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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01534091
• Other study ID #: MeirMc02711CTIL
• Status: Terminated
• Phase: N/A
• First received: January 18, 2012
• Last updated: April 13, 2015
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• overweight/obese children

• age 5-18

• boys and girls

Exclusion Criteria:

• children with genetic obesity or obesity cased by a disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Pedometer with supervision

• Pedometer without supervision

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decline in BMI percentiles	BMI percentiles will be calculated at the beginning and in the end of the study	3 months	No
Secondary	Aerobic fitness	15 minutes of running or walking test	3 months intervention	No