Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT06017856
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of functional gastrointestinal disorder', 'timeFrame': '6 months', 'description': 'The number of participants with a diagnosis of functional gastrointestinal disorder according to the Rome IV criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obese', 'overweight', 'abdominal pain', 'diarrhea'], 'conditions': ['Functional Gastrointestinal Disorders', 'Obesity, Childhood']}, 'descriptionModule': {'briefSummary': 'A prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.', 'detailedDescription': 'The investigators intend to conduct a prospective observational case-control study of overweight and obese children, aged 6-18 years, followed in the child health and sport center at Meir medical center, Kfar-Saba, Israel.\n\nOverweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, will be offered to participate. Healthy subjects with normal BMI percentile from other pediatric outpatient clinics as well as relatives and friends of physicians from the pediatric division will be enrolled and serve as the control group.\n\nStudy visits will be at enrollment and after 3 and 6 months of participation in the intervention program. During the visits the investigators will collect anthropometric measurements (height, weight, BMI, total body fat). Participants (age 10y and above) or their parents (age 6-10y) will fill a validated questionnaire for diagnosis of FGID based on ROME IV criteria. The investigators will also collect data from exercise capability testing and quality of life questionnaires performed regularly (and irrespective of this study) during the intervention program.\n\nThe investigators will then compare between subjects who succeeded to those who failed in losing at least 5% of their initial body weight as well as to healthy controls with normal BMI percentile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'obese and overweight subjects patricipating in the life style modification program as well as healhy controls of normal weight', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese / overweight children participating in the life style modification program at the child sport and health center\n\nExclusion Criteria:\n\n* other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease, inflammatory bowel disease)'}, 'identificationModule': {'nctId': 'NCT06017856', 'briefTitle': 'Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Impact of Physical Exercise and Nutrition on Functional Gastrointestinal Disorders in Obese Children', 'orgStudyIdInfo': {'id': 'MMC-22-0199'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'obese and overweight', 'description': 'Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, participating the in life-style intervention program in the child sport center at Meir medical center', 'interventionNames': ['Other: Life style intervention program']}, {'label': 'normal weight', 'description': 'normal weight subjects defined as body mass index (BMI) percentile \\<85%, with no other chronic conditions'}], 'interventions': [{'name': 'Life style intervention program', 'type': 'OTHER', 'description': 'Life style intervention program for the obese/overweight subjects conducted regardless of this study at the child sport and health center at Meir medical center', 'armGroupLabels': ['obese and overweight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4464402', 'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Eyal Zifman, MD', 'role': 'CONTACT', 'email': 'eyalzi@clalit.org.il', 'phone': '+97297471596'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Eyal Zifman, MD', 'role': 'CONTACT', 'email': 'eyalzi@clalit.org.il', 'phone': '+97297471596'}], 'overallOfficials': [{'name': 'Eyal Zifman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of pediatric gastroeneterogy service', 'investigatorFullName': 'eyal zifman', 'investigatorAffiliation': 'Meir Medical Center'}}}}