SWEET: Postpartum Navigation After GDM

Gestational Diabetes Clinical Trial

— SWEET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04583839
• Other study ID #: STU00212306
• Secondary ID: 1R34DK125958
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 31, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Patient Navigation Program
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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant experiences and perspectives on GDM	Qualitative feedback on experience with the GDM diagnosis, barriers to obtaining postpartum GDM-related care, and barriers and facilitators of the primary care transition.	4-12 weeks and 1 year postpartum
Other	Patient experiences with navigation	Participants who are randomized to receive navigation will complete in-depth interviews about experiences with the program and areas for improvement.	4-12 weeks and 1 year postpartum
Other	Health care providers experiences with SWEET	Health care providers whose patients participate in the trial will undergo in-depth interviews about provider perceptions of the program, barriers to providing optimal care for women who have had GDM, the methods by which providers and the health care system can adopt postpartum care recommendations, and how to optimize SWEET for future study.	Through completion of study, an average of 2 years
Other	Patient satisfaction with logistical aspects of navigation	Patient Satisfaction with Logistical Aspects of Navigation (PSN-L)- Participants randomized to navigation will complete surveys designed to understand their logistical experiences with patient navigation. Minimum score is 0, and maximum score is 78. Higher scores indicate higher levels of satisfaction.	4-12 weeks and 1 year postpartum
Other	Patient satisfaction with interpersonal relationship with navigator	Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I)- Participants randomized to navigation will complete surveys designed to understand their interpersonal experiences with patient navigation. Minimum score is 0, and maximum score is 45. Higher scores indicate higher levels of satisfaction.	4-12 weeks and 1 year postpartum
Other	Proportion of eligible participants who enroll	Proportion of eligible participants who enroll will be defined as the proportion of women who enroll out of all approached, eligible women.	Through completion of study, an average of 2 years
Other	Recruitment rate	Recruitment rate will be defined as the number of women successfully enrolled per week during the study, using mean or median to illustrate the variation of the numbers.	Through completion of study, an average of 2 years
Other	Time to enrollment	Time to enrollment will be defined as the number of months to enroll target sample size.	Through completion of study, an average of 2 years
Other	Dropout rate	Dropout rate will be defined as the number of enrolled women who drop out of study participation during the 1-year follow-up per week.	Through completion of study, an average of 2 years
Other	Retention rate	Retention rate will be defined as the proportion of enrolled women who successfully complete all study visits during 1-year follow-up period.	Through completion of study, an average of 2 years
Other	Participant adherence with navigation	The participant adherence (engagement rate) outcomes will be calculated both as a proportion (percent of navigator-attempted contacts with response) and count (number of navigator-attempted contacts with response) among participants randomized to navigation. Feasibility targets will be defined as 80% recruitment, retention, and adherence rates. Targets are set at 80% based on prior literature using this threshold to represent greater engagement.	Through completion of study, an average of 2 years
Primary	Postpartum weight retention	Difference between 1) preconception weight and 2) weight at 1 year postpartum,	1 year postpartum
Secondary	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
Secondary	Postpartum diabetes screening result	Result of postpartum OGTT.	4-12 weeks postpartum
Secondary	Abdominal circumference	Abdominal circumference at any time point in the first year after giving birth.	4-12 weeks and 1 year postpartum
Secondary	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
Secondary	Postpartum visit attendance	Attendance at a comprehensive postpartum care visit by 12 weeks postpartum.	4-12 weeks postpartum
Secondary	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
Secondary	Postpartum transition to primary care	Number of women with appointment made and kept for primary care by 1 year postpartum.	1 year postpartum
Secondary	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
Secondary	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
Secondary	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