SWEET: Postpartum Navigation After GDM

NCT04583839 | Completed

• 2 other identifiers: STU002123061R34DK125958
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postpartum weight retention

  Difference between 1) preconception weight and 2) weight at 1 year postpartum,

  1 year postpartum

Secondary Outcomes (10)

• Postpartum diabetes screening completion

  4-12 weeks postpartum

• Postpartum diabetes screening result

  4-12 weeks postpartum

• Abdominal circumference

  4-12 weeks and 1 year postpartum

• Blood pressure

  4-12 weeks and 1 year postpartum

• Postpartum visit attendance

  4-12 weeks postpartum

Other Outcomes (11)

• Participant experiences and perspectives on GDM

  4-12 weeks and 1 year postpartum

• Patient experiences with navigation

  4-12 weeks and 1 year postpartum

• Health care providers experiences with SWEET

  Through completion of study, an average of 2 years

Study Arms (2)

Navigation Group

EXPERIMENTAL

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

Non-navigation cohort

NO INTERVENTION

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

Interventions

Patient Navigation Program BEHAVIORAL

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.

Also known as: SWEET

Navigation Group

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Lynn M Yee, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology, Northwestern University

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 12, 2020
• Study Start: December 1, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)