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EMPower: Electronic Media Powering Positive Health Changes in Youth

Primary Purpose

Hypertension, Prehypertension, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Media Application
Standard of care education
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Blood pressure, Cardiovascular disease, Children, Adolescent, Pediatrics, End-organ damage

Eligibility Criteria

13 Years - 22 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electronic Media Application

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in adiposity as measured by change in BMI z-score

Secondary Outcome Measures

Change in clinic systolic blood pressure
Change in left ventricular mass index

Full Information

First Posted
May 12, 2015
Last Updated
March 11, 2020
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02444689
Brief Title
EMPower: Electronic Media Powering Positive Health Changes in Youth
Official Title
EMPower: Electronic Media Powering Positive Health Changes in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Prehypertension, Overweight, Obesity, Hypertrophy, Left Ventricular
Keywords
Blood pressure, Cardiovascular disease, Children, Adolescent, Pediatrics, End-organ damage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic Media Application
Arm Type
Experimental
Arm Description
Participants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Media Application
Intervention Description
Children in the intervention group will receive motivation, education and coaching regarding therapeutic lifestyle changes via a smart phone electronic media application.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care education
Primary Outcome Measure Information:
Title
Change in adiposity as measured by change in BMI z-score
Time Frame
6 months from date of randomization
Secondary Outcome Measure Information:
Title
Change in clinic systolic blood pressure
Time Frame
6 months from date of randomization
Title
Change in left ventricular mass index
Time Frame
6 months from date of randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy M Brady, M.D., Ph.D
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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