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

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pedometer with supervision
Pedometer without supervision
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring overweight, obese, children, exercise, physical activity, pedometer

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • children with genetic obesity or obesity cased by a disease

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Pedometer with supervision

Pedometer without supervision

Control group

Arm Description

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.

Participants will get pedometers to evaluate their daily PA. The sport center stuff won't give any recommendation or supervision for PA level.

Overweight & obese children not participating in an intervention.

Outcomes

Primary Outcome Measures

Decline in BMI percentiles
BMI percentiles will be calculated at the beginning and in the end of the study

Secondary Outcome Measures

Aerobic fitness
15 minutes of running or walking test

Full Information

First Posted
January 18, 2012
Last Updated
April 13, 2015
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01534091
Brief Title
Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time
Official Title
Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of cooperation by the participants
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
overweight, obese, children, exercise, physical activity, pedometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pedometer with supervision
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pedometer without supervision
Arm Type
Active Comparator
Arm Description
Participants will get pedometers to evaluate their daily PA. The sport center stuff won't give any recommendation or supervision for PA level.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Overweight & obese children not participating in an intervention.
Intervention Type
Behavioral
Intervention Name(s)
Pedometer with supervision
Other Intervention Name(s)
exercise + diet + pedometer
Intervention Type
Behavioral
Intervention Name(s)
Pedometer without supervision
Other Intervention Name(s)
exercise + diet + closed pedometer
Primary Outcome Measure Information:
Title
Decline in BMI percentiles
Description
BMI percentiles will be calculated at the beginning and in the end of the study
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Aerobic fitness
Description
15 minutes of running or walking test
Time Frame
3 months intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: overweight/obese children age 5-18 boys and girls Exclusion Criteria: children with genetic obesity or obesity cased by a disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, Prof. MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar-Saba
Country
Israel

12. IPD Sharing Statement

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

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