Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this study, we are testing different strategies to help women keep their heart healthy after a pregnancy complicated by hypertension.

Participants may or may not undergo some of the following study procedures:

* Complete surveys which could include topics related to activity, stress, nutrition, heart disease etc. with study staff via telephone or a secure online platform
* Be contacted by study staff once monthly to collect subjects' weight, blood pressure, whether they are breastfeeding, exercise routine, smoking status, and stress levels
* Meet with a nutritionist
* Meet with an exercise physiologist
* Participate in optional group sessions
* Receive infographics which could include topics such as mindful living and lifestyle, prevention of heart disease, nutrition, heart disease, etc.

Arm assignment and a description of the arms will be disclosed to participants after study completion.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

In order to enable us to conduct a placebo-controlled study, we will not disclose to participants which intervention they have been assigned to. In order to obtain blinded data, incomplete disclosure is necessary to make the research scientifically valid and feasible. Unblinding subjects increases the risk that a favorable outcome is associated with the intervention simply because subjects are aware that they received an intervention and thus performing a placebo-controlled trial is necessary to determine the true effect of the intervention.

Study Groups

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Experimental

Group Type EXPERIMENTAL

virtual cardiac wellness program

Intervention Type BEHAVIORAL

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

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type BEHAVIORAL

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

Interventions

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virtual cardiac wellness program

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

Intervention Type BEHAVIORAL

Placebo comparator

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No