SWEET: Postpartum Navigation After GDM

Not Applicable

Completed

• Conditions: Retention in Care; Preventive Care / Anticipatory Guidance; Gestational Diabetes; Postpartum Health; Lifestyle Modification
• Interventions: Behavioral: Patient Navigation Program

• Registration Number: NCT04583839
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-12
• Study Start: 2020-12-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigation Group	Patient Navigation Program	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.

Primary Outcome Measures

Name	Time	Method
Postpartum weight retention	1 year postpartum	Difference between 1) preconception weight and 2) weight at 1 year postpartum,

Secondary Outcome Measures

Name	Time	Method
Postpartum diabetes screening result	4-12 weeks postpartum	Result of postpartum OGTT.
Postpartum diabetes screening completion	4-12 weeks postpartum	Number of women with completion of a 2-hour oral glucose tolerance test by 12 weeks postpartum.
Abdominal circumference	4-12 weeks and 1 year postpartum	Abdominal circumference at any time point in the first year after giving birth.
Postpartum visit attendance	4-12 weeks postpartum	Attendance at a comprehensive postpartum care visit by 12 weeks postpartum.
Diabetes self-efficacy	4-12 weeks and 1 year postpartum	Diabetes Empowerment Scale (DES)- Minimum score is 1, and maximum score is 5. Higher scores indicate greater levels of diabetes self-efficacy.
Patient activation	4-12 weeks and 1 year postpartum	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.
Blood pressure	4-12 weeks and 1 year postpartum	Blood pressure at any time point in the first year after giving birth and proportion with hypertension.
Assessment of postpartum glycemic control	1 year postpartum	Number of women who complete any measure of glycemic control (fasting glucose, random glucose, and/or hemoglobin A1c) by 1 year postpartum.
Postpartum transition to primary care	1 year postpartum	Number of women with appointment made and kept for primary care by 1 year postpartum.
Diabetes risk perception	4-12 weeks and 1 year postpartum	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.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States