Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia (SAIL) (SAIL)

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

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Behavioral: SAIL

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine prenatal care; Routine prenatal care: All women participating in the study will receive routine prenatal care by their obstetric provider, consisting of 1 prenatal visit a month up to 28 weeks of gestation, 1 prenatal visit every 2 weeks during 28-36 weeks and weekly visits during 36-40 weeks.
Experimental: SAIL intervention; 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.	Behavioral: SAIL; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	Retention will be measured by session attendance rates.	Post intervention measured at the completion of the last study visit, 3 years
Systolic and diastolic blood pressure: Post Intervention	BP will be taken by a study trained and certified research assistant using the study OMRON automated device.	Post intervention/at the last study visit, up to 40 weeks
Systolic and diastolic blood pressure: 6 Weeks Postpartum	BP will be taken by a study trained and certified research assistant using the study OMRON automated device.	At 6 weeks postpartum visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preeclampsia	The rate of preeclampsia diagnosis will be compared between intervention and control group.	At the 6 weeks postpartum visit through patient interview, confirmed with medical record review

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: American Heart Association

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 3, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: PRO00041206; 847482 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The proposed study will be conducted, and the data analyzed, and results disseminated in an objective and transparent manner. All investigators are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No