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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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.
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.
Objectives:
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:
Methods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent's group | Experimental | 3 months workshop of parents intervention, guided by dietician and phycologist |
|
| Parents and children group | Experimental | 3 months workshops of parents and children intervention, guided by dietician and phycologist |
|
| Control group | No Intervention | control group, no intervention, medical follow up only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parents and children group | Behavioral | 3 months workshops of parents and children intervention, guided by dietician and phycologist |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI | 24 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof, MD | Schneider Children Medical Center | Principal Investigator |
| Joseph Meyerovitch, Dr, MD | Schneider Children Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| schneider children medical center of Israel | Petah Tikva | 49202 | Israel |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Parent's group | Behavioral | 3 months workshop of parents intervention, guided by dietician and phycologist |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |