Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time

April 13, 2015 updated by: Meir Medical Center

The purpose of this study is to examine if internet supervised by pedometer will contribute to enhance the amount of physical activity at leisure time by obese children.

The investigators hypothesize that using pedometer will increase the amount of physical activity done by obese children in the afternoon and will improve the likelihood of success in the intervention program.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Childhood overweight & obesity is the most common chronic disease in the western society. The prevalence of childhood obesity in Israel is among the highest in Europe. Recent data suggest that the recommended treatment for childhood obesity should be intense, multi-disciplinary intervention, including dietary, behavioral and physical activity components. Such a program exists at the Meir Medical Center in Israel for a few years with promising results.

The program includes: physical activity(PA)exercise (twice a week/1h), dietary guidance, medical supervision and behavioral intervention. The participants are asked to enhance PA at their leisure time, and to report to their coaches. Yet, the amount of time they actually exercise is not controled by us.

This study will include 3 groups of overweight& obese children:

  1. Intervention with pedometers and supervision.
  2. Intervention with pedometer without supervision.
  3. Control. Obese and overweight children not taking part in a treatment program.

Study Type

Interventional

Enrollment (Actual)

25

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

  • Israel
      • Kfar-Saba, Israel
        • Meir Medical Center

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

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • overweight/obese children
  • age 5-18
  • boys and girls

Exclusion Criteria:

  • children with genetic obesity or obesity cased by a disease

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pedometer with supervision
Participants will get pedometers to evaluate their daily PA. The sport center stuff will review the child weekly reports, guide the child, encourage him and supervise that the recommended PA level is achieved.
Behavioral: Pedometer with supervision
Other Names:
  • exercise + diet + pedometer
Active Comparator: Pedometer without supervision
Participants will get pedometers to evaluate their daily PA. The sport center stuff won't give any recommendation or supervision for PA level.
Behavioral: Pedometer without supervision
Other Names:
  • exercise + diet + closed pedometer
No Intervention: Control group
Overweight & obese children not participating in an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decline in BMI percentiles
Time Frame: 3 months
BMI percentiles will be calculated at the beginning and in the end of the study
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic fitness
Time Frame: 3 months intervention
15 minutes of running or walking test
3 months intervention

Collaborators and Investigators

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

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Dan Nemet, Prof. MD, Meir Medical Center

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

May 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

February 15, 2012

First Posted (Estimate)

February 16, 2012

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MeirMc02711CTIL

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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