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Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

Mass General Brigham logo

Mass General Brigham

Status

Active, not recruiting

Conditions

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

Treatments

Behavioral: Placebo comparator
Behavioral: virtual cardiac wellness program

Study type

Interventional

Funder types

Other

Identifiers

NCT04998942
2021P001285

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women with a diagnosis of HDP inclusive of gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with superimposed preeclampsia
  • Pre-pregnancy BMI >18.5
  • Age ≥ 18 years
  • Access to a phone
  • Delivery at MGH and receive longitudinal obstetrics care at MGH

Exclusion criteria

  • Moderate or severe cognitive impairment
  • Current incarceration
  • Pre-pregnancy BMI ≤ 18.5
  • Women without a documented pre-natal weight or weight recorded 1 year prior to pregnancy
  • Baseline exercise of > 150 minutes/ week at the time of study enrollment
  • Not cleared for exercise by primary OB

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Experimental
Experimental group
Treatment:
Behavioral: virtual cardiac wellness program
Placebo comparator
Placebo Comparator group
Treatment:
Behavioral: Placebo comparator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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