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Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children

NCT00438555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2015-03-19

No results posted yet for this study

Summary

Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in al 3 groups) at months 0, 3, 12 and 24.

Conditions

Interventions

BEHAVIORAL

Parents and children group

3 months workshops of parents and children intervention, guided by dietician and phycologist

BEHAVIORAL

Parent's group

3 months workshop of parents intervention, guided by dietician and phycologist

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, Prof, MD · Schneider Children Medical Center

  • Joseph Meyerovitch, Dr, MD · Schneider Children Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00438555 on ClinicalTrials.gov