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

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.

Conditions

• Preeclampsia
• Gestational Hypertension
• Hypertension
• Obesity
• Overweight and Obesity
• Pregnancy Complications
• Pregnancy Toxemia
• Postpartum Preeclampsia

Interventions

BEHAVIORAL

Home Blood Pressure Monitoring

Each participant will receive 1:1 training by the project staff in all aspects of home blood pressure monitoring (HBPM). Throughout the study, they will be asked to monitor home blood pressures for the first week of each month with Bluetooth-enabled blood pressure cuffs.

BEHAVIORAL

Heart Health 4 New Moms

The intervention is comprised of four key components: (1) The online curriculum consists of 12 modules on healthy eating and physical activity adapted from the Diabetes Prevention Program and specifically targeting postpartum women. (2) Self-monitoring and tracking program, in which participants will be provided with a Bluetooth-enabled blood pressure cuff and digital scale and will be provided real-time feedback on their blood pressure and weight trends. (3) A registered dietitian will act as a lifestyle coach for participants with regular review of progress and provision of coaching notes, support and suggestions. (4) Finally participants will have access to a customized online toolbox, including dietary tracking sheets and recipes from the American Heart Association (AHA).

OTHER

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.

Sponsors & Collaborators

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Alisse Hauspurg, MD · Magee-Womens Hospital of University of Pittsburgh Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-26

Primary Completion

2021-12-01

Completion

2021-12-01

Countries

• United States

Study Locations