EMPower: Electronic Media Powering Positive Health Changes in Youth

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT02444689

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

56.2

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

EMPower: Electronic Media Powering Positive Health Changes in Youth

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Mar 6, 2020

Actual Study Completion Date :

Mar 6, 2020

Arms and Interventions

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

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

Primary Outcome Measures

Change in adiposity as measured by change in BMI z-score [6 months from date of randomization]

Secondary Outcome Measures

Change in clinic systolic blood pressure [6 months from date of randomization]
Change in left ventricular mass index [6 months from date of randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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