Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy
Primary Purpose
Hypertension in Pregnancy, Gestational Hypertension, Preeclampsia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
virtual cardiac wellness program
Placebo comparator
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension in Pregnancy
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo comparator
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Return to pre-pregnancy weight
Proportion of women who return to pre-pregnancy weight at 6 months postpartum
Return to pre-pregnancy weight
Proportion of women who return to pre-pregnancy weight at 1 year postpartum
Changes in blood pressure
Systolic and diastolic blood pressure at 6 months postpartum
Changes in blood pressure
Systolic and diastolic blood pressure at 1 year postpartum
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04998942
First Posted
July 12, 2021
Last Updated
May 9, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04998942
Brief Title
Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy
Official Title
Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia, Eclampsia, Chronic Hypertension in Obstetric Context
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
virtual cardiac wellness program
Intervention Description
Participants assigned to this arm will participate in the experimental intervention.
Intervention Type
Behavioral
Intervention Name(s)
Placebo comparator
Intervention Description
Participants assigned to this arm will participate in a placebo intervention.
Primary Outcome Measure Information:
Title
Postpartum weight loss at 6 months postpartum
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Postpartum weight loss at 1 year postpartum
Description
Postpartum weight loss (from last prenatal visit weight) at 1 year postpartum as a proportion of weight gained during pregnancy
Time Frame
1 year
Title
Return to pre-pregnancy weight
Description
Proportion of women who return to pre-pregnancy weight at 6 months postpartum
Time Frame
6 months
Title
Return to pre-pregnancy weight
Description
Proportion of women who return to pre-pregnancy weight at 1 year postpartum
Time Frame
1 year
Title
Changes in blood pressure
Description
Systolic and diastolic blood pressure at 6 months postpartum
Time Frame
6 months
Title
Changes in blood pressure
Description
Systolic and diastolic blood pressure at 1 year postpartum
Time Frame
1 year
Title
Change in sedentary time
Description
Change in self-reported sedentary time from study enrollment and study completion (completion of the study intervention). Decreased sedentary time means better outcomes.
Time Frame
6 months
Title
Change in physical activity as assessed by self-reported physical activity survey
Description
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.
Time Frame
6 months
Title
Change in physical activity as assessed by modified Duke Activity Status Index
Description
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.
Time Frame
6 months
Title
Change in stress as assessed by self-reported stress survey
Description
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.
Time Frame
6 months
Title
Change in stress as assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire
Description
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.
Time Frame
6 months
Title
Change in self efficacy for diet
Description
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.
Time Frame
6 months
Title
Change in self efficacy for physical activity assessed by questionnaire
Description
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.
Time Frame
6 months
Title
Change in cardiovascular disease knowledge assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire
Description
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.
Time Frame
6 months
Title
Change in quality of diet assessed by Dietary Approaches to Stop Hypertension (DASH) score
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Percent of scheduled postpartum obstetric visits attended in each treatment group
Description
Percent of scheduled postpartum obstetric visits attended by patients in each treatment group
Time Frame
1 year
Title
Percent of patients who attend a primary care doctor visit in each treatment group
Description
Percent of patients who attend a primary care doctor visit in the 1st postpartum year in each treatment group
Time Frame
1 year
Title
Percent of patients lactating in each treatment group at 6 months postpartum
Description
Percent of patients lactating in each treatment group at 6 months postpartum
Time Frame
6 months
Title
Percent of patients lactating in each treatment group at 1 year postpartum
Description
Percent of patients lactating in each treatment group at 1 year postpartum
Time Frame
1 year
Title
Percent of patients taking prescribed medications in each treatment group
Description
Percent of patients who were taking prescribed medications (as assessed by refill requests documented in Epic) in each treatment group
Time Frame
6 months
Title
Percent of study visits completed by patients in the intervention arm
Description
Percent of study visits (out of the nutrition consultations and EP virtual visits) completed by patients in the intervention arm
Time Frame
6 months
Title
Acceptability of the intervention
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy A Sarma, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy
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