NCT01578863

Brief Summary

The child health and sports center, at the Meir Medical Center, runs for over 10 years an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment. A similar program exists in the nearby city of Hadera. The aim of the programs is to promote weight loss, encourage physical activity and modify behavior in order to get long term results. The aim of the present study is to try and identify the demographic and behavioral characteristics of children who succeed in the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

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 15, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.8 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

May 1, 2014

Enrollment Period

2.8 years

First QC Date

March 15, 2012

Last Update Submit

April 13, 2015

Conditions

Keywords

Childhood obesityAdolescencePredictorsSuccessIntervention program

Outcome Measures

Primary Outcomes (1)

  • Characteristics of the children who succeed in the program

    We will use behavioral, emotional, physical, familial and demographic questionnaires to characterize the children taking part in the programs. The questionnaires: self-efficacy, motivation, depression, parenting style, demographic, environmental.Anthropometric and fitness measurements are performed on a monthly basis .

    6 Months

Study Arms (3)

Intervention program

ACTIVE COMPARATOR

6 months intervention program to lose weight in obese children. Behavioral, emotional, physical, familial and demographic questioners will be fulfilled at the beginning and at the end of the program.

Other: Intervention program for obese children

Untreated obese children

NO INTERVENTION

Behavioral, emotional, physical, familial and demographic questioners will be fulfilled twice in a 6 month program.

Normal weight children

NO INTERVENTION

Behavioral, emotional, physical, familial and demographic questioners will fulfill twice in the 6 month period.

Interventions

The program includes physical activity, nutrition intervention and behavioral treatment and lasts for 6 months. The aim of the program is to promote weight loss and physical activity and to promote future healthy lifestyle.

Also known as: exercise, nutrition, behavioral
Intervention program

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Obese / overweight children

You may not qualify if:

  • Children that has an organic illness that cause obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

ExerciseNutritional Status

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition 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 15, 2012

First Posted

April 17, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 14, 2015

Record last verified: 2014-05

Locations