater
- •English-speaking
Outcomes
Primary Outcomes
Postpartum weight retention
Time Frame: 1 year postpartum
Difference between 1) preconception weight and 2) weight at 1 year postpartum,
Secondary Outcomes
- Postpartum diabetes screening result(4-12 weeks postpartum)
- Postpartum diabetes screening completion(4-12 weeks postpartum)
- Abdominal circumference(4-12 weeks and 1 year postpartum)
- Postpartum visit attendance(4-12 weeks postpartum)
- Diabetes self-efficacy(4-12 weeks and 1 year postpartum)
- Patient activation(4-12 weeks and 1 year postpartum)
- Blood pressure(4-12 weeks and 1 year postpartum)
- Assessment of postpartum glycemic control(1 year postpartum)
- Postpartum transition to primary care(1 year postpartum)
- Diabetes risk perception(4-12 weeks and 1 year postpartum)