Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

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: Active, not recruiting
• Conditions: Eclampsia; Preeclampsia; Hypertension in Pregnancy; Gestational Hypertension; Chronic Hypertension With Pre-Eclampsia; Chronic Hypertension in Obstetric Context
• Intervention / Treatment: Behavioral: virtual cardiac wellness program; Behavioral: Placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilona T Goldfarb, MD; Phone Number: 617-724-2640; Email: igoldfarb@partners.org
• Study Contact Backup: Name: Amy A Sarma, MD; Phone Number: 978-882-6191; Email: asarma1@partners.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Postpartum weight loss at 6 months postpartum	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

Outcome Measure	Measure Description	Time Frame
Postpartum weight loss at 1 year postpartum	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	Proportion of women who return to pre-pregnancy weight at 6 months postpartum	6 months
Return to pre-pregnancy weight	Proportion of women who return to pre-pregnancy weight at 1 year postpartum	1 year
Changes in blood pressure	Systolic and diastolic blood pressure at 6 months postpartum	6 months
Changes in blood pressure	Systolic and diastolic blood pressure at 1 year postpartum	1 year
Change in sedentary time	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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Percent of scheduled postpartum obstetric visits attended in each treatment group	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	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	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	Percent of patients lactating in each treatment group at 1 year postpartum	1 year
Percent of patients taking prescribed medications in each treatment group	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	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	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

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Amy A Sarma, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): March 13, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Pregnancy Complications; Toxemia; Hypertension; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Other Study ID 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