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

Status: Completed
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
United States
Wisconsin
Medical College of Wisconsin
Wauwatosa
Time Frame
Start Date: 2022-03-28
Completion Date: 2024-12-31
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin
Collaborators: American Heart Association

This content was sourced from clinicaltrials.gov