Clinical trial NCT04958057: Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia (SAIL)
Official title: Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia in AA Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preeclampsia
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2021-07-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group prenatal care with a focus on preeclampsia prevention
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Retention
timeFrame: Post intervention measured at the completion of the last study visit, 3 years
measure: Systolic and diastolic blood pressure: Post Intervention
timeFrame: Post intervention/at the last study visit, up to 40 weeks
measure: Systolic and diastolic blood pressure: 6 Weeks Postpartum
timeFrame: At 6 weeks postpartum visit
Secondary outcomes:
measure: Preeclampsia
timeFrame: At the 6 weeks postpartum visit through patient interview, confirmed with medical record review
Other outcomes:
Locations:
city: Wauwatosa
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: