NCT01534091

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 14, 2015

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

January 18, 2012

Last Update Submit

April 13, 2015

Conditions

Keywords

overweightobesechildrenexercisephysical activitypedometer

Outcome Measures

Primary Outcomes (1)

  • Decline in BMI percentiles

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

    3 months

Secondary Outcomes (1)

  • Aerobic fitness

    3 months intervention

Study Arms (3)

Pedometer with supervision

ACTIVE COMPARATOR

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

Pedometer without supervision

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Overweight \& obese children not participating in an intervention.

Interventions

Also known as: exercise + diet + pedometer
Pedometer with supervision
Also known as: exercise + diet + closed pedometer
Pedometer without supervision

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • children with genetic obesity or obesity cased by a disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Interventions

Organization and AdministrationExerciseDiet

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health Services AdministrationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Dan Nemet, Prof. MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

February 16, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

April 14, 2015

Record last verified: 2013-10

Locations