EMPower: Electronic Media Powering Positive Health Changes in Youth

Johns Hopkins University

Status: Completed

Conditions: Hypertension; Overweight; Prehypertension; Hypertrophy, Left Ventricular; Obesity

Treatments: Behavioral: Standard of care education; Behavioral: Electronic Media Application

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02444689

IRB00065277

1K23HL119622-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 13 to 22 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Electronic Media Application

Experimental group

Description:

Participants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise.

Treatment:

Behavioral: Electronic Media Application

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of care education