Home Exercise Intervention in Childhood Obesity

September 22, 2017 updated by: Juan F. Lisón Párraga, Dr, Cardenal Herrera University

Home Exercise Intervention in Childhood Obesity: Randomized Clinical Trial Comparing Print-based Versus Web-based Platform

Aim: To evaluate the impact of a physical exercise Web-based program with or without support on body composition, physical fitness and blood pressure values.

Design: Randomized Controlled Trial. Population: Obese children and adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent years there has been a decline in levels of physical activity (PA) in both children and adults. The promotion of PA is also a key element in the treatment of obesity, along with changing eating habits, but usually has very low levels of adherence. Active video games may be an alternative for the promotion of PA in the treatment of obesity.

The objective of this project is to evaluate the impact of a physical exercise Web-based program with or without support on Body Composition, Physical Fitness and Blood Pressure values.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46113
        • Moncada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight or obese children and adolescents

Exclusion Criteria:

  • Secondary obesity syndromes
  • Severe obesity (z score > 2.5)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Web-based intervention without support
3 months Web-based intervention without support
Other: Web-based intervention without support
Web-based combined aerobics and muscular strength exercises.
Experimental: Web-based intervention with support
3 months Web-based intervention with support (e-mails)
Other: Web-based intervention with support
Web-based combined aerobics and muscular strength exercises.
Active Comparator: Traditional intervention
3 months of Printed-based intervention
Other: Traditional intervention
3 months of Printed-based combined aerobics and muscular strength exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of body fat
Time Frame: Change from Baseline Percentage of body fat at 3 months
Percentage of body fat
Change from Baseline Percentage of body fat at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand strength
Time Frame: Change from Baseline Hand strength at 3 months
Hand strength
Change from Baseline Hand strength at 3 months
Oxygen consumption peak
Time Frame: Change from Baseline Oxygen consumption peak at 3 months
Oxygen consumption peak
Change from Baseline Oxygen consumption peak at 3 months
Blood pressure
Time Frame: Change from Baseline Blood Pressure at 3 months
Blood pressure
Change from Baseline Blood Pressure at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Investigators

  • Study Director: JF Lisón, Dr, University Ceu Cardenal Herrera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

March 5, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIVERSITY CARDENAL HERRERA-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child Obesity

Clinical Trials on Web-based intervention without support

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe