An interventional study of Health Coaching and Home Blood Pressure Monitoring in Hypertension, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Prevention
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.
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.
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.
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.
Aim 1-3: A total of 140 participants will be enrolled and randomly assigned to the intervention and usual care arms.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 140 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Health Coaching · Other: Home Blood Pressure Monitoring
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.
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
Number of Participants Who Attend 12 month Postpartum Care Visit
Time frame: up to 12 months
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 and 12 months
Plan to share: Yes
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University of Wisconsin, Madison