Chronic Hypertension in Obstetric Context, Chronic Hypertension With Pre-Eclampsia, Eclampsia, Gestational Hypertension, Hypertension in Pregnancy, Preeclampsia
Conditions
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.
Interventions
BEHAVIORALvirtual cardiac wellness program
Participants assigned to this arm will participate in the experimental intervention.
BEHAVIORALPlacebo comparator
Participants assigned to this arm will participate in a placebo intervention.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
| 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. |
| 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 | 6 months | Proportion of women who return to pre-pregnancy weight at 6 months postpartum |
| Changes in blood pressure | 6 months | Systolic and diastolic blood pressure at 6 months postpartum |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients who attend a primary care doctor visit in each treatment group | 1 year | Percent of patients who attend a primary care doctor visit in the 1st postpartum year in each treatment group |
| Percent of patients lactating in each treatment group at 6 months postpartum | 6 months | Percent of patients lactating in each treatment group at 6 months postpartum |
| Percent of patients taking prescribed medications in each treatment group | 6 months | Percent of patients who were taking prescribed medications (as assessed by refill requests documented in Epic) in each treatment group |
| Percent of study visits completed by patients in the intervention arm | 6 months | Percent of study visits (out of the nutrition consultations and EP virtual visits) completed by patients in the intervention arm |
| Acceptability of the intervention | 6 months | 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. |
| Percent of scheduled postpartum obstetric visits attended in each treatment group | 1 year | Percent of scheduled postpartum obstetric visits attended by patients in each treatment group |
| Percent of patients lactating in each treatment group at 1 year postpartum | 1 year | Percent of patients lactating in each treatment group at 1 year postpartum |
Countries
United States
Outcome results
None listed