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

This study has suspended participant recruitment.
(Lack of cooperation by the participants)
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01534091
First received: January 18, 2012
Last updated: October 6, 2013
Last verified: October 2013
  Purpose

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 Intervention
Obesity
Behavioral: Pedometer with supervision
Behavioral: Pedometer without supervision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Decline in BMI percentiles [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    BMI percentiles will be calculated at the beginning and in the end of the study


Secondary Outcome Measures:
  • Aerobic fitness [ Time Frame: 3 months intervention ] [ Designated as safety issue: No ]
    15 minutes of running or walking test


Estimated Enrollment: 150
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01534091     History of Changes
Other Study ID Numbers: MeirMc02711CTIL
Study First Received: January 18, 2012
Last Updated: October 6, 2013
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014