EMPower: Electronic Media Powering Positive Health Changes in Youth

Obesity Clinical Trial

Official title:

EMPower: Electronic Media Powering Positive Health Changes in Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444689
• Other study ID #: IRB00065277
• Secondary ID: 1K23HL119622-01A
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: March 6, 2020

Study information

• Verified date: March 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Standard of care education

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in adiposity as measured by change in BMI z-score		6 months from date of randomization
Secondary	Change in clinic systolic blood pressure		6 months from date of randomization
Secondary	Change in left ventricular mass index		6 months from date of randomization

External Links

•   Please visit the study website for more information.