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

NCT04958057 | Completed

• 2 other identifiers: PRO00041206847482
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Preeclampsia

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

Study Arms (2)

Routine prenatal care

NO INTERVENTION

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.

SAIL intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: SociAl rIsks-focused Lifestyle intervention

SAIL intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• not able to communicate in English
• major fetal anomaly
• psychiatric illness that precludes group participation

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• American Heart Association: collaborator

Study Sites (1)

Medical College of Wisconsin

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Group prenatal care with a focus on preeclampsia prevention

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 12, 2021
• Study Start: March 28, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)