EMPower: Electronic Media Powering Positive Health Changes in Youth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02444689|
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : March 12, 2020
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EMPower: Electronic Media Powering Positive Health Changes in Youth|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||March 6, 2020|
|Actual Study Completion Date :||March 6, 2020|
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
- Change in adiposity as measured by change in BMI z-score [ Time Frame: 6 months from date of randomization ]
- 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 ]
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
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Tammy M Brady, M.D., Ph.D||Johns Hopkins University|