Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy
- Conditions
- Hypertension in PregnancyPreeclampsiaChronic Hypertension With Pre-EclampsiaEclampsiaChronic Hypertension in Obstetric ContextGestational Hypertension
- Interventions
- Behavioral: virtual cardiac wellness programBehavioral: Placebo comparator
- Registration Number
- NCT04998942
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental virtual cardiac wellness program - Placebo comparator Placebo comparator -
- Primary Outcome Measures
Name Time Method Postpartum weight loss at 6 months postpartum 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)
- Secondary Outcome Measures
Name Time Method Change in stress as assessed by self-reported stress survey 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.
Change in self efficacy for physical activity assessed by questionnaire 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.
Change in cardiovascular disease knowledge assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire 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.
Postpartum weight loss at 1 year postpartum 1 year 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 1 year Proportion of women who return to pre-pregnancy weight at 1 year postpartum
Changes in blood pressure 1 year Systolic and diastolic blood pressure at 1 year postpartum
Change in self efficacy for diet 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.
Change in sedentary time 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.
Change in physical activity as assessed by modified Duke Activity Status Index 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.
Change in quality of diet assessed by Dietary Approaches to Stop Hypertension (DASH) score 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.
Change in physical activity as assessed by self-reported physical activity survey 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.
Change in stress as assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire 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.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States