Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy (mHEART)

Northwestern University

Status: Enrolling

Conditions: Pre-Eclampsia; Gestational Hypertension; Eclampsia; Hypertension in Pregnancy

Treatments: Other: Digital Blood Pressure Monitoring System; Other: Mobile health application

Study type: Interventional

Funder types: Other

Identifiers

NCT06523569

STU00219095

Details and patient eligibility

About

The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).

Full description

The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)
• Live birth at any gestational age
• Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)

Exclusion criteria

• HELLP syndrome
• History of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease)
• Current Omron remote patient monitoring or Noom user
• BMI<18.5 kg/m2 at enrollment
• Inadequate gestational weight gain or gestational weight loss

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Usual Care (Control)

No Intervention group

Description:

Participant will receive usual care.

Bundled digital health intervention

Experimental group

Description:

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

Treatment:

Other: Mobile health application

Other: Digital Blood Pressure Monitoring System