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

NCT03749746 | Completed DMC

• 1 other identifier: 18080007
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Weight loss

  weight change between two study visits

  4-8 weeks postpartum to 8-12 months postpartum

Secondary Outcomes (3)

• Systolic blood pressure

  8-12 months postpartum

• Diastolic blood pressure

  8-12 months postpartum

• Hypertension

  8-12 months postpartum

Study Arms (3)

Usual care

ACTIVE COMPARATOR

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.

Other: Usual care

Home Blood Pressure Monitoring

EXPERIMENTAL

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.

Behavioral: Home Blood Pressure Monitoring

Heart Health 4 New Moms

EXPERIMENTAL

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.

Behavioral: Home Blood Pressure Monitoring; Behavioral: Heart Health 4 New Moms

Interventions

Home Blood Pressure Monitoring BEHAVIORAL

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.

Heart Health 4 New Moms; Home Blood Pressure Monitoring

Heart Health 4 New Moms BEHAVIORAL

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).

Heart Health 4 New Moms

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pre-pregnancy body mass index ≥25 kg/m2
• diagnosed with preeclampsia or gestational hypertension
• access to internet

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Hauspurg A, Bryan S, Jeyabalan A, Davis EM, Hart R, Shirriel J, Muldoon MF, Catov JM. Blood Pressure Trajectories Through the First Year Postpartum in Overweight or Obese Individuals Following a Hypertensive Disorder of Pregnancy. Hypertension. 2024 Feb;81(2):302-310. doi: 10.1161/HYPERTENSIONAHA.123.22231. Epub 2023 Dec 11.

  PMID: 38073563 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension; Obesity; Overweight; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alisse Hauspurg, MD

  Magee-Womens Hospital of University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 21, 2018
• Study Start: January 26, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)