Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Obesity Weight Loss, Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | January 26, 2019 |
| End Date: | December 2021 |
| Contact: | Nidha Khan, MPH |
| Email: | khann4@mwri.magee.edu |
| Phone: | 412-641-3295 |
Heart Health 4 New Moms: A Randomized Controlled Trial of a Lifestyle Intervention and Home Blood Pressure Monitoring Following Preeclampsia in Overweight and Obese Women
Preeclampsia causes devastating maternal and neonatal morbidity and mortality with a high
recurrence risk and a rapid, occult progression to cardiovascular disease after delivery.
There is a critical need for effective interventions to reduce these risks. This is a pilot
randomized controlled trial of a novel postpartum lifestyle intervention compared to women
who take home blood pressure measurements and women with usual care who are overweight and
obese in the first year after preeclampsia. The investigators hypothesize that the
intervention will lead to improved weight loss and blood pressure in the first year
postpartum, which has broad implications for future pregnancy and long-term cardiovascular
health.
recurrence risk and a rapid, occult progression to cardiovascular disease after delivery.
There is a critical need for effective interventions to reduce these risks. This is a pilot
randomized controlled trial of a novel postpartum lifestyle intervention compared to women
who take home blood pressure measurements and women with usual care who are overweight and
obese in the first year after preeclampsia. The investigators hypothesize that the
intervention will lead to improved weight loss and blood pressure in the first year
postpartum, which has broad implications for future pregnancy and long-term cardiovascular
health.
The overall objective of this study is to conduct a pilot trial of an internet-based
lifestyle intervention and home blood pressure monitoring in the year after delivery among
overweight and obese women with preeclampsia to evaluate feasibility, acceptability and to
assess the effect of the intervention. The investigators hypothesize that compared to usual
care, an internet-based lifestyle intervention implemented in the immediate postpartum period
in overweight and obese women with preeclampsia improves weight loss at one year postpartum.
90 overweight or obese women with preeclampsia will be randomized into internet-based
lifestyle intervention plus home blood pressure monitoring, home blood pressure monitoring
alone, or usual care groups in the postpartum period. The investigators will assess
feasibility by the proportions of women who are eligible, enroll, and remain in the study at
one year. The effect of home blood pressure monitoring on blood pressure and progression to
sustained hypertension will also be explored. A successful outcome of this study would have a
direct impact to improve cardiovascular health and future pregnancy health in women who have
had preeclampsia.
lifestyle intervention and home blood pressure monitoring in the year after delivery among
overweight and obese women with preeclampsia to evaluate feasibility, acceptability and to
assess the effect of the intervention. The investigators hypothesize that compared to usual
care, an internet-based lifestyle intervention implemented in the immediate postpartum period
in overweight and obese women with preeclampsia improves weight loss at one year postpartum.
90 overweight or obese women with preeclampsia will be randomized into internet-based
lifestyle intervention plus home blood pressure monitoring, home blood pressure monitoring
alone, or usual care groups in the postpartum period. The investigators will assess
feasibility by the proportions of women who are eligible, enroll, and remain in the study at
one year. The effect of home blood pressure monitoring on blood pressure and progression to
sustained hypertension will also be explored. A successful outcome of this study would have a
direct impact to improve cardiovascular health and future pregnancy health in women who have
had preeclampsia.
Inclusion Criteria:
- pre-pregnancy body mass index ≥25 kg/m2
- diagnosed with preeclampsia
- access to internet
Exclusion Criteria:
- multiple gestation
- medical co-morbidities: chronic kidney disease, active liver disease (acute hepatitis,
chronic active hepatitis), active cardiac disease, pre-pregnancy diabetes mellitus,
chronic hypertension diagnosed prior to pregnancy
- pregnancy prior to randomization
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Alisse Hauspurg, MD
Phone: 412-641-3295
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