Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children (4055obesityprv)
This study is currently recruiting participants.
Verified December 2012 by Rabin Medical Center
Sponsor:
Rabin Medical Center
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00438555
First received: February 21, 2007
Last updated: January 1, 2013
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Parents and children group Behavioral: Parent's group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children |
Resource links provided by NLM:
Further study details as provided by Rabin Medical Center:
Primary Outcome Measures:
- BMI [ Time Frame: 24 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 270 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Parent's group
3 months workshop of parents intervention, guided by dietician and phycologist
|
Behavioral: Parent's group
3 months workshop of parents intervention, guided by dietician and phycologist
|
|
Experimental: Parents and children group
3 months workshops of parents and children intervention, guided by dietician and phycologist
|
Behavioral: Parents and children group
3 months workshops of parents and children intervention, guided by dietician and phycologist
|
|
No Intervention: Control group
control group, no intervention, medical follow up only
|
Detailed Description:
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.
Objectives:
- To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
- To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
- To evaluate the role and significance of including parents in an intervention program for obesity prevention.
- 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:
- parent's group- only parents will take part at the intervention program.
- Parents and children group- both children and parents will take part at the intervention program, in two separate sessions.
Methods:
- 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.
- 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.
- Physical examination will be performed at 0, 3, 12 and 24 month.
- Psychological and nutritional questionnaire (depression, quality of life and self estimation) will be filled at 0, 3, 12 and 24 month.
- Fasting blood tests for: chemistry, hematology, lipids, glucose, insulin, TSH, adiponectin, IL-6 and TNFα will be performed at 0, 3, 12 and 24 month.
Eligibility| Ages Eligible for Study: | 5 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438555
Contacts
| Contact: Moshe Phillip, Prof, MD | 972-3-9253778 ext direct | mosheph@clalit.org.il |
| Contact: Joseph Meyerovitch, Prof, MD | 972-3-6923478 ext direct | josephm@clalit.org.il |
Locations
| Israel | |
| schneider children medical center of Israel | Recruiting |
| Petach Tikva, Israel, 49202 | |
| Principal Investigator: Moshe Phillip, MD, Prof | |
| Principal Investigator: Joseph Meyerovitch, MD | |
| Sub-Investigator: Revital Nimri, MD | |
| Sub-Investigator: Shlomit Shalitin, MD | |
| Sub-Investigator: Liat de Vries, MD | |
| Sub-Investigator: Yael Lebenthal, MD | |
Sponsors and Collaborators
Rabin Medical Center
Pfizer
Investigators
| Principal Investigator: | Moshe Phillip, Prof, MD | Schneider Children Medical Center |
| Principal Investigator: | Joseph Meyerovitch, Dr, MD | Schneider Children Medical Center |
More Information
No publications provided
| Responsible Party: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00438555 History of Changes |
| Other Study ID Numbers: | rmc004055ctil |
| Study First Received: | February 21, 2007 |
| Last Updated: | January 1, 2013 |
| Health Authority: | Israel:Clalit Health Services |
Keywords provided by Rabin Medical Center:
|
obesity,prevention,pediatric |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013