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EMPower: Electronic Media Powering Positive Health Changes in Youth

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ClinicalTrials.gov Identifier: NCT02444689
Recruitment Status : Recruiting
First Posted : May 14, 2015
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Prehypertension Overweight Obesity Hypertrophy, Left Ventricular Behavioral: Electronic Media Application Behavioral: Standard of care education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Electronic Media Application
Participants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise.
 Behavioral: Electronic Media Application
Children in the intervention group will receive motivation, education and coaching regarding therapeutic lifestyle changes via a smart phone electronic media application.
Active Comparator: Control
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in adiposity as measured by change in BMI z-score [ Time Frame: 6 months from date of randomization ]

Secondary Outcome Measures :
  1. Change in clinic systolic blood pressure [ Time Frame: 6 months from date of randomization ]
  2. Change in left ventricular mass index [ Time Frame: 6 months from date of randomization ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444689


Contacts
Contact: Tammy M Brady, M.D., Ph.D 410.955.2467 tbrady8@jhmi.edu
Contact: Study Staff EMPower@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tammy Brady, MD, PhD    410-955-2467    tbrady8@jhmi.edu   
Contact: Leah Medrano, BS    443-287-9043    lmedran1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Additional Information:
Please visit the study website for more information.  This link exits the ClinicalTrials.gov site

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02444689     History of Changes
Other Study ID Numbers: IRB00065277
1K23HL119622-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Keywords provided by Johns Hopkins University:
Blood pressure
Cardiovascular disease
Children
 Adolescent
Pediatrics
End-organ damage

Additional relevant MeSH terms:
Overweight
Hypertrophy
Prehypertension
Hypertrophy, Left Ventricular
Body Weight
Signs and Symptoms
 Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases
Cardiomegaly
Heart Diseases