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

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ClinicalTrials.gov Identifier: NCT01534091
Recruitment Status : Terminated (Lack of cooperation by the participants)
First Posted : February 16, 2012
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment
Obesity Behavioral: Pedometer with supervision Behavioral: Pedometer without supervision

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  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time
Study Start Date : May 2012
Primary Completion Date : November 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: exercise + diet + closed pedometer
No Intervention: Control group
Overweight & obese children not participating in an intervention.



Primary Outcome Measures :
  1. Decline in BMI percentiles [ Time Frame: 3 months ]
    BMI percentiles will be calculated at the beginning and in the end of the study


Secondary Outcome Measures :
  1. Aerobic fitness [ Time Frame: 3 months intervention ]
    15 minutes of running or walking test



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • children with genetic obesity or obesity cased by a disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534091


Locations
Israel
Meir Medical Center
Kfar-Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Dan Nemet, Prof. MD Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01534091     History of Changes
Other Study ID Numbers: MeirMc02711CTIL
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: October 2013

Keywords provided by Meir Medical Center:
overweight
obese
children
exercise
physical activity
pedometer

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms