NCT01285063

Brief Summary

The goal of the this study is to create an interdisciplinary program which includes intervention in the fields of nutrition, physical activity and behavior in order to treat obesity and overweight among kindergarten children and to examine the influence of such program on the BMI,BMI%, physical fitness, knowledge and preferences in the said fields among the participants.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 7, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

December 7, 2010

Last Update Submit

February 20, 2013

Conditions

Keywords

overweightobesityphysical fitnesskinder gardenpreschool

Outcome Measures

Primary Outcomes (1)

  • reduction of the BMI percentage among the participants in comparison to the control group.

    height, weight, BMI and BMI percentage will be documented after each meeting with the dietitian.

    every 2 weeks.

Secondary Outcomes (2)

  • Improvement in the physical fitness of the participants in comparison to the control group.

    Day 1 and after 3 months.

  • Positive change in the knowledge and preferences of the participants in the fields of nutrition and physical activity in comparison to the control group.

    Day 1 and after 3 months.

Study Arms (1)

physical activiy & nutrition

EXPERIMENTAL

25 kindergarten children in the ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95). Non-generalization criteria: children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.

Other: Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.

Interventions

3 months intervention. Nutritious plan: includes 6 meetings of the child and his or her parents with a dietician from the center. Physical activity: physical trainings of 60 minutes each will be held twice a week. behavioral treatment: all the participants will take part it a 45 minutes meeting of movement therapy once a week. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle.

physical activiy & nutrition

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children in ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95).

You may not qualify if:

  • children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the sports and health center for children and youth at "Meir" medical center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tali Sinai, Dr

    The hebrew university, Jerusalem

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2010

First Posted

January 27, 2011

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations