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OpenTrials
Completed

NCT Number: NCT02444689

EMPower: Electronic Media Powering Positive Health Changes in Youth

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.

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Key information

Conditions

Hypertension Body Weight Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prehypertension Signs and Symptoms Vascular Diseases

Age range

13 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Media Application

Behavioral

Children in the intervention group will receive motivation, education and coaching regarding therapeutic lifestyle changes via a smart phone electronic media application.

Standard of care education

Behavioral

Primary outcomes

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

    Time frame: 6 months from date of randomization

Secondary outcomes

  1. Change in clinic systolic blood pressure

    Time frame: 6 months from date of randomization

  2. Change in left ventricular mass index

    Time frame: 6 months from date of randomization

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 14, 2015
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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