Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia

Not Applicable

Completed

• Conditions: Gestational Hypertension; Obesity; Pregnancy Complications; Preeclampsia; Hypertension; Postpartum Preeclampsia; Overweight and Obesity; Pregnancy Toxemia
• Interventions: Other: Usual care; Behavioral: Home Blood Pressure Monitoring; Behavioral: Heart Health 4 New Moms

• Registration Number: NCT03749746
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Study Start: 2019-01-26
• Status Verified: 2021-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Participants will be counseled on routine postpartum care and will receive additional information on cardiovascular risk following preeclampsia as well as information on support groups and registries as well as online resources for lifestyle modification.
Heart Health 4 New Moms	Heart Health 4 New Moms	Participants randomized to this group will receive instruction on the use of Heart Health 4 New Moms internet-based lifestyle intervention and home blood pressure monitoring. The internet-based intervention is comprised of four key components: an online curriculum with modules on healthy eating and physical activity, a self-monitoring and tracking program, a registered dietitian will act as a lifestyle coach for participants and a customized online toolbox.
Home Blood Pressure Monitoring	Home Blood Pressure Monitoring	In addition to usual care outlined above, each participant will receive a Bluetooth-enabled blood pressure cuff along with a checklist of proper technique and instructions on use. Women will be prompted to measure their BP across the first week of each month during the intervention. Based on guidelines, participants will take their blood pressure in the morning and evening, each time taking two readings separated by one minute.
Heart Health 4 New Moms	Home Blood Pressure Monitoring	Participants randomized to this group will receive instruction on the use of Heart Health 4 New Moms internet-based lifestyle intervention and home blood pressure monitoring. The internet-based intervention is comprised of four key components: an online curriculum with modules on healthy eating and physical activity, a self-monitoring and tracking program, a registered dietitian will act as a lifestyle coach for participants and a customized online toolbox.

Primary Outcome Measures

Name	Time	Method
Weight loss	4-8 weeks postpartum to 8-12 months postpartum	weight change between two study visits

Secondary Outcome Measures

Name	Time	Method
Hypertension	8-12 months postpartum	Proportion of women with hypertension by AHA guidelines
Systolic blood pressure	8-12 months postpartum	Systolic blood pressure at study visit 2
Diastolic blood pressure	8-12 months postpartum	Diastolic blood pressure at study visit 2

Trial Locations

Locations (1)

University of Pittsburgh Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States