Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

NCT04998942 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-05-10

No results posted yet for this study

Summary

Hypertensive disorders of pregnancy (HDP) are now well-recognized risk factors for adverse outcomes in the postpartum period and for development of future cardiovascular disease (CVD). Postpartum BMI has emerged as a strong predictor of both short- and long-term blood pressure (BP) control in observational studies suggesting that earlier postpartum lifestyle modifications may be instrumental in future CVD risk reduction in women with HDP. While such lifestyle modifications are recognized as critical for postpartum health, implementation and engagement of postpartum women remains a challenge as new mothers face greater barriers to in-person care given childcare responsibilities. The proposed study will investigate the acceptability of a virtual cardiac wellness program and its impact on weight, lifestyle modifications, cardiometabolic health, patient engagement, and outcomes following HDP as compared to the standard of care for postpartum women at Massachusetts General Hospital.

Conditions

  • Hypertension in Pregnancy
  • Gestational Hypertension
  • Preeclampsia
  • Chronic Hypertension With Pre-Eclampsia
  • Eclampsia
  • Chronic Hypertension in Obstetric Context

Interventions

BEHAVIORAL

virtual cardiac wellness program

Participants assigned to this arm will participate in the experimental intervention.

BEHAVIORAL

Placebo comparator

Participants assigned to this arm will participate in a placebo intervention.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Amy A Sarma, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2023-03-13
Completion
2023-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998942 on ClinicalTrials.gov