Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia (SAIL)
Preeclampsia is a disease of pregnancy and first few weeks after birth. It is diagnosed as new onset of high blood pressure and injury to organs such as kidneys, liver, and brain. Preeclampsia is growing at a rapid rate - rate that exceeds diabetes and heart disease. Over half a million lives lost each year to preeclampsia. Women with a history of preeclampsia have 3-4 times the risk of high blood pressure. They also have double the risk for heart disease and stroke. Racial and ethnic disparities are present in preeclampsia. Black women are at higher risk of developing preeclampsia. They are also at much higher risk of dying from preeclampsia than other women. The reasons behind such disparities are unclear. What may explain these differences are social determinants of health. The contribution of social determinants to differences in preeclampsia is well recognized. However, a major gap in research remains strategies that address these factors. Our study will test a lifestyle intervention incorporating social risk factors to reduce the risk of preeclampsia.
Conditions:
🦠 Preeclampsia
🗓️ Study Start (Actual) 28 March 2022
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 30 September 2024
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Wauwatosa, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * self-report as African-American/Non-Hispanic black
    • * residence in inner-city Milwaukee
    • * nulliparity
    • * gestational age at enrollment \<=16 weeks
    • * able and willing to give informed consent

    Exclusion Criteria:

    • * not able to communicate in English
    • * major fetal anomaly
    • * psychiatric illness that precludes group participation
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 June 2021
  • First Submitted that Met QC Criteria 9 July 2021
  • First Posted 12 July 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 August 2023
  • Last Update Posted 14 August 2023
  • Last Verified August 2023