Lifestyle Intervention for Preeclampsia

(SAIL Trial)

Overseen By Eleanor Saffian, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Non-English, Major fetal anomaly, Psychiatric illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

100 Participants Needed

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a social risks-focused lifestyle intervention with 6 monthly group sessions during the second and third trimesters

6 months

6 group sessions (in-person)

Routine Prenatal Care

Participants receive routine prenatal care with varying visit frequency based on gestational age

Up to 40 weeks

1 visit/month up to 28 weeks, 1 visit/2 weeks during 28-36 weeks, weekly visits during 36-40 weeks

Follow-up

Participants are monitored for preeclampsia and blood pressure at 6 weeks postpartum

6 weeks postpartum

1 visit (in-person)

Treatment Details

Interventions

• SAIL

Trial Overview 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.

Participant Groups

Group I: SAIL intervention Experimental Treatment 1 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 care Active Control 1 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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+