SWEET: Postpartum Navigation After GDM

Northwestern University

Status: Completed

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

Treatments: Behavioral: Patient Navigation Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04583839

STU00212306

1R34DK125958 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Navigation Group

Experimental group

Description:

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.

Treatment:

Behavioral: Patient Navigation Program

Non-navigation cohort

No Intervention group

Description:

No navigation will be provided; women will receive usual care.