Clinical trial NCT04583839: SWEET: Postpartum Navigation After GDM
Official title: SWEET: Sustaining Women's Engagement and Enabling Transitions After Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Preventive Care / Anticipatory Guidance
Retention in Care
Postpartum Health
Lifestyle Modification
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-10-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Postpartum weight retention
timeFrame: 1 year postpartum
Secondary outcomes:
measure: Postpartum diabetes screening completion
timeFrame: 4-12 weeks postpartum
measure: Postpartum diabetes screening result
timeFrame: 4-12 weeks postpartum
measure: Abdominal circumference
timeFrame: 4-12 weeks and 1 year postpartum
measure: Blood pressure
timeFrame: 4-12 weeks and 1 year postpartum
measure: Postpartum visit attendance
timeFrame: 4-12 weeks postpartum
measure: Assessment of postpartum glycemic control
timeFrame: 1 year postpartum
measure: Postpartum transition to primary care
timeFrame: 1 year postpartum
measure: Diabetes self-efficacy
timeFrame: 4-12 weeks and 1 year postpartum
measure: Patient activation
timeFrame: 4-12 weeks and 1 year postpartum
measure: Diabetes risk perception
timeFrame: 4-12 weeks and 1 year postpartum
Other outcomes:
measure: Participant experiences and perspectives on GDM
timeFrame: 4-12 weeks and 1 year postpartum
measure: Patient experiences with navigation
timeFrame: 4-12 weeks and 1 year postpartum
measure: Health care providers experiences with SWEET
timeFrame: Through completion of study, an average of 2 years
measure: Patient satisfaction with logistical aspects of navigation
timeFrame: 4-12 weeks and 1 year postpartum
measure: Patient satisfaction with interpersonal relationship with navigator
timeFrame: 4-12 weeks and 1 year postpartum
measure: Proportion of eligible participants who enroll
timeFrame: Through completion of study, an average of 2 years
measure: Recruitment rate
timeFrame: Through completion of study, an average of 2 years
measure: Time to enrollment
timeFrame: Through completion of study, an average of 2 years
measure: Dropout rate
timeFrame: Through completion of study, an average of 2 years
measure: Retention rate
timeFrame: Through completion of study, an average of 2 years
measure: Participant adherence with navigation
timeFrame: Through completion of study, an average of 2 years
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Lynn M Yee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: