Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

May 9, 2023 updated by: Amy A. Sarma, MD, Massachusetts General Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Behavioral: virtual cardiac wellness program
Participants assigned to this arm will participate in the experimental intervention.
Placebo Comparator: Placebo comparator
Behavioral: Placebo comparator
Participants assigned to this arm will participate in a placebo intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postpartum weight loss at 6 months postpartum
Time Frame: 1 year
Postpartum weight loss (Last prenatal visit weight- weight at 6 months postpartum) as a proportion of weight gained during pregnancy (Last prenatal visit weight- either 1st prenatal weight or pre-pregnancy weight within 1 year)
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postpartum weight loss at 1 year postpartum
Time Frame: 1 year
Postpartum weight loss (from last prenatal visit weight) at 1 year postpartum as a proportion of weight gained during pregnancy
1 year
Return to pre-pregnancy weight
Time Frame: 6 months
Proportion of women who return to pre-pregnancy weight at 6 months postpartum
6 months
Return to pre-pregnancy weight
Time Frame: 1 year
Proportion of women who return to pre-pregnancy weight at 1 year postpartum
1 year
Changes in blood pressure
Time Frame: 6 months
Systolic and diastolic blood pressure at 6 months postpartum
6 months
Changes in blood pressure
Time Frame: 1 year
Systolic and diastolic blood pressure at 1 year postpartum
1 year
Change in sedentary time
Time Frame: 6 months
Change in self-reported sedentary time from study enrollment and study completion (completion of the study intervention). Decreased sedentary time means better outcomes.
6 months
Change in physical activity as assessed by self-reported physical activity survey
Time Frame: 6 months
Change in self-reported physical activity from study enrollment and study completion as assessed by self-reported physical activity survey (Days per week exercised, length of exercise sessions). Increased physical activity means a better outcome.
6 months
Change in physical activity as assessed by modified Duke Activity Status Index
Time Frame: 6 months
Change in self-reported physical activity from study enrollment and study completion as assessed by modified Duke Activity Status Index (6 question yes/no survey, score ranges from 0-31.5). A higher score means a higher functional status.
6 months
Change in stress as assessed by self-reported stress survey
Time Frame: 6 months
Change in self-reported stress from study enrollment and study completion as assessed by self-reported stress survey (3 questions on scale of 0-4 [0= Never experience stress, 4= Constant stress], Max score=12). A lower score means a better outcome.
6 months
Change in stress as assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire
Time Frame: 6 months
Change in self-reported stress from study enrollment and study completion as assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire (11 questions on scale of 0-4 [0= None of the Time, 4= All of the Time], Max score=44). A lower score means a better outcome.
6 months
Change in self efficacy for diet
Time Frame: 6 months
Change in self efficacy to eat a healthy diet from study enrollment and study completion assessed by an 8-question survey rating confidence for motivating oneself to do tasks relating to eating healthy consistently for at least 6 months (Range 1 [I could not do it] to 5 [I could do it], Max score= 40). A higher score means a better outcome.
6 months
Change in self efficacy for physical activity assessed by questionnaire
Time Frame: 6 months
Change in self efficacy toward achieving and maintaining a healthy level of physical activity assessed by an 8-question survey rating confidence for motivating oneself to do tasks related to physical activity consistently for at least 6 months (Range 1 [I could not do it] to 5 [I could do it], Max score= 40). A higher score means a better outcome.
6 months
Change in cardiovascular disease knowledge assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire
Time Frame: 6 months
Change in knowledge on the American Heart Association Cardiovascular Disease Go Red Questionnaire (modified for the postpartum population) from study enrollment and study completion (5 questions total: 4 questions on scale of 0-4 [0= Very well informed, 4= Not at all informed], Max score=16, 16-part question about the causes of heart disease [1= Yes, 2 =No], Max score = 32). A lower score means a better outcome.
6 months
Change in quality of diet assessed by Dietary Approaches to Stop Hypertension (DASH) score
Time Frame: 6 months
Change in quality of diet assessed by Dietary Approaches to Stop Hypertension (DASH) score from study enrollment and study completion (DASH score range 0 [no targets met] to 9 [all targets met]). A higher score means a better outcome.
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent of scheduled postpartum obstetric visits attended in each treatment group
Time Frame: 1 year
Percent of scheduled postpartum obstetric visits attended by patients in each treatment group
1 year
Percent of patients who attend a primary care doctor visit in each treatment group
Time Frame: 1 year
Percent of patients who attend a primary care doctor visit in the 1st postpartum year in each treatment group
1 year
Percent of patients lactating in each treatment group at 6 months postpartum
Time Frame: 6 months
Percent of patients lactating in each treatment group at 6 months postpartum
6 months
Percent of patients lactating in each treatment group at 1 year postpartum
Time Frame: 1 year
Percent of patients lactating in each treatment group at 1 year postpartum
1 year
Percent of patients taking prescribed medications in each treatment group
Time Frame: 6 months
Percent of patients who were taking prescribed medications (as assessed by refill requests documented in Epic) in each treatment group
6 months
Percent of study visits completed by patients in the intervention arm
Time Frame: 6 months
Percent of study visits (out of the nutrition consultations and EP virtual visits) completed by patients in the intervention arm
6 months
Acceptability of the intervention
Time Frame: 6 months
Acceptability of the intervention among study participants as assessed by exit survey (7 questions, 0= Strongly disagree, 4= Strongly agree, Max score= 28). A higher score means a better outcome.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy A Sarma, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021P001285

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings