SWEET: Postpartum Navigation After GDM

Study Overview
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Brief Summary
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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
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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.

Official Title
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SWEET: Sustaining Women's Engagement and Enabling Transitions After Gestational Diabetes Mellitus

Conditions
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Gestational Diabetes, Preventive Care / Anticipatory Guidance, Retention in Care, Postpartum Health, Lifestyle Modification

Intervention / Treatment
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* Behavioral: Patient Navigation Program


Participation Criteria
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Eligibility Criteria
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Patient Participants: 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 Obstetrician or advanced practitioner who has provided postpartum care to a participating SWEET participant OR primary care provider who has provided primary care to a participating SWEET participant

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two cohorts. One cohort will be provided intensive, individualized patient navigation services through one year postpartum, with a focus on diabetes prevention. The second cohort will receive usual care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation Group<br>Women who are randomized into SWEET will be assigned to a patient navigator. The navigator will meet women during hospitalization, at postpartum appointments, during primary care appointments, and as needed. At these face-to-face meetings, the navigator will perform education about the postpartum OGTT, post-GDM management plan, diabetes mellitus risks, lifestyle modification, and primary care transition. The navigator will facilitate the development of an individualized GDM Care Plan in conjunction with the patient and the medical team. The navigator will assess individual barriers to T2DM screening and prevention. At appointments, the navigator will also ensure a woman understands her diabetes-related care plan and will perform health education and barrier-reducing tasks as needed. | Behavioral: Patient Navigation Program<br>* 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.<br>* Other names: SWEET;|
| No Intervention: Non-navigation cohort<br>No navigation will be provided; women will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum weight retention | Difference between 1) preconception weight and 2) weight at 1 year postpartum, | 1 year postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum diabetes screening completion | Number of women with completion of a 2-hour oral glucose tolerance test by 12 weeks postpartum. | 4-12 weeks postpartum | 
| Postpartum diabetes screening result | Result of postpartum OGTT. | 4-12 weeks postpartum | 
| Abdominal circumference | Abdominal circumference at any time point in the first year after giving birth. | 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. | 4-12 weeks and 1 year postpartum | 
| Postpartum visit attendance | Attendance at a comprehensive postpartum care visit by 12 weeks postpartum. | 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. | 1 year postpartum | 
| Postpartum transition to primary care | Number of women with appointment made and kept for primary care by 1 year postpartum. | 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. | 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. | 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. | 4-12 weeks and 1 year postpartum |