HypertensionSTAC-MyHEARTpNCT05685251
Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum
A study testing Health Coaching and Home Blood Pressure Monitoring in people with Hypertension, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
A study of Staying Healthy After Childbirth (STAC) and My Hypertension Education And Reaching Target (MyHEART) for postpartum (p) patients to determine if health coaching can increase 12-month postpartum care attendance, hypertension control and hypertension self-management behavior compared to usual clinical care in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Health Coaching and Home Blood Pressure Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 10 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and capable of giving written informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Genetically female
- Patients who complete the 6-week program, had a hypertension disorder of pregnancy who have persistent hypertension (systolic blood pressure greater than 130 mmHg or diastolic blood pressure greater than 80 mmHg) and/or are still on antihypertensive medication and those with chronic hypertension (CHTN) will be eligible to participate.
- Medically homed at UW Health or UPH
Who cannot join
- Inability to participate in health coaching (i.e., no reliable phone contact or Wi-Fi
- History of medically determined Congestive Heart Failure
- Unable to provide informed consent (i.e., activated healthcare power of attorney)
- Unable or unwilling to travel to local clinic for research visits
- Currently residing in a skilled nursing facility
- Diagnosed with sickle cell anemia or cystic fibrosis
Show all 23Show fewer
- Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years
- Syncope while exercising or doing strenuous activity within past 12 months
- Currently prescribed warfarin, novel oral anticoagulant, or insulin
- Planned organ transplant or prior transplant in the past 5 years
- Chemotherapy or radiation therapy within 6 the past months
- Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment
- Current participation or planning to participate in another clinical trial in the next 12 months that involves hypertension management/control
- Pregnant or planning to become pregnant in the next 12 months
- Planning to leave the geographic area in the next 12 months
- Health condition that will limit both increasing physical activity and changing diet
- Illegal drug use (other than marijuana) in the past 30 days
- Unable to read or communicate in English
- Currently on dialysis or seeing a Nephrologist
- Unaware or denies history of high blood pressure or hypertension
- Between-arm blood pressure difference >20 mmHg
- Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum (STAC-MyHEARTp)
A study of Staying Healthy After Childbirth (STAC) and My Hypertension Education And Reaching Target (MyHEART) for postpartum (p) patients to determine if health coaching can increase 12-month postpartum care attendance, hypertension control and hypertension self-management behavior compared to usual clinical care in patients with chronic hypertension or persistent pregnancy associated hypertension - postpartum. 140 participants will be enrolled and can expect to be on study for 12 months.
Read the detailed description
To address the critical need for hypertension (HTN) control in young adults, the investigators developed the MyHEART (My Hypertension Education And Reaching Target) program, a multi-component patient-centered, theoretically-based intervention designed to increase self-management using evidence-based health behavior approaches to lower BP among young adults with uncontrolled HTN.
A nonrandomized, single-center pilot study of MyHEART was conducted, which established feasibility, satisfaction, and informed the design of this trial. A large, multi-site randomized-controlled trial to evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and HTN control (secondary) after 6 and 12 months, compared to usual clinical care was completed. Additionally, lifestyle changes and HTN self-management behavior were evaluated.
Incorporating components of the MyHEART intervention with routine clinical care can support HTN behavioral changes in young adults with uncontrolled HTN to support BP lowering in this population. The investigators are in a unique position to partner with the Perinatal Clinic and the current STAC program, to improve health outcomes for women with HTN during pregnancy through health coaching and BP surveillance through 12-months postpartum.
Specific Aims:
- Aim 1: To improve postpartum attendance for 12-month hypertension follow-up care among Staying Healthy After Childbirth patients who have chronic hypertension or persistent hypertension at 6-weeks postpartum.
- Hypothesis: Postpartum follow up care will improve in the intervention compared to usual care.
- Aim 2: To improve blood pressure control at 12-months in postpartum patients with chronic hypertension or a hypertension disorder of pregnancy with persistent HTN at 6-weeks postpartum.
- Hypothesis: Blood pressure control will improve in the intervention (health coaching) arm compared to the usual care arm, via chart review from the 12-month postpartum appointment, and on ambulatory blood pressure monitoring compared to usual care.
- Aim 3: To increase lifestyle modification behaviors and health outcomes relating to nutrition and physical activity and cardiovascular disease (CVD) prevention in postpartum patients with chronic hypertension or a hypertension disorder of pregnancy with persistent HTN at 6-weeks postpartum.
- Hypothesis: Health outcomes including, weight, lipid profile, A1c and microalbumin creatine ratio will improve in the intervention compared to usual care arm, via study surveys and upon chart review from the 12-month postpartum appointment.
Aim 1-3: A total of 140 participants will be enrolled and randomly assigned to the intervention and usual care arms.
- Conditions
- Hypertension
- Being tested
- Health Coaching, Home Blood Pressure Monitoring
- Keywords
- postpartum, chronic hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingOther
Participants will receive a health coach telehealth/video visit or phone call every 2 weeks for 4 months, for a total of 8 calls. After these initial 8 calls, at approximately 6 months postpartum, the health coach will schedule maintenance calls 1 per month until approximately 12 months postpartum, for a total of 6 additional calls.
Home Blood Pressure MonitoringOther
Participants will be provided an A\&D UA-651 (BT) home blood pressure monitor with an appropriate cuff size, they will be asked to take their blood pressure at least three days a week, 2 measurements each time
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Not described Receives: Other: Health Coaching; Other: Home Blood Pressure Monitoring |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Attend 12 month Postpartum Care Visit
Measured: up to 12 months
Secondary outcomes (12)
Difference in Self-Reported and Electronic Medical Record (EMR) documented BP at 6 months postpartum
Measured: up to 6 months
Lipid Profile at 12 months postpartum
Measured: 12 months
Hemoglobin A1c at 12 months postpartum
Measured: 12 months
Microalbumin Creatine Ratio at 12 months postpartum
Measured: 12 months
Percentage of participants that achieve hypertension control at 12 months postpartum
Hypertension control will be defined using ambulatory blood pressures as the gold standard (less than 130/80 mmHg); otherwise a clinic blood pressure of less than 140/90 mmHg will be used.
Measured: 12 months
Hypertension Control: Number of Participants who initiate, titrate, or cease BP medications
Measured: up to 12 months
Hypertension Control: Summary of Antihypertensive Type
Measured: up to 12 months
Dietary Changes: Change in Sodium intake (milligrams/day) as assessed by the Automated Self-Administered 24-hour Dietary Assessment
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by dietary changes documented on an automated self-administered 24 hour dietary assessment.
Measured: 6 and 12 months
Change in physical activity as measured by the Godin Physical Activity Questionnaire
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by change in physical activity as measured by the Godin Physical Activity Questionnaire at 6 and 12 months. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. A score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active.
Measured: 6 and 12 months
Change in Home Blood Pressure Monitoring Frequency
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by measuring the frequency of home blood pressure monitoring.
Measured: 6 and 12 months
Change in Weight (kg)
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by documenting participant weight at 6 and 12 months.
Measured: 6 and 12 months
Change in Body Mass Index (BMI)
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by documenting participant BMI at 6 and 12 months.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start22 Feb 2023
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Model description
- A randomized, single-center study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Meriter Foundation
- Responsible party
- Sponsor
- Investigators
- Kara K Hoppe, DO, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685251
- Sponsor's protocol ID
- 2025-0768
- Other IDs
- Protocol Version 5/9/2024
- Acronym
- STAC-MyHEARTp
- Status last verified
- Apr 2025
- First submitted
- 5 Jan 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Knutson Sinaise MR, Buchholz K, Hetzel S, Neal M, Ryser S, Albert E, Hildebrandt K, Johnson HM, Hoppe KK. Care Navigation, Self-Measured Blood Pressure, and Health Coaching for Postpartum Care: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2626970. doi: 10.1001/jamanetworkopen.2026.26970.
PubMed 42566217
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum (STAC-MyHEARTp)
- ClinicalTrials.gov ID
- NCT05685251
- Acronym / sponsor ID
- STAC-MyHEARTp / 2025-0768
- Conditions
- Hypertension
- Keywords
- postpartum, chronic hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Meriter Foundation
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 17 Jan 2023 (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.
A study of Staying Healthy After Childbirth (STAC) and My Hypertension Education And Reaching Target (MyHEART) for postpartum (p) patients to determine if health coaching can increase 12-month postpartum care attendance, hypertension control and hypertension self-management behavior compared to usual clinical care in patients with chronic hypertension or persistent pregnancy associated hypertension - postpartum. 140 participants will be enrolled and can expect to be on study for 12 months.
Detailed description
To address the critical need for hypertension (HTN) control in young adults, the investigators developed the MyHEART (My Hypertension Education And Reaching Target) program, a multi-component patient-centered, theoretically-based intervention designed to increase self-management using evidence-based health behavior approaches to lower BP among young adults with uncontrolled HTN.
A nonrandomized, single-center pilot study of MyHEART was conducted, which established feasibility, satisfaction, and informed the design of this trial. A large, multi-site randomized-controlled trial to evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and HTN control (secondary) after 6 and 12 months, compared to usual clinical care was completed. Additionally, lifestyle changes and HTN self-management behavior were evaluated.
Incorporating components of the MyHEART intervention with routine clinical care can support HTN behavioral changes in young adults with uncontrolled HTN to support BP lowering in this population. The investigators are in a unique position to partner with the Perinatal Clinic and the current STAC program, to improve health outcomes for women with HTN during pregnancy through health coaching and BP surveillance through 12-months postpartum.
Specific Aims:
- Aim 1: To improve postpartum attendance for 12-month hypertension follow-up care among Staying Healthy After Childbirth patients who have chronic hypertension or persistent hypertension at 6-weeks postpartum.
- Hypothesis: Postpartum follow up care will improve in the intervention compared to usual care.
- Aim 2: To improve blood pressure control at 12-months in postpartum patients with chronic hypertension or a hypertension disorder of pregnancy with persistent HTN at 6-weeks postpartum.
- Hypothesis: Blood pressure control will improve in the intervention (health coaching) arm compared to the usual care arm, via chart review from the 12-month postpartum appointment, and on ambulatory blood pressure monitoring compared to usual care.
- Aim 3: To increase lifestyle modification behaviors and health outcomes relating to nutrition and physical activity and cardiovascular disease (CVD) prevention in postpartum patients with chronic hypertension or a hypertension disorder of pregnancy with persistent HTN at 6-weeks postpartum.
- Hypothesis: Health outcomes including, weight, lipid profile, A1c and microalbumin creatine ratio will improve in the intervention compared to usual care arm, via study surveys and upon chart review from the 12-month postpartum appointment.
Aim 1-3: A total of 140 participants will be enrolled and randomly assigned to the intervention and usual care arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, single-center study
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Other: Health Coaching, Other: Home Blood Pressure Monitoring |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and capable of giving written informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Genetically female
- Patients who complete the 6-week program, had a hypertension disorder of pregnancy who have persistent hypertension (systolic blood pressure greater than 130 mmHg or diastolic blood pressure greater than 80 mmHg) and/or are still on antihypertensive medication and those with chronic hypertension (CHTN) will be eligible to participate.
- Medically homed at UW Health or UPH
Key exclusion criteria (23 listed)
- Inability to participate in health coaching (i.e., no reliable phone contact or Wi-Fi
- History of medically determined Congestive Heart Failure
- Unable to provide informed consent (i.e., activated healthcare power of attorney)
- Unable or unwilling to travel to local clinic for research visits
- Currently residing in a skilled nursing facility
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 |
|---|---|---|
| Health CoachingParticipants will receive a health coach telehealth/video visit or phone call every 2 weeks for 4 months, for a total of 8 calls. After these initial 8 calls, at approximately 6 months postpartum, the health coach will schedule maintenance calls 1 per month until approximately 12 months postpartum, for a total of 6 additional calls. | Other | Health Coaching |
| Home Blood Pressure MonitoringParticipants will be provided an A\&D UA-651 (BT) home blood pressure monitor with an appropriate cuff size, they will be asked to take their blood pressure at least three days a week, 2 measurements each time | Other | Health Coaching |
Primary outcome
Number of Participants Who Attend 12 month Postpartum Care Visit
Time frame: up to 12 months
12 secondary outcomes
Difference in Self-Reported and Electronic Medical Record (EMR) documented BP at 6 months postpartum
Time frame: up to 6 months
Lipid Profile at 12 months postpartum
Time frame: 12 months
Hemoglobin A1c at 12 months postpartum
Time frame: 12 months
Microalbumin Creatine Ratio at 12 months postpartum
Time frame: 12 months
Percentage of participants that achieve hypertension control at 12 months postpartum
Time frame: 12 months
Hypertension Control: Number of Participants who initiate, titrate, or cease BP medications
Time frame: up to 12 months
Hypertension Control: Summary of Antihypertensive Type
Time frame: up to 12 months
Dietary Changes: Change in Sodium intake (milligrams/day) as assessed by the Automated Self-Administered 24-hour Dietary Assessment
Time frame: 6 and 12 months
Change in physical activity as measured by the Godin Physical Activity Questionnaire
Time frame: 6 and 12 months
Change in Home Blood Pressure Monitoring Frequency
Time frame: 6 and 12 months
Change in Weight (kg)
Time frame: 6 and 12 months
Change in Body Mass Index (BMI)
Time frame: 6 and 12 months
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 28 Aug 2025.
- Derived from this study: PubMed 42566217Knutson Sinaise MR, Buchholz K, Hetzel S, Neal M, Ryser S, Albert E, Hildebrandt K, Johnson HM, Hoppe KK. Care Navigation, Self-Measured Blood Pressure, and Health Coaching for Postpartum Care: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2626970. doi: 10.1001/jamanetworkopen.2026.26970.
- Individual participant dataSharing planned: Yes
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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.
Kara K Hoppe, DO principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching and Home Blood Pressure Monitoring in people with Hypertension, run by University of Wisconsin, Madison 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 5 inclusion and 23 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 28 Aug 2025. 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?
Number of Participants Who Attend 12 month Postpartum Care Visit (time frame: up to 12 months). 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 NCT05685251, which also lists 1 linked publication.
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 28 Aug 2025.