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The proposed study is a randomized, open, comparative research involving an intervention group and two control groups.
The aims of the study are: 1.To compare levels of depression in female adolescents with obesity and a control group of female adolescents with appropriate weight and height. 2. To investigate whether a decrease in weight due to a short range intervention program provided by dietician for female adolescents with obesity will lead to change in the levels of symptoms of depression and cognitive and executive functions in comparison to a control group of adolescent girls with obesity, matched in age that does not receive such an intervention program.
60 Female adolescents with obesity will be recruited to the study and will be randomized to 1 of two groups- 1. intervention group- participants in this group will attend an intervention program consisting of 12 meetings with dietician and will attend two study visits at the clinic- in the beginning of the study and after three months. 2.Control group- Participants in this group will only come to two study visits at the clinic. In the first two visits they will meet with a dietician and will receive nutrition guidance.
Another 30 girls with appropriate weight will be recruited to second control group- this group will come to two study visits at the clinic- in the beginning of the study and after three months. In the first visit participants will receive nutrition guidance by the dietician.
In the study visits the following procedures will be performed for all study groups: Blood tests, completion of psychological and nutritional questionnaires, completion of computerized tests and measurements of height, weight, fat mass and circumference of hips.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| girls with obesity attending a dietary intervention | Experimental | Participants in this group will attend 12 meetings of dietary interventions that will be guided by a dietician. |
|
| girls with obesity | Active Comparator | participants in this group will only receive nutrition guidance once during the study |
|
| girls with normal weight | Active Comparator | participants in this group will only receive nutrition guidance once during the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional guidance intervention | Behavioral | participants in this group will attend 12 meeting of nutritional guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychological questionnaires | change from baseline Psychological questionnaires at 3 months and at 1 year | |
| Nutritional questionnaires | change from baseline Nutritional questionnaires at 3 months and at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| height | change from baseline height at 3 months and at 1 year | |
| weight | change from baseline weight at 3 months and at 1 year | |
| fat mass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph MD Meirovitch, Prof. | Schneider children Medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center | 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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| Nutritional guidance intervention | Behavioral | Participants in this group will only receive nutrition guidance once during the study |
|
| change from baseline fat mass at 3 months and at 1 year |
| circumference of hips | change from baseline circumference of hips at 3 months and at 1 year |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |