Clinical trial NCT03749746: Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Gestational Hypertension
Hypertension
Obesity
Overweight and Obesity
Pregnancy Complications
Pregnancy Toxemia
Postpartum Preeclampsia
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: 4-8 weeks postpartum to 8-12 months postpartum
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 8-12 months postpartum
measure: Diastolic blood pressure
timeFrame: 8-12 months postpartum
measure: Hypertension
timeFrame: 8-12 months postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: Magee-Womens Hospital of University of Pittsburgh Medical Center
name: Alisse Hauspurg, MD
role: PRINCIPAL_INVESTIGATOR
References: