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

NCT ID: NCT03749746

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-26

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Home Blood Pressure Monitoring

Intervention Type 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

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.

Group Type EXPERIMENTAL

Home Blood Pressure Monitoring

Intervention Type 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

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Alisse Hauspurg

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alisse Hauspurg, MD

Role: PRINCIPAL_INVESTIGATOR

Magee-Womens Hospital of University of Pittsburgh Medical Center

Locations

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University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38073563 (View on PubMed)

Other Identifiers

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18080007

Identifier Type: -

Identifier Source: org_study_id