Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

NCT04998942 | Unknown

• 1 other identifier: 2021P001285
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Postpartum weight loss at 1 year postpartum

  1 year

• Return to pre-pregnancy weight

  6 months

• Return to pre-pregnancy weight

  1 year

• Changes in blood pressure

  6 months

• Changes in blood pressure

  1 year

Other Outcomes (7)

• Percent of scheduled postpartum obstetric visits attended in each treatment group

  1 year

• Percent of patients who attend a primary care doctor visit in each treatment group

  1 year

• Percent of patients lactating in each treatment group at 6 months postpartum

  6 months

Study Arms (2)

Experimental

EXPERIMENTAL

Behavioral: virtual cardiac wellness program

Placebo comparator

PLACEBO COMPARATOR

Behavioral: Placebo comparator

Interventions

virtual cardiac wellness program BEHAVIORAL

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

Experimental

Placebo comparator BEHAVIORAL

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

Placebo comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Amy A Sarma, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 10, 2021
• Study Start: August 11, 2021
• Primary Completion: March 13, 2023
• Study Completion: June 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)