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Behavioural Intervention

Mobile Health Interventions for Heart Disease Prevention After High Blood Pressure in Pregnancy (mHEART Trial)

N/A

Recruiting

Led By Priya M Freaney, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months postpartum; 12 months postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate how digital health tools can help prevent heart disease in people who have had high blood pressure during pregnancy.

Who is the study for?

This trial is for individuals who gave birth at Northwestern Memorial Hospital with a live baby at any gestational age and had new-onset hypertensive disorders during pregnancy, like pre-eclampsia or eclampsia. It's not specified who can't join the trial.

What is being tested?

The study is testing digital health tools to prevent heart disease in those who've experienced high blood pressure disorders during pregnancy. Participants will use a remote patient monitoring system and a mobile health application.

What are the potential side effects?

Since this trial involves non-invasive digital interventions, typical side effects are minimal but may include discomfort from wearing monitoring devices or stress/anxiety related to constant health tracking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant and have been diagnosed with a high blood pressure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months postpartum; 12 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months postpartum; 12 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months postpartum; 12 months postpartum for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Systolic blood pressure

Secondary study objectives

Anti-hypertensive medication use (%)

Participant engagement

Study feasibility

+2 more

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: Bundled digital health interventionExperimental Treatment2 Interventions

Participant will be enrolled in a remote patient monitoring program (Omron) and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care.

Group II: Usual Care (Control)Active Control1 Intervention

Participant will receive usual care.

0 / 1Eligibility criteria met