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临床试验/NCT04583839
NCT04583839已完成不适用

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

Northwestern University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Postpartum weight retention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Postpartum weight retention

时间窗: 1 year postpartum

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

次要结局

  • Postpartum diabetes screening result(4-12 weeks postpartum)
  • Postpartum diabetes screening completion(4-12 weeks postpartum)
  • Abdominal circumference(4-12 weeks and 1 year postpartum)
  • Postpartum visit attendance(4-12 weeks postpartum)
  • Diabetes self-efficacy(4-12 weeks and 1 year postpartum)
  • Patient activation(4-12 weeks and 1 year postpartum)
  • Blood pressure(4-12 weeks and 1 year postpartum)
  • Assessment of postpartum glycemic control(1 year postpartum)
  • Postpartum transition to primary care(1 year postpartum)
  • Diabetes risk perception(4-12 weeks and 1 year postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lynn M Yee

Assistant Professor, Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology, Northwestern University

Northwestern University

研究点 (2)

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