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EMPower: Electronic Media Powering Positive Health Changes in Youth
This study is currently recruiting participants.
Verified March 2017 by Tammy M. Brady, Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Tammy M. Brady, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02444689
First received: May 12, 2015
Last updated: March 9, 2017
Last verified: March 2017
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Purpose
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 | Intervention |
|---|---|
| Hypertension Prehypertension Overweight Obesity Hypertrophy, Left Ventricular | Behavioral: Electronic Media Application Behavioral: Standard of care education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
Further study details as provided by Tammy M. Brady, Johns Hopkins University:
Primary Outcome Measures:
- Change in adiposity as measured by change in BMI z-score [ Time Frame: 6 months from date of randomization ]
Secondary Outcome Measures:
- Change in clinic systolic blood pressure [ Time Frame: 6 months from date of randomization ]
- Change in left ventricular mass index [ Time Frame: 6 months from date of randomization ]
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2015 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 13 Years to 22 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Overweight or Obese
- Speaks English
Exclusion Criteria:
- No smart phone / smart phone data plan
- Not willing to send/ receive SMS 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02444689
Please refer to this study by its ClinicalTrials.gov identifier: NCT02444689
Contacts
| Contact: Tammy M Brady, M.D., Ph.D | 410.955.2467 | tbrady8@jhmi.edu | |
| Contact: Study Staff | EMPower@jhmi.edu |
Locations
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Tammy Brady, MD, PhD 410-955-2467 tbrady8@jhmi.edu | |
| Contact: Leah Medrano, BS 443-287-9043 lmedran1@jhmi.edu | |
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
More Information
Additional Information:
| Responsible Party: | Tammy M. Brady, Assistant Professor Pediatric Nephrology, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT02444689 History of Changes |
| Other Study ID Numbers: |
IRB00065277 1K23HL119622-01A1 ( U.S. NIH Grant/Contract ) |
| Study First Received: | May 12, 2015 |
| Last Updated: | March 9, 2017 |
Keywords provided by Tammy M. Brady, Johns Hopkins University:
|
Blood pressure Cardiovascular disease Children |
Adolescent Pediatrics End-organ damage |
Additional relevant MeSH terms:
|
Overweight Hypertrophy Prehypertension Hypertrophy, Left Ventricular Body Weight Signs and Symptoms |
Pathological Conditions, Anatomical Vascular Diseases Cardiovascular Diseases Cardiomegaly Heart Diseases |
ClinicalTrials.gov processed this record on July 13, 2017