HypertensionNCT02444689
EMPower: Electronic Media Powering Positive Health Changes in Youth
A study testing Electronic Media Application in people with Hypertension and Prehypertension, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a technology-based behavioral Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean clinic systolic BP), and heart size (LVM) in comparison to standard care. Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Hypertension, Prehypertension, Overweight
- What is being tested?
- Electronic Media Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 6 Mar 2020
- 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 13 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Overweight or Obese
- Speaks English
Who cannot join
- No smart phone / smart phone data plan
- Not willing to send/ receive text messages or download and use the study applications
- Neurological impairment/ developmental delay
- New / changes in anti-hypertensive medication or medication known to affect blood pressure within the last 6 months
- Prior diagnosis of congenital heart disease or cancer
- Pregnancy
- Taking medication with weight gain as a side effect
- Taking medications for weight loss/ participation in another weight loss program
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of a technology-based behavioral Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean clinic systolic BP), and heart size (LVM) in comparison to standard care.
- Being tested
- Electronic Media Application, Standard of care education
- Keywords
- Blood pressure, Cardiovascular disease, Children, Adolescent, Pediatrics, End-organ damage
- Medical subject headings
- Hypertension, Prehypertension, Overweight, Obesity, Hypertrophy, Left Ventricular, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Media ApplicationBehavioural
Children in the intervention group will receive motivation, education and coaching regarding therapeutic lifestyle changes via a smart phone electronic media application.
Standard of care educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Electronic Media Application | Experimental | Participants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise. Receives: Behavioral: Electronic Media Application |
| Control | Active comparator | Participants will receive standard of care education and feedback on how to implement a heart healthy lifestyle to promote weight loss, improved diet quality and exercise. Receives: Behavioral: Standard of care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adiposity as measured by change in BMI z-score
Measured: 6 months from date of randomization
Secondary outcomes (2)
Change in clinic systolic blood pressure
Measured: 6 months from date of randomization
Change in left ventricular mass index
Measured: 6 months from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJul 2015
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Tammy M Brady, M.D., Ph.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444689
- Sponsor's protocol ID
- IRB00065277
- Other IDs
- 1K23HL119622-01A1
- Status last verified
- Mar 2020
- First submitted
- 12 May 2015
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPower: Electronic Media Powering Positive Health Changes in Youth
- ClinicalTrials.gov ID
- NCT02444689
- Acronym / sponsor ID
- IRB00065277
- Keywords
- Blood pressure, Cardiovascular disease, Children, Adolescent, Pediatrics, End-organ damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2015
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
The purpose of this study is to evaluate the effectiveness of a technology-based behavioral Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean clinic systolic BP), and heart size (LVM) in comparison to standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Media Application | Experimental | Behavioral: Electronic Media ApplicationParticipants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise. |
| Control | Active comparator | Behavioral: Standard of care educationParticipants will receive standard of care education and feedback on how to implement a heart healthy lifestyle to promote weight loss, improved diet quality and exercise. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Overweight or Obese
- Speaks English
Key exclusion criteria (8 listed)
- No smart phone / smart phone data plan
- Not willing to send/ receive text messages or download and use the study applications
- Neurological impairment/ developmental delay
- New / changes in anti-hypertensive medication or medication known to affect blood pressure within the last 6 months
- Prior diagnosis of congenital heart disease or cancer
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 |
|---|---|---|
| Electronic Media ApplicationChildren in the intervention group will receive motivation, education and coaching regarding therapeutic lifestyle changes via a smart phone electronic media application. | Behavioural | Electronic Media Application |
| Standard of care education | Behavioural | Control |
Primary outcome
Change in adiposity as measured by change in BMI z-score
Time frame: 6 months from date of randomization
2 secondary outcomes
Change in clinic systolic blood pressure
Time frame: 6 months from date of randomization
Change in left ventricular mass index
Time frame: 6 months from date of randomization
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 12 Mar 2020.
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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.
Tammy M Brady, M.D., Ph.D principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Media Application in people with Hypertension and Prehypertension, run by Johns Hopkins University 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 2 inclusion and 8 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 12 Mar 2020. 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?
Change in adiposity as measured by change in BMI z-score (time frame: 6 months from date of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2020.