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Lifestyle Intervention for Preeclampsia (SAIL Trial)

N/A

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

not able to communicate in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post intervention measured at the completion of the last study visit, 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a lifestyle intervention to reduce the risk of preeclampsia, which is a disease of pregnancy that can lead to organ damage and death. The intervention incorporates social risk factors that may explain the racial and ethnic disparities in the disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since SAIL is a lifestyle intervention rather than a drug treatment, it may not have typical medical side effects; however, participants might experience stress or discomfort due to changes in their daily habits or discussions about personal health issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot communicate in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post intervention measured at the completion of the last study visit, 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post intervention measured at the completion of the last study visit, 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and post intervention measured at the completion of the last study visit, 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Retention

Systolic and diastolic blood pressure: 6 Weeks Postpartum

Systolic and diastolic blood pressure: Post Intervention

Secondary study objectives

Preeclampsia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 1Eligibility criteria met