Clinical trial NCT04998942: Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy
Official title: Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension in Pregnancy
Gestational Hypertension
Preeclampsia
Chronic Hypertension With Pre-Eclampsia
Eclampsia
Chronic Hypertension in Obstetric Context
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postpartum weight loss at 6 months postpartum
timeFrame: 1 year
Secondary outcomes:
measure: Postpartum weight loss at 1 year postpartum
timeFrame: 1 year
measure: Return to pre-pregnancy weight
timeFrame: 6 months
measure: Return to pre-pregnancy weight
timeFrame: 1 year
measure: Changes in blood pressure
timeFrame: 6 months
measure: Changes in blood pressure
timeFrame: 1 year
measure: Change in sedentary time
timeFrame: 6 months
measure: Change in physical activity as assessed by self-reported physical activity survey
timeFrame: 6 months
measure: Change in physical activity as assessed by modified Duke Activity Status Index
timeFrame: 6 months
measure: Change in stress as assessed by self-reported stress survey
timeFrame: 6 months
measure: Change in stress as assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire
timeFrame: 6 months
measure: Change in self efficacy for diet
timeFrame: 6 months
measure: Change in self efficacy for physical activity assessed by questionnaire
timeFrame: 6 months
measure: Change in cardiovascular disease knowledge assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire
timeFrame: 6 months
measure: Change in quality of diet assessed by Dietary Approaches to Stop Hypertension (DASH) score
timeFrame: 6 months
Other outcomes:
measure: Percent of scheduled postpartum obstetric visits attended in each treatment group
timeFrame: 1 year
measure: Percent of patients who attend a primary care doctor visit in each treatment group
timeFrame: 1 year
measure: Percent of patients lactating in each treatment group at 6 months postpartum
timeFrame: 6 months
measure: Percent of patients lactating in each treatment group at 1 year postpartum
timeFrame: 1 year
measure: Percent of patients taking prescribed medications in each treatment group
timeFrame: 6 months
measure: Percent of study visits completed by patients in the intervention arm
timeFrame: 6 months
measure: Acceptability of the intervention
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Amy A Sarma, MD
role: PRINCIPAL_INVESTIGATOR
References: