Lifestyle Intervention for Preeclampsia
(SAIL Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical College of Wisconsin

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for African-American/Non-Hispanic black women who are pregnant for the first time, less than 16 weeks along, living in inner-city Milwaukee, and can give informed consent. It's not open to those who don't speak English or have psychiatric illnesses that would prevent them from participating in group activities.

Inclusion Criteria

gestational age at enrollment <=16 weeks

You have never been pregnant.

able and willing to give informed consent

+2 more

Exclusion Criteria

You have a mental illness that makes it difficult for you to participate in group activities.

The unborn baby has a severe abnormality.

I cannot communicate in English.

Participant Groups

The SAIL program is being tested as a lifestyle intervention aimed at reducing the risk of preeclampsia by incorporating social risk factors into its strategy. The study focuses on addressing health disparities that contribute to higher risks of this condition among black women.

2Treatment groups

Experimental Treatment

Active Control

Group I: SAIL interventionExperimental Treatment1 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 II: Routine prenatal careActive Control1 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.