NCT02444689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

4.7 years

First QC Date

May 12, 2015

Last Update Submit

March 11, 2020

Conditions

HypertensionPrehypertensionOverweightObesityHypertrophy, Left Ventricular

Keywords

Blood pressureCardiovascular diseaseChildrenAdolescentPediatricsEnd-organ damage

Outcome Measures

Primary Outcomes (1)

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

    6 months from date of randomization

Secondary Outcomes (2)

  • Change in clinic systolic blood pressure

    6 months from date of randomization

  • Change in left ventricular mass index

    6 months from date of randomization

Study Arms (2)

Electronic Media Application

EXPERIMENTAL

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

Behavioral: Electronic Media Application

Control

ACTIVE COMPARATOR

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

Interventions

Electronic Media ApplicationBEHAVIORAL

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

Electronic Media Application
Standard of care educationBEHAVIORAL
Control

Eligibility Criteria

Age13 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Overweight or Obese
  • Speaks English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

HypertensionPrehypertensionOverweightObesityHypertrophy, Left VentricularCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCardiomegalyHeart DiseasesHypertrophyPathological Conditions, Anatomical

Study Officials

  • Tammy M Brady, M.D., Ph.D

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 14, 2015

Study Start

July 1, 2015

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

US(1)