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

NCT06523569 | Recruiting

• 1 other identifier: STU00219095
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Keywords

digital health; echocardiogram; blood pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Weight

  3 months postpartum; 12 months postpartum

• Subclinical cardiovascular dysfunction via echocardiography

  3 months postpartum; 12 months postpartum

• Study feasibility

  12 months postpartum

• Participant engagement

  12 months postpartum

• Anti-hypertensive medication use (%)

  3 months postpartum; 12 months postpartum

Study Arms (2)

Usual Care (Control)

NO INTERVENTION

Participant will receive usual care.

Bundled digital health intervention

EXPERIMENTAL

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

Interventions

Digital Blood Pressure Monitoring System OTHER

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.

Bundled digital health intervention

Mobile health application OTHER

As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.

Bundled digital health intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Friends of Prentice: collaborator
• Senior Faculty Academy: collaborator

Study Sites (1)

Northwestern University, Dept. of Cardiology

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Priya M Freaney, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priya M Freaney, MD

CONTACT

(312) 664-3278; priya.freaney@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 26, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)