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

NCT ID: NCT04958057

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

SAIL

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SociAl rIsks-focused Lifestyle intervention

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Anna Palatnik, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin

Wauwatosa, Wisconsin, United States

Countries

United States

Other Identifiers

847482

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO00041206

Identifier Type: -

Identifier Source: org_study_id