Back to resultsEMPower: 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
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
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
NCT ID
NCT02444689
First Posted
May 12, 2015
Last Updated
March 11, 2020
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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
Learn more about this trial
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