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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 : July 23, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE May 12, 2015
First Posted Date  ICMJE May 14, 2015
Last Update Posted Date July 23, 2019
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
Change in adiposity as measured by change in BMI z-score [ Time Frame: 6 months from date of randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02444689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
  • Change in daytime ambulatory 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EMPower: Electronic Media Powering Positive Health Changes in Youth
Official Title  ICMJE EMPower: Electronic Media Powering Positive Health Changes in Youth
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Prehypertension
  • Overweight
  • Obesity
  • Hypertrophy, Left Ventricular
Intervention  ICMJE
  • 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.
  • Behavioral: Standard of care education
Study Arms  ICMJE
  • Experimental: Electronic Media Application
    Participants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise.
    Intervention: Behavioral: 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.
    Intervention: Behavioral: Standard of care education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tammy M Brady, M.D., Ph.D 410.955.2467 tbrady8@jhmi.edu
Contact: Study Staff EMPower@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02444689
Other Study ID Numbers  ICMJE IRB00065277
1K23HL119622-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP