Gestational Diabetes Clinical Trial
— SWEETOfficial title:
SWEET: Sustaining Women's Engagement and Enabling Transitions After Gestational Diabetes Mellitus
Verified date | June 2024 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 31, 2024 |
Est. primary completion date | January 31, 2024 |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Memorial Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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 |
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