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

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NCT00438555

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Study Location
schneider children medical center of Israel
Petach Tikva, , 49202, Israel
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
5-10 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children aged 5-10 years old

- BMI in 85-98 percentile

- Both parents signing informed consent form

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Chronic disease or chronic use of medication


- Incapability to perform all study procedure

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Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
Official Title  ICMJE Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
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.
Detailed Description

Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.

Objectives:

  1. To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
  2. To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
  3. To evaluate the role and significance of including parents in an intervention program for obesity prevention.
  4. To identify demographic parameters, lifestyle characteristic and biochemical markers that predict the risk of developing obesity and the response for treatment.

Randomization:

Patients will be randomly allocated into one of two intervention groups or control group in ratio of 1:1:1. Each group will contain 12-15 participants.

Intervention groups:

  1. parent's group- only parents will take part at the intervention program.
  2. Parents and children group- both children and parents will take part at the intervention program, in two separate sessions.

Methods:

  1. The study will be 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 all 3 groups) at months 0, 3, 12 and 24.
  2. Height, weight, fat mass and waist circumference will be measured at 0, 3, 12 and 24 month. Height and weight of parents will also be measured at these visits.
  3. Physical examination will be performed at 0, 3, 12 and 24 month.
  4. Psychological and nutritional questionnaire (depression, quality of life and self estimation) will be filled at 0, 3, 12 and 24 month.
  5. Fasting blood tests for: chemistry, hematology, lipids, glucose, insulin, TSH, adiponectin, IL-6 and TNF? will be performed at 0, 3, 12 and 24 month.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Parent's group
    3 months workshop of parents intervention, guided by dietician and phycologist
    Intervention: Behavioral: Parent's group
  • Experimental: Parents and children group
    3 months workshops of parents and children intervention, guided by dietician and phycologist
    Intervention: Behavioral: Parents and children group
  • No Intervention: Control group
    control group, no intervention, medical follow up only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2015)		248
Original Enrollment  ICMJE
 (submitted: February 21, 2007)		270
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children aged 5-10 years old
  • BMI in 85-98 percentile
  • Both parents signing informed consent form

Exclusion Criteria:

  • Chronic disease or chronic use of medication
  • Incapability to perform all study procedure
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 5 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00438555
Other Study ID Numbers  ICMJE rmc004055ctil
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Moshe Phillip, Prof, MDSchneider Children Medical Center
Principal Investigator:Joseph Meyerovitch, Dr, MDSchneider Children Medical Center
PRS Account Rabin Medical Center
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP