EMPower: Electronic Media Powering Positive Health Changes in Youth

Study Overview
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Brief Summary
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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.

Official Title
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EMPower: Electronic Media Powering Positive Health Changes in Youth

Conditions
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Hypertension, Prehypertension, Overweight, Obesity, Hypertrophy, Left Ventricular

Intervention / Treatment
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* Behavioral: Electronic Media Application
* Behavioral: Standard of care education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight or Obese Speaks English Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic Media Application<br>Participants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise. | Behavioral: Electronic Media Application<br>* Children in the intervention group will receive motivation, education and coaching regarding therapeutic lifestyle changes via a smart phone electronic media application.<br>|
| Active Comparator: Control<br>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. | Behavioral: Standard of care education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adiposity as measured by change in BMI z-score |  | 6 months from date of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinic systolic blood pressure |  | 6 months from date of randomization | 
| Change in left ventricular mass index |  | 6 months from date of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Cardiovascular disease, Children, Adolescent, Pediatrics, End-organ damage