Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial

January 11, 2012 updated by: Cardenal Herrera University
The aim of this study was to compare the effect of a hospital group-based vs. home-based combined exercise-diet program for the treatment of childhood obesity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

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
      • Moncada, Valencia, Spain, 46113
        • Universidad CEU-Cardenal Herrera

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

6 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • caucasian
  • overweight/obese

Exclusion Criteria:

  • Subjects with severe obesity (z-score above 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hospital-based exercise program
Exercise monitored at the hospital
Other: Circuit training
Aerobic and resistance training exercises + Mediterranean diet
Experimental: Home-based exercise program
Participants perform exercise at home
Other: Circuit training
Aerobic and resistance training exercises + Mediterranean diet
No Intervention: Control
Control Group participants maintained their usual levels of daily activity, with no additional exercise components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 6 months
body mass index (BMI), BMI-Z score
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
waist circumference
Time Frame: 6 months
6 months
Percentage body fat
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Cardenal Herrera University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 4, 2012

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEU-UCH-95

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.

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