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

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).

Study Overview

• Status: Recruiting
• Conditions: Eclampsia; Pre-Eclampsia; Hypertension in Pregnancy; Gestational Hypertension
• Intervention / Treatment: Other: Mobile health application; Other: Digital Blood Pressure Monitoring System

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Priya M Freaney, MD; Phone Number: (312) 664-3278; Email: priya.freaney@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University, Dept. of Cardiology
      • Principal Investigator: Priya Freaney, MD
      • Contact: Kathleen Flores; Phone Number: 312-503-1069; Email: kathleen.flores@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care (Control); Participant will receive usual care.
Experimental: Bundled digital health intervention; 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.	Other: Mobile health application; As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.; Other: Digital Blood Pressure Monitoring System; As a part of the bundled digital health intervention, the participant will receive instructions on how to follow a link in their electronic patient portal that will allow direct input of home blood pressure readings for clinical review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	All participants will have systolic blood pressure measured at 3 months and 12 months postpartum	3 months postpartum; 12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	All participants will have weight measured at 3 months and 12 months postpartum	3 months postpartum; 12 months postpartum
Subclinical cardiovascular dysfunction via echocardiography	All participants will have echocardiography performed at 3 months and 12 months postpartum to assess subclinical cardiovascular dysfunction	3 months postpartum; 12 months postpartum
Study feasibility	The investigators will assess study feasibility (% enrolled in digital health intervention) at the end of the study	12 months postpartum
Participant engagement	The investigators will assess participant engagement (% continuing to actively use digital health interventions) at the end of the study	12 months postpartum
Anti-hypertensive medication use (%)	The investigators will assess participant anti-hypertensive medication use (%) at 3 months and 12 months	3 months postpartum; 12 months postpartum

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Friends of Prentice; Senior Faculty Academy
• Investigators: Principal Investigator: Priya M Freaney, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: blood pressure; digital health; echocardiogram
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Infections; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension; Heart Diseases; Toxemia
• Other Study ID Numbers: STU00219095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No