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OpenTrials
Completed

NCT Number: NCT04583839

SWEET: Postpartum Navigation After GDM

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SWEET

Primary outcomes

  1. Postpartum weight retention

    Time frame: 1 year postpartum

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

Secondary outcomes

  1. Postpartum diabetes screening completion

    Time frame: 4-12 weeks postpartum

    Number of women with completion of a 2-hour oral glucose tolerance test by 12 weeks postpartum.

  2. Postpartum diabetes screening result

    Time frame: 4-12 weeks postpartum

    Result of postpartum OGTT.

  3. Abdominal circumference

    Time frame: 4-12 weeks and 1 year postpartum

    Abdominal circumference at any time point in the first year after giving birth.

  4. Blood pressure

    Time frame: 4-12 weeks and 1 year postpartum

    Blood pressure at any time point in the first year after giving birth and proportion with hypertension.

  5. Postpartum visit attendance

    Time frame: 4-12 weeks postpartum

    Attendance at a comprehensive postpartum care visit by 12 weeks postpartum.

  6. Assessment of postpartum glycemic control

    Time frame: 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.

  7. Postpartum transition to primary care

    Time frame: 1 year postpartum

    Number of women with appointment made and kept for primary care by 1 year postpartum.

  8. Diabetes self-efficacy

    Time frame: 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.

  9. Patient activation

    Time frame: 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.

  10. Diabetes risk perception

    Time frame: 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.

Other outcomes

  1. Participant experiences and perspectives on GDM

    Time frame: 4-12 weeks and 1 year postpartum

    Qualitative feedback on experience with the GDM diagnosis, barriers to obtaining postpartum GDM-related care, and barriers and facilitators of the primary care transition.

  2. Patient experiences with navigation

    Time frame: 4-12 weeks and 1 year postpartum

    Participants who are randomized to receive navigation will complete in-depth interviews about experiences with the program and areas for improvement.

  3. Health care providers experiences with SWEET

    Time frame: Through completion of study, an average of 2 years

    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.

  4. Patient satisfaction with logistical aspects of navigation

    Time frame: 4-12 weeks and 1 year postpartum

    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.

  5. Patient satisfaction with interpersonal relationship with navigator

    Time frame: 4-12 weeks and 1 year postpartum

    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.

  6. Proportion of eligible participants who enroll

    Time frame: Through completion of study, an average of 2 years

    Proportion of eligible participants who enroll will be defined as the proportion of women who enroll out of all approached, eligible women.

  7. Recruitment rate

    Time frame: Through completion of study, an average of 2 years

    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.

  8. Time to enrollment

    Time frame: Through completion of study, an average of 2 years

    Time to enrollment will be defined as the number of months to enroll target sample size.

  9. Dropout rate

    Time frame: Through completion of study, an average of 2 years

    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.

  10. Retention rate

    Time frame: Through completion of study, an average of 2 years

    Retention rate will be defined as the proportion of enrolled women who successfully complete all study visits during 1-year follow-up period.

  11. Participant adherence with navigation

    Time frame: Through completion of study, an average of 2 years

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: SWEET

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2020
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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