EMPower: Electronic Media Powering Positive Health Changes in Youth

Not Applicable

Completed

• Conditions: Prehypertension; Obesity; Hypertension; Overweight; Hypertrophy, Left Ventricular
• Interventions: Behavioral: Electronic Media Application; Behavioral: Standard of care education

• Registration Number: NCT02444689
• Lead Sponsor: Johns Hopkins University

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 available

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Study Start: 2015-07
• Status Verified: 2020-03
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-06
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic Media Application	Electronic Media Application	Participants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise.
Control	Standard of care education	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.

Primary Outcome Measures

Name	Time	Method
Change in adiposity as measured by change in BMI z-score	6 months from date of randomization

Secondary Outcome Measures

Name	Time	Method
Change in clinic systolic blood pressure	6 months from date of randomization
Change in left ventricular mass index	6 months from date of randomization

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States