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NCT Number: NCT04958057

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Wauwatosa, Wisconsin, 53226, United States

About this study

Preeclampsia is a significant global health problem affecting over 10 million pregnancies each year. Preeclampsia disproportionately burdens ethnic minority women, especially African American women when compared to non-Hispanic white women. Once diagnosed with preeclampsia, African women are 3 times more likely to die of preeclampsia compared to their white counterparts. Evidence supports contribution of social risk factors towards racial and ethnic disparities seen with preeclampsia. However, currently, there are few trials that examine efficacy of social risks-focused lifestyle interventions on reduction of preeclampsia and its complications. This proposal is designed to address this crucial gap by testing feasibility (Aim 1), acceptability (Aim 1) and efficacy (Aim 2) of a social risks-focused lifestyle intervention to reduce preeclampsia in pregnant inner-city African American women. The intervention will be delivered via a randomized control trial design (N=100), with 6 monthly group sessions conducted in the second and third trimesters. The overall hypothesis is that the intervention will be feasible and acceptable, and that women randomized to the intervention group will have lower blood pressure and lower rates of preeclampsia compared with women receiving routine prenatal care.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

SAIL

Behavioral

6 monthly group sessions with the study nurse with a background in prenatal care and the PI that will include each group will include preeclampsia education, coaching on stress management, resource navigation, and training in problem solving.

Other names: SociAl rIsks-focused Lifestyle intervention

Primary outcomes

  1. Retention

    Time frame: Post intervention measured at the completion of the last study visit, 3 years

    Retention will be measured by session attendance rates.

  2. Systolic and diastolic blood pressure: Post Intervention

    Time frame: Post intervention/at the last study visit, up to 40 weeks

    BP will be taken by a study trained and certified research assistant using the study OMRON automated device.

  3. Systolic and diastolic blood pressure: 6 Weeks Postpartum

    Time frame: At 6 weeks postpartum visit

    BP will be taken by a study trained and certified research assistant using the study OMRON automated device.

Secondary outcomes

  1. Preeclampsia

    Time frame: At the 6 weeks postpartum visit through patient interview, confirmed with medical record review

    The rate of preeclampsia diagnosis will be compared between intervention and control group.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia in AA Women

Acronym: SAIL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2021
Registry last updated
Aug 7, 2025

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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