NCT01555034

Brief Summary

The Child health and Sports Center, Meir Medical Center, has an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment.The emphasis given in the center to physical activity and sport enables a strong connection with movement therapy. Movement therapy allows obese children to face and cope with the psychological and emotional aspects of obesity. The purpose of this study is to evaluate the contribution of the movement therapy intervention to our program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 14, 2015

Status Verified

March 1, 2014

Enrollment Period

3 years

First QC Date

March 8, 2012

Last Update Submit

April 13, 2015

Conditions

Obesity

Keywords

obesitymovement therapyexercisebehaviour

Outcome Measures

Primary Outcomes (1)

  • Emotional/behavioral changes

    Change from Baseline in emotional and behavioral questioners at 3 months. The questioners: depression, anxiety, self-efficacy, self-esteem, attachment and quality of life.

    3 MONTHS

Secondary Outcomes (1)

  • weight, height and BMI

    3 MONTHS

Study Arms (2)

intervention plus therapy

ACTIVE COMPARATOR
Behavioral: movement therapy

intervention no therapy

ACTIVE COMPARATOR

exercise and nutrition

Other: exercise plus nutrition

Interventions

movement therapyBEHAVIORAL

exercise, nutrition, movement therapy

intervention plus therapy
exercise plus nutritionOTHER

exercise, nutrition

intervention no therapy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Overweight/obese children

You may not qualify if:

  • Child that do not want to take part in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

ObesityMotor ActivityBehavior

Interventions

ExerciseNutritional Status

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Dan Nemet, 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

March 8, 2012

First Posted

March 15, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 14, 2015

Record last verified: 2014-03

Locations

IL(1)