Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
4055obesityprv
1 other identifier
interventional
248
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Oct 2006
Longer than P75 for not_applicable obesity
1 active site
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
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 21, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 19, 2015
July 1, 2014
8 years
February 21, 2007
March 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BMI
24 month
Study Arms (3)
Parent's group
EXPERIMENTAL3 months workshop of parents intervention, guided by dietician and phycologist
Parents and children group
EXPERIMENTAL3 months workshops of parents and children intervention, guided by dietician and phycologist
Control group
NO INTERVENTIONcontrol group, no intervention, medical follow up only
Interventions
3 months workshops of parents and children intervention, guided by dietician and phycologist
3 months workshop of parents intervention, guided by dietician and phycologist
Eligibility Criteria
You may qualify if:
- Children aged 5-10 years old
- BMI in 85-98 percentile
- Both parents signing informed consent form
You may not qualify if:
- Chronic disease or chronic use of medication
- Incapability to perform all study procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Pfizercollaborator
Study Sites (1)
schneider children medical center of Israel
Petah Tikva, 49202, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moshe Phillip, Prof, MD
Schneider Children Medical Center
- PRINCIPAL INVESTIGATOR
Joseph Meyerovitch, Dr, MD
Schneider Children Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2007
First Posted
February 22, 2007
Study Start
October 1, 2006
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
March 19, 2015
Record last verified: 2014-07