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Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia (HH4NM)

Primary Purpose

Preeclampsia, Gestational Hypertension, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Blood Pressure Monitoring
Heart Health 4 New Moms
Usual care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh Magee-Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual care

Home Blood Pressure Monitoring

Heart Health 4 New Moms

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Weight loss
weight change between two study visits

Secondary Outcome Measures

Systolic blood pressure
Systolic blood pressure at study visit 2
Diastolic blood pressure
Diastolic blood pressure at study visit 2
Hypertension
Proportion of women with hypertension by AHA guidelines

Full Information

First Posted
November 20, 2018
Last Updated
December 2, 2021
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03749746
Brief Title
Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia
Acronym
HH4NM
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Gestational Hypertension, Hypertension, Obesity, Overweight and Obesity, Pregnancy Complications, Pregnancy Toxemia, Postpartum Preeclampsia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Home Blood Pressure Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Heart Health 4 New Moms
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home Blood Pressure Monitoring
Intervention Description
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
Intervention Name(s)
Heart Health 4 New Moms
Intervention Description
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
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Description
weight change between two study visits
Time Frame
4-8 weeks postpartum to 8-12 months postpartum
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure at study visit 2
Time Frame
8-12 months postpartum
Title
Diastolic blood pressure
Description
Diastolic blood pressure at study visit 2
Time Frame
8-12 months postpartum
Title
Hypertension
Description
Proportion of women with hypertension by AHA guidelines
Time Frame
8-12 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alisse Hauspurg, MD
Organizational Affiliation
Magee-Womens Hospital of University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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