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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 148
- Locations
- 2
- Primary Endpoint
- Weight loss
Study Overview
Brief Summary
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.
Detailed Description
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. 150 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •pre-pregnancy body mass index ≥25 kg/m2
- •diagnosed with preeclampsia or gestational hypertension
- •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
Outcomes
Primary Outcomes
Weight loss
Time Frame: 4-8 weeks postpartum to 8-12 months postpartum
weight change between two study visits
Secondary Outcomes
- Hypertension(8-12 months postpartum)
- Systolic blood pressure(8-12 months postpartum)
- Diastolic blood pressure(8-12 months postpartum)
Investigators
Alisse Hauspurg
Assistant Professor
University of Pittsburgh