Skip to content

Youth-Led Intervention to Improve Blood Pressure

A Youth-Led Digital Education Intervention to Improve Blood Pressure for Hypertensive Adults Who Present to the Emergency Department

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05029687
Enrollment
64
Registered
2021-08-31
Start date
2021-10-31
Completion date
2023-06-30
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Health Knowledge, Attitudes, Practice, Hypertension

Brief summary

The proposed study will develop, test, and collect implementation data on a youth-led hypertension (HTN) education intervention, which will act as an electronic tool to guide youth through learning and then teaching adults on how to achieve better HTN control. Adults with HTN and youth will be recruited for user-centered design sessions to provide input in the development of a youth-led HTN education digital badge. The investigators will then recruit adult emergency department (ED) patients with uncontrolled HTN (blood pressure (BP) ≥130/80 mm Hg) who know (friend or family member) a youth (14-24 years old) and the youth themselves for a RCT. The adult plus youth dyad will be randomized to either: 1) intervention arm- 6-week youth-led HTN education digital badge at home- or 2) control arm- 6-week youth job readiness digital badge at home. In addition to the primary study outcome of adult BP change 2-months post-intervention, the investigator will collect secondary outcomes of HTN knowledge and youth self-efficacy, as well as implementation metrics of intervention acceptability, feasibility, and fidelity. Due to challenges recruiting youth through adults in the ED, we will be adding a cohort to the study where we will recruit interested youth from New Brunswick Health Sciences Technology High School (NBHSTHS). Specific aims are: Aim 1: Create a youth-led HTN education digital badge by means of user-centered design methods and community engagement with adults with HTN and youth to obtain input on the contents of the digital badge prior to implementation. Aim 1a: The hypertension knowledge assessment being used in the study has not been used before on youth or Spanish-speaking populations, so the investigators will obtain feedback on the assessment from these groups. Aim 2: Evaluate the effectiveness of a youth-led HTN education digital badge intervention on the primary outcome of mean systolic BP and diastolic BP change in adults with uncontrolled HTN at 2-months post-intervention compared to the control group (for participants recruited from the ED). Additionally, evaluate change in HTN knowledge and youth self-efficacy. Aim 3: Evaluate the implementation process of the youth-led HTN education digital badge by collecting qualitative and quantitative data on acceptability, feasibility, and fidelity of the intervention by participants.

Detailed description

The proposed study will integrate user-centered design, community engagement, and implementation science, with a randomized controlled trial (RCT), to develop, test, and collect implementation data on a youth-led hypertension (HTN) education digital badge. The badge will act as an electronic tool to guide youth through learning and then teaching adults on how to achieve better HTN control. Adults with HTN and youth will be recruited for user-centered design sessions to provide input in the development of a youth-led HTN education digital badge. The investigators will then recruit adult emergency department (ED) patients with uncontrolled HTN (blood pressure (BP) ≥130/80 mm Hg) who know (friend or family member) a youth (14-24 years old) and the youth themselves for a RCT. The adult plus youth dyad will be randomized to either: 1) intervention arm- 6-week youth-led HTN education digital badge at home- or 2) control arm- 6-week youth job readiness digital badge at home. In addition to the primary study outcome of adult BP change 2-months post-intervention, the investigator will collect secondary outcomes of HTN knowledge and youth self-efficacy, as well as implementation metrics of intervention acceptability, feasibility, and fidelity. Due to challenges recruiting youth through adults in the ED, we will be adding a cohort to the study. For this new cohort of the study, we will recruit interested youth from New Brunswick Health Sciences Technology High School (NBHSTHS). Students will be asked to pair themselves with an adult (18+) (preference for adult who has been diagnosed with hypertension, but not mandatory) with an existing relationship with the student where it would be feasible to complete an online module together 1 hour per week for 6 weeks. The adult must be fluent in English or Spanish and the student must be able to speak the fluent language of the adult. We will evaluate the youth-led digital hypertension (HTN) education intervention- an electronic tool to guide youth through learning and then teaching and supporting adults on how to control hypertension (for adults with hypertension) and how to avoid it (for adults without hypertension). Outcomes of interest are HTN knowledge, confidence in HTN management, and health behavior changes in participants, which will be obtained through pre- and post- intervention assessments. We will also be exploring outcomes of participant acceptability, feasibility, and fidelity of the intervention. Specific aims are: Aim 1: Create a youth-led HTN education digital badge by means of user-centered design methods and community engagement with adults with HTN and youth to obtain input on the contents of the digital badge prior to implementation. Aim 1a: The hypertension knowledge assessment being used in the study has not been used before on youth or Spanish-speaking populations, so the investigators will obtain feedback on the assessment from these groups. Aim 2: Evaluate the effectiveness of a youth-led HTN education digital badge intervention on the primary outcome of mean systolic BP and diastolic BP change in adults with uncontrolled HTN at 2-months post-intervention compared to the control group (for participants recruited from the ED). Additionally, evaluate change in HTN knowledge and youth self-efficacy. Aim 3: Evaluate the implementation process of the youth-led HTN education digital badge by collecting qualitative and quantitative data on acceptability, feasibility, and fidelity of the intervention by participants.

Interventions

BEHAVIORALYouth-Led Hypertension Education Digital Intervention

The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Study transitioned from a randomized controlled trial to a single group study. The total participants enrolled in the trial include all aspects of the study (including qualitative focus groups and interviews).

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aim 1: Participants will be youth (15-18 years) and adults (18+ years old) with self-reported HTN diagnosis. * Aim 1a: Participants will be youth (15-18 years) and Spanish-speaking adults (18+ years old) with self-reported HTN diagnosis. * Aim 2: ED cohort: Eligible adult participants will be 18+ year old ED patients with a history of HTN and two high BP (≥ 130/80 mmHg) readings during their ED visit who know a 14-24 year old. The eligible youth participants (14-24- year-old) must have access to the internet or data plan and a smart phone or computer. School cohort: Youth Eligibility: Any interested student at New Brunswick Health Sciences Technology High School. Adult Eligibility: Adult (18+) (preference for adult who has been diagnosed with hypertension) with an existing relationship with the youth where it would be feasible to complete an online module together 1 hour per week for 6 weeks. Fluency in English or Spanish (youth must be able to speak fluent language). * Aim 3: Everyone who consented to the RCT will be asked to complete a questionnaire, regardless of whether they completed the digital badge. Interested participants from the intervention arm will be recruited for the in-depth interviews.

Exclusion criteria

* Aim 1: Age \<15 years, inability to speak fluently in English or Spanish * Aim 1a: Age \<15 years, inability to speak fluently in English or Spanish * Aims 2 and 3: ED cohort: Age \<14 years, inability to speak fluently in English or Spanish, no access to the internet or a data plan and a smart phone or computer. School cohort: People who cannot take part in the study are people who are not able to speak fluently in English or Spanish (youth and adult must be able to speak the same language), and youth with no access to the internet or a data plan and a smart phone or computer. * Aim 3 (interviews): Participants from the control arm will not be eligible for the in-depth interviews.

Design outcomes

Primary

MeasureTime frameDescription
School Cohort: Hypertension Knowledge (Youth and Adult)At end of 6-week intervention, and 1 month post-6-week interventionUsing 21-question assessment adapted from Williams et al.'s 1998 hypertension knowledge tool. Results reported are the mean number of questions correct out of 21.

Secondary

MeasureTime frameDescription
ED Cohort: Hypertension Knowledge (Youth and Adult)Baseline and 1 week and 2 months post-intervention completionUsing assessment adapted from Williams et al.'s 1998 hypertension knowledge tool
ED Cohort: Youth Self-efficacyBaseline and 1 week and 2 months post-intervention completionUsing a 3-item investigator-created assessment tool on confidence in managing high blood pressure
School Cohort: Youth Self-efficacyAt end of 6-week intervention and 1 month post-6-week interventionTo measure youth confidence helping an adult manage hypertension, investigators created a 3-item assessment from 1 (not at all confident) to 10 (totally confident), on confidence to 1) teach, 2) encourage, and 3) help an adult lower their BP. The outcome measure represents the mean for each of the three items.
School Cohort: Adult Blood Pressure Self-careAt end of 6-week intervention and 1 month post-6-week interventionMean using the 10-question Adult Blood Pressure Self-Care Scale (Peters & Templin, 2010), which states: In general, how often are the following statements true about you? on a scale of 1-Never to 7-Always for self-reported frequency of behaviors (e.g. diet, exercise) that control BP. (e.g.: I am eating a low-salt diet each day.)
ED Cohort: Adult Self-efficacy to Manage HTNBaseline and 1 week and 2 months post-intervention completionUsing Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.)
School Cohort: Adult Self-efficacy to Manage HTNAt end of 6-week intervention and 1 month post-6-week interventionMean using the 5-question Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.) which asks about confidence in managing BP control behaviors on a scale of 1-not at all confident to 10-totally confident.
ED Cohort: Adult Blood Pressure Self-careBaseline and 1 week and 2 months post-intervention completionUsing the Adult Blood Pressure Self-Care Scale (Warren-Findlow et al.)

Other

MeasureTime frameDescription
For ED Cohort: Blood Pressure ChangeBaseline to 1 week and 2 months post-intervention completionChange in systolic and diastolic adult blood pressure (in mm Hg)

Countries

United States

Participant flow

Pre-assignment details

Due to recruitment challenges for the ED cohort, Aim 2 of the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort. Additionally, the number of participants represents both members of each dyad (adults and youth) combined.

Participants by arm

ArmCount
Aim 2: School Cohort
The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module. Youth-Led Hypertension Education Digital Intervention: The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.
34
Aim 1 Participants
To develop the youth-led HTN digital intervention, we conducted a formative study to determine acceptable and easily comprehensible ways to present hypertension information to adults with hypertension and optimal ways to engage youth to support adults on how to achieve better hypertension control. After creating an intervention prototype with 6 weekly self-guided hypertension online modules, we recruited 12 youth (adolescents, aged 15-18 years) for 3 focus groups and 10 adult ED patients with hypertension for individual online interviews to garner feedback on the prototype. After completing a brief questionnaire, participants were asked about experiences with hypertension, preferences for a hypertension education intervention, and acceptability, feasibility, obstacles, and solutions for intervention implementation with youth and adults.
22
Aim 2: ED Cohort
We found little success recruiting participants through the emergency department. No participants completed the study and we shifted to recruitment through a local high school (see Aim 2: School Cohort).
4
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up402
Overall StudyWithdrawal by Subject402

Baseline characteristics

CharacteristicAim 2: School CohortTotalAim 2: ED CohortAim 1 Participants
Adult- Blood Pressure Self-Care Scale3.8 units on a scale
STANDARD_DEVIATION 1
3.9 units on a scale
STANDARD_DEVIATION 0.9
4.6 units on a scale
STANDARD_DEVIATION 0.4
Adult Self-Efficacy to Manage Hypertension Scale6.2 units on a scale
STANDARD_DEVIATION 3.1
6.1 units on a scale
STANDARD_DEVIATION 3.4
5.8 units on a scale
STANDARD_DEVIATION 4
Age, Continuous
Adults
43.3 years
STANDARD_DEVIATION 4.7
47.2 years
STANDARD_DEVIATION 12.5
61.5 years
STANDARD_DEVIATION 20.5
49.8 years
STANDARD_DEVIATION 17
Age, Continuous
Youth
15.5 years
STANDARD_DEVIATION 1.1
15.9 years
STANDARD_DEVIATION 1.6
20.0 years
STANDARD_DEVIATION 4.2
15.9 years
STANDARD_DEVIATION 0.8
HTN Knowledge
Adults
12.3 questions correct out of 21 total
STANDARD_DEVIATION 4
12.5 questions correct out of 21 total
STANDARD_DEVIATION 4.3
14 questions correct out of 21 total
STANDARD_DEVIATION 7.1
HTN Knowledge
Youth
13.0 questions correct out of 21 total
STANDARD_DEVIATION 3.2
13.2 questions correct out of 21 total
STANDARD_DEVIATION 3.2
15 questions correct out of 21 total
STANDARD_DEVIATION 2.8
Race (NIH/OMB)
Adults
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adults
Asian
1 Participants6 Participants1 Participants4 Participants
Race (NIH/OMB)
Adults
Black or African American
0 Participants2 Participants1 Participants1 Participants
Race (NIH/OMB)
Adults
More than one race
1 Participants2 Participants0 Participants1 Participants
Race (NIH/OMB)
Adults
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adults
Unknown or Not Reported
11 Participants11 Participants0 Participants0 Participants
Race (NIH/OMB)
Adults
White
4 Participants8 Participants0 Participants4 Participants
Race (NIH/OMB)
Youth
American Indian or Alaska Native
2 Participants2 Participants0 Participants0 Participants
Race (NIH/OMB)
Youth
Asian
1 Participants3 Participants1 Participants1 Participants
Race (NIH/OMB)
Youth
Black or African American
0 Participants2 Participants1 Participants1 Participants
Race (NIH/OMB)
Youth
More than one race
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Youth
Native Hawaiian or Other Pacific Islander
2 Participants2 Participants0 Participants0 Participants
Race (NIH/OMB)
Youth
Unknown or Not Reported
3 Participants9 Participants0 Participants6 Participants
Race (NIH/OMB)
Youth
White
8 Participants12 Participants0 Participants4 Participants
Sex: Female, Male
Adults
Female
13 Participants19 Participants2 Participants4 Participants
Sex: Female, Male
Adults
Male
4 Participants10 Participants0 Participants6 Participants
Sex: Female, Male
Youth
Female
17 Participants25 Participants1 Participants7 Participants
Sex: Female, Male
Youth
Male
0 Participants6 Participants1 Participants5 Participants
Youth- Confidence in Managing High Blood Pressure
Encourage an adult to lower their high BP.
6.9 units on a scale
STANDARD_DEVIATION 2.9
7.0 units on a scale
STANDARD_DEVIATION 2.9
8 units on a scale
STANDARD_DEVIATION 2.8
Youth- Confidence in Managing High Blood Pressure
Help an adult lower their BP.
6.2 units on a scale
STANDARD_DEVIATION 3.4
6.4 units on a scale
STANDARD_DEVIATION 3.3
8 units on a scale
STANDARD_DEVIATION 2.8
Youth- Confidence in Managing High Blood Pressure
Teach an adult how to lower their high BP.
5.6 units on a scale
STANDARD_DEVIATION 3.2
5.9 units on a scale
STANDARD_DEVIATION 3.2
8 units on a scale
STANDARD_DEVIATION 2.8

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 38
other
Total, other adverse events
0 / 38
serious
Total, serious adverse events
0 / 38

Outcome results

Primary

School Cohort: Hypertension Knowledge (Youth and Adult)

Using 21-question assessment adapted from Williams et al.'s 1998 hypertension knowledge tool. Results reported are the mean number of questions correct out of 21.

Time frame: At end of 6-week intervention, and 1 month post-6-week intervention

Population: High Blood Pressure Knowledge (# correct responses), Mean (SD), \[95% CI\]

ArmMeasureGroupValue (MEAN)Dispersion
YouthSchool Cohort: Hypertension Knowledge (Youth and Adult)At end of 6-week intervention17.5 number of questions correct out of 21Standard Deviation 1.5
YouthSchool Cohort: Hypertension Knowledge (Youth and Adult)1 month post-6-week intervention17.9 number of questions correct out of 21Standard Deviation 2.7
AdultsSchool Cohort: Hypertension Knowledge (Youth and Adult)At end of 6-week intervention17.6 number of questions correct out of 21Standard Deviation 1.7
AdultsSchool Cohort: Hypertension Knowledge (Youth and Adult)1 month post-6-week intervention17.8 number of questions correct out of 21Standard Deviation 2.4
Comparison: Comparison of effect size: baseline to post-intervention (d1)
Comparison: Comparison of effect size: baseline to post-intervention (d2)
Comparison: Comparison of effect size: baseline to 1-month post-intervention (d1)
Comparison: Comparison of effect size: baseline to 1-month post-intervention (d2)
Comparison: Comparison of effect size: baseline to post-intervention (d1)
Comparison: Comparison of effect size: baseline to post-intervention (d2)
Comparison: Comparison of effect size: baseline to 1-month post-intervention (d1)
Comparison: Comparison of effect size: baseline to 1-month post-intervention (d2)
Secondary

ED Cohort: Adult Blood Pressure Self-care

Using the Adult Blood Pressure Self-Care Scale (Warren-Findlow et al.)

Time frame: Baseline and 1 week and 2 months post-intervention completion

Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort.~No participants enrolled in the ED cohort completed the study (1 dyad- 1 adult and 1 youth were lost to follow-up and 1 dyad- 1 adult and 1 youth discontinued the intervention). No outcome data were collected from the ED cohort.

Secondary

ED Cohort: Adult Self-efficacy to Manage HTN

Using Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.)

Time frame: Baseline and 1 week and 2 months post-intervention completion

Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort.~No participants enrolled in the ED cohort completed the study (1 dyad- 1 adult and 1 youth were lost to follow-up and 1 dyad- 1 adult and 1 youth discontinued the intervention). No outcome data were collected from the ED cohort.

Secondary

ED Cohort: Hypertension Knowledge (Youth and Adult)

Using assessment adapted from Williams et al.'s 1998 hypertension knowledge tool

Time frame: Baseline and 1 week and 2 months post-intervention completion

Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort.~No participants enrolled in the ED cohort completed the study (1 dyad- 1 adult and 1 youth were lost to follow-up and 1 dyad- 1 adult and 1 youth discontinued the intervention). No outcome data were collected from the ED cohort.

Secondary

ED Cohort: Youth Self-efficacy

Using a 3-item investigator-created assessment tool on confidence in managing high blood pressure

Time frame: Baseline and 1 week and 2 months post-intervention completion

Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort.~No participants enrolled in the ED cohort completed the study (1 dyad- 1 adult and 1 youth were lost to follow-up and 1 dyad- 1 adult and 1 youth discontinued the intervention). No outcome data were collected from the ED cohort.

Secondary

School Cohort: Adult Blood Pressure Self-care

Mean using the 10-question Adult Blood Pressure Self-Care Scale (Peters & Templin, 2010), which states: In general, how often are the following statements true about you? on a scale of 1-Never to 7-Always for self-reported frequency of behaviors (e.g. diet, exercise) that control BP. (e.g.: I am eating a low-salt diet each day.)

Time frame: At end of 6-week intervention and 1 month post-6-week intervention

ArmMeasureValue (MEAN)Dispersion
YouthSchool Cohort: Adult Blood Pressure Self-care4.9 score on a scaleStandard Deviation 1.2
AdultsSchool Cohort: Adult Blood Pressure Self-care5.2 score on a scaleStandard Deviation 0.9
Comparison: Comparison of effect size: baseline to post-intervention (d1)
Comparison: Comparison of effect size: baseline to post-intervention (d2)
Comparison: Comparison of effect size: baseline to 1-month post-intervention (d1)
Comparison: Comparison of effect size: baseline to 1-month post-intervention (d2)
Secondary

School Cohort: Adult Self-efficacy to Manage HTN

Mean using the 5-question Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.) which asks about confidence in managing BP control behaviors on a scale of 1-not at all confident to 10-totally confident.

Time frame: At end of 6-week intervention and 1 month post-6-week intervention

ArmMeasureValue (MEAN)Dispersion
YouthSchool Cohort: Adult Self-efficacy to Manage HTN8.1 score on a scaleStandard Deviation 1.7
AdultsSchool Cohort: Adult Self-efficacy to Manage HTN8.5 score on a scaleStandard Deviation 1.4
Comparison: Comparison of effect size: baseline to post-intervention (d1)
Comparison: Comparison of effect size: baseline to post-intervention (d2)
Comparison: Comparison of effect size: baseline to 1-month post-intervention (d1)
Comparison: Comparison of effect size: baseline to 1-month post-intervention (d2)
Secondary

School Cohort: Youth Self-efficacy

To measure youth confidence helping an adult manage hypertension, investigators created a 3-item assessment from 1 (not at all confident) to 10 (totally confident), on confidence to 1) teach, 2) encourage, and 3) help an adult lower their BP. The outcome measure represents the mean for each of the three items.

Time frame: At end of 6-week intervention and 1 month post-6-week intervention

Population: Participants completed the assessment at post-intervention and 1-month post-intervention.

ArmMeasureGroupValue (MEAN)Dispersion
YouthSchool Cohort: Youth Self-efficacyTeach an adult how to lower their BP.8.2 score on a scaleStandard Deviation 1.3
YouthSchool Cohort: Youth Self-efficacyEncourage an adult to lower their high BP.8.9 score on a scaleStandard Deviation 1
YouthSchool Cohort: Youth Self-efficacyHelp an adult lower their BP.8.8 score on a scaleStandard Deviation 1.6
AdultsSchool Cohort: Youth Self-efficacyTeach an adult how to lower their BP.8.7 score on a scaleStandard Deviation 1.4
AdultsSchool Cohort: Youth Self-efficacyEncourage an adult to lower their high BP.9.0 score on a scaleStandard Deviation 1.2
AdultsSchool Cohort: Youth Self-efficacyHelp an adult lower their BP.9.0 score on a scaleStandard Deviation 1.3
Comparison: Comparison of effect size: baseline to post-intervention for the statement: Teach an adult how to lower their high BP. (d1)
Comparison: Comparison of effect size: baseline to post-intervention for the statement: Teach an adult how to lower their high BP. (d2)
Comparison: Comparison of effect size: baseline to 1-month post-intervention for the statement: Teach an adult how to lower their high BP. (d1)
Comparison: Comparison of effect size: baseline to 1-month post-intervention for the statement: Teach an adult how to lower their high BP. (d2)
Comparison: Comparison of effect size: baseline to post-intervention for the statement: Encourage an adult to lower their high BP. (d1)
Comparison: Comparison of effect size: baseline to post-intervention for the statement: Encourage an adult to lower their high BP. (d2)
Comparison: Comparison of effect size: baseline to 1-month post-intervention for the statement: Encourage an adult to lower their high BP. (d1)
Comparison: Comparison of effect size: baseline to 1-month post-intervention for the statement: Encourage an adult to lower their high BP. (d2)
Comparison: Comparison of effect size: baseline to post-intervention for the statement: Help an adult lower their BP. (d1)
Comparison: Comparison of effect size: baseline to post-intervention for the statement: Help an adult lower their BP. (d2)
Comparison: Comparison of effect size: baseline to 1-month post-intervention for the statement: Help an adult lower their BP. (d1)
Comparison: Comparison of effect size: baseline to 1-month post-intervention for the statement: Help an adult lower their BP. (d2)
Other Pre-specified

For ED Cohort: Blood Pressure Change

Change in systolic and diastolic adult blood pressure (in mm Hg)

Time frame: Baseline to 1 week and 2 months post-intervention completion

Population: Due to recruitment challenges for the ED cohort, the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort. No outcome data were collected from the ED cohort.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026