N/A N=316 Randomized Double-blind Treatment

Young Adult Hypertension Self-Management Clinical Trial

Hypertension · Blood Pressure · Lifestyle Risk Reduction

Bottom Line

View on ClinicalTrials.gov: NCT03158051 ↗

Enrolled (actual)

316

Serious AEs

2.5%

Results posted

May 2023

Primary outcome: Primary: 24-hour Systolic Ambulatory Blood Pressure (mmHg) — 132.59; 133.01; 128.14; 130.69 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Home Blood Pressure Monitoring (Behavioral); Telephone Health Coaching (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY 24-hour Systolic Ambulatory Blood Pressure (mmHg)	132.59; 133.01; 128.14; 130.69; 128.54; 129.47	—
PRIMARY 24-hour Diastolic Ambulatory Blood Pressure (mmHg)	86.45; 87.04; 84.61; 85.89; 85.34; 85.52	—
PRIMARY Clinic Systolic Blood Pressure (mmHg)	138.30; 137.97; 130.84; 132.50; 131.16; 130.7	—
PRIMARY Clinic Diastolic Blood Pressure (mmHg)	90.81; 91.77; 83.83; 86.70; 85.05; 85.15	—
SECONDARY Number of Participants That Achieve Hypertension Control at 6 Months	20; 21; 60; 60	—
SECONDARY Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment	3512.82; 3672.81; 3354.72; 3968.20; 3682.94; 4213.67	—
SECONDARY Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment	2.34; 2.50; 2.43; 2.57; 2.50; 2.55	—
SECONDARY Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment	0.61; 0.85; 0.88; 1.12; 0.82; 1.14	—
SECONDARY Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment	11.91; 12.54; 12.97; 13.12; 12.03; 13.46	—
SECONDARY Physical Activity as Assessed by the Godin Physical Activity Questionnaire	38.24; 37.24; 54.47; 40.69; 46.67; 39.22	—
SECONDARY Home Blood Pressure Monitoring Frequency	109; 118; 23; 20; 13; 17	—
SECONDARY Standing Weight (kg)	102.86; 102.93; 98.54; 103.80; 97.91; 103.45	—
SECONDARY Perceived Competence as Assessed by the Perceived Competence Scale for Diet	4.54; 4.56; 5.04; 4.63; 4.71; 4.70	—
SECONDARY Perceived Competence as Assessed by the Perceived Competence Scale for Exercise	4.83; 5.03; 5.28; 5.01; 4.98; 4.89	—
SECONDARY Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet	4.63; 4.93; 5.35; 5.17; 5.06; 5.22	—
SECONDARY Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise	4.72; 5.00; 5.31; 5.17; 5.11; 5.31	—
SECONDARY Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet	5.80; 5.80; 5.86; 5.76; 5.78; 5.85	—
SECONDARY Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise	5.81; 5.81; 5.94; 5.74; 5.79; 5.83	—
SECONDARY Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet	3.19; 3.04; 3.30; 3.23; 3.36; 3.39	—
SECONDARY Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise	3.20; 3.06; 3.28; 3.29; 3.17; 3.28	—
SECONDARY Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet	2.30; 2.37; 2.29; 2.45; 2.47; 2.35	—
SECONDARY Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise	2.27; 2.31; 2.27; 2.46; 2.55; 2.34	—

Summary

This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.

Eligibility Criteria

Inclusion Criteria

Willing and capable of giving written informed consent
Willing to comply with all study procedures and be available for the duration of the study
Males and females ages 18-39 years old at the start of the study (inclusive)
A minimum of two hypertension ICD-10 coded visits with a provider (physician [MD, DO], physician assistant, nurse practitioner) on different dates in the last 24 months, with at least one code in the past 18 months
Medically homed at an IRB approved healthcare system

Exclusion Criteria

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
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
Pregnant or planning to become pregnant in the next 12 months
Planning to leave the geographic area in the next 6 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
White Coat Hypertension (24-hour ambulatory monitoring)
Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators
Prisoners

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03158051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.