Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT03087994
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2017-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Obesity on Level of Depression and Cognitive and Executive Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-19', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological questionnaires', 'timeFrame': 'change from baseline Psychological questionnaires at 3 months and at 1 year'}, {'measure': 'Nutritional questionnaires', 'timeFrame': 'change from baseline Nutritional questionnaires at 3 months and at 1 year'}], 'secondaryOutcomes': [{'measure': 'height', 'timeFrame': 'change from baseline height at 3 months and at 1 year'}, {'measure': 'weight', 'timeFrame': 'change from baseline weight at 3 months and at 1 year'}, {'measure': 'fat mass', 'timeFrame': 'change from baseline fat mass at 3 months and at 1 year'}, {'measure': 'circumference of hips', 'timeFrame': 'change from baseline circumference of hips at 3 months and at 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The proposed study is a randomized, open, comparative research involving an intervention group and two control groups.\n\nThe 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.\n\n60 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.\n\nAnother 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adolescent girls aged 12-17, who attend the Endocrinology Institute in Schneider Hospital and comply with the research criteria: obesity (BMI above percentile 85) and appropriate weight (BMI between percentiles 5-85).\n2. Adolescent level according to Tanner: 4-5.\n3. Participants with obesity: BMI above percentile 85 for age group.\n4. Participants in control group with appropriate weight: BMI percentile 5-85 for age group.\n5. Appropriate height (Percentiles 3-97 according to the CDC curve).\n6. Parents' signature on informed consent form.\n\nExclusion Criteria:\n\n1. Chronic illness or chronic use of medications.\n2. Inability to comply with the research conditions."}, 'identificationModule': {'nctId': 'NCT03087994', 'briefTitle': 'The Influence of Obesity on Level of Depression and Cognitive and Executive Functions', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Influence of Obesity on Level of Depression and Cognitive and Executive Functions', 'orgStudyIdInfo': {'id': 'rmc027816ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'girls with obesity attending a dietary intervention', 'description': 'Participants in this group will attend 12 meetings of dietary interventions that will be guided by a dietician.', 'interventionNames': ['Behavioral: Nutritional guidance intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'girls with obesity', 'description': 'participants in this group will only receive nutrition guidance once during the study', 'interventionNames': ['Behavioral: Nutritional guidance intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'girls with normal weight', 'description': 'participants in this group will only receive nutrition guidance once during the study', 'interventionNames': ['Behavioral: Nutritional guidance intervention']}], 'interventions': [{'name': 'Nutritional guidance intervention', 'type': 'BEHAVIORAL', 'description': 'participants in this group will attend 12 meeting of nutritional guidance', 'armGroupLabels': ['girls with obesity attending a dietary intervention']}, {'name': 'Nutritional guidance intervention', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will only receive nutrition guidance once during the study', 'armGroupLabels': ['girls with normal weight', 'girls with obesity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49202', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Joseph MD Meirovitch, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schneider children Medical center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}