PreeclampsiaHH4NMNCT03749746
Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia
A study testing Home Blood Pressure Monitoring and Heart Health 4 New Moms in people with Preeclampsia and Gestational Hypertension, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Gestational Hypertension, Hypertension
- What is being tested?
- Home Blood Pressure Monitoring and Heart Health 4 New Moms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pre-pregnancy body mass index ≥25 kg/m2
- diagnosed with preeclampsia or gestational hypertension
- access to internet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
Read the 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.
- Conditions
- Preeclampsia, Gestational Hypertension, Hypertension, Obesity, Overweight and Obesity, Pregnancy Complications
- Being tested
- Home Blood Pressure Monitoring, Heart Health 4 New Moms, Usual care
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Hypertension, Obesity, Overweight, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Blood Pressure MonitoringBehavioural
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 MomsBehavioural
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).
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Home Blood Pressure Monitoring; Behavioral: Heart Health 4 New Moms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
weight change between two study visits
Measured: 4-8 weeks postpartum to 8-12 months postpartum
Secondary outcomes (3)
Systolic blood pressure
Systolic blood pressure at study visit 2
Measured: 8-12 months postpartum
Diastolic blood pressure
Diastolic blood pressure at study visit 2
Measured: 8-12 months postpartum
Hypertension
Proportion of women with hypertension by AHA guidelines
Measured: 8-12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start26 Jan 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alisse Hauspurg, University of Pittsburgh
- Investigators
- Alisse Hauspurg, MD, Principal investigator, Magee-Womens Hospital of University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749746
- Sponsor's protocol ID
- 18080007
- Acronym
- HH4NM
- Status last verified
- Dec 2021
- First submitted
- 20 Nov 2018
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hart R, Demirci J, Countouris M, Sen S, Catov JM, Hauspurg A. Association of Lactation Initiation and Duration with Blood Pressure Recovery in Individuals with a Hypertensive Disorder of Pregnancy. J Womens Health (Larchmt). 2026 Sep;35(9):840-848. doi: 10.1177/15409996261445556. Epub 2026 Apr 18.
PubMed 41999191Hauspurg 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.
PubMed 38073563
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03749746
- Acronym / sponsor ID
- HH4NM / 18080007
- Conditions
- Preeclampsia, Gestational Hypertension, Hypertension, Obesity, Overweight and Obesity, Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 26 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careParticipants 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 | Experimental | Behavioral: Home Blood Pressure MonitoringIn 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 | Experimental | Behavioral: Home Blood Pressure Monitoring, Behavioral: Heart Health 4 New MomsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pre-pregnancy body mass index ≥25 kg/m2
- diagnosed with preeclampsia or gestational hypertension
- access to internet
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Blood Pressure MonitoringEach 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. | Behavioural | Heart Health 4 New Moms, Home Blood Pressure Monitoring |
| Heart Health 4 New MomsThe 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). | Behavioural | Heart Health 4 New Moms |
| Usual careParticipants 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 |
Primary outcome
Weight loss
Time frame: 4-8 weeks postpartum to 8-12 months postpartum
weight change between two study visits
3 secondary outcomes
Systolic blood pressure
Time frame: 8-12 months postpartum
Diastolic blood pressure
Time frame: 8-12 months postpartum
Hypertension
Time frame: 8-12 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Derived from this study: PubMed 41999191Hart R, Demirci J, Countouris M, Sen S, Catov JM, Hauspurg A. Association of Lactation Initiation and Duration with Blood Pressure Recovery in Individuals with a Hypertensive Disorder of Pregnancy. J Womens Health (Larchmt). 2026 Sep;35(9):840-848. doi: 10.1177/15409996261445556. Epub 2026 Apr 18.
- Derived from this study: PubMed 38073563Hauspurg 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.
- Individual participant dataSharing planned: No
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Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisse Hauspurg, MD principal investigator
Magee-Womens Hospital of University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Blood Pressure Monitoring and Heart Health 4 New Moms in people with Preeclampsia and Gestational Hypertension, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 4-8 weeks postpartum to 8-12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.