Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-03-03 @ 10:17 AM
Study NCT ID:
NCT02464566
Status:
UNKNOWN
Last Update Posted:
2015-06-08
First Post:
2015-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Jeddah 2015
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2015-06-01', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Reduction', 'timeFrame': '1-12 weeks'}], 'secondaryOutcomes': [{'measure': 'Waist circumference changes', 'timeFrame': '1-12 weeks'}, {'measure': 'Hip circumference changes', 'timeFrame': '1-12 weeks'}, {'measure': 'Systolic and Diastolic Blood pressure changes', 'timeFrame': '1-12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'With low carbohydrate dietary approach for both arms, the investigators will examine the effectiveness of 12-weeks intensive lifestyle intervention program provided in individual sessions in primary health care obesity clinic in Jeddah with aim to achieve 5% reduction of baseline weight for experimental participants in comparison with active comparator group (only one health education session).', 'detailedDescription': 'The study has two arms:\n\nActive Comparator Arm:\n\nOnly health education. One session regarding diet restriction and physical activity with printed health education papers.\n\nExperimental Arm:\n\nIntensive lifestyle intervention Weekly individual session in obesity clinic (15 to 20 min.) for the first 4 weeks then one individual session in obesity clinic (10 to 20 min.) every two weeks (week 5 to week 12).\n\nTotal sessions in 12 weeks: 8 (including the final data collection visit).The components of the program: 1) Low carbohydrate (aim to achieve spontaneous reduction in calorie intake) 2) increased physical activity; 3) behavioral strategies to facilitate adherence to diet and activity prescriptions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 20 years old or older\n* Arabic Male or female\n* Body mass index in kg/m2 (BMI) ≥30\n\nExclusion Criteria:\n\n* Had recent weight loss equal or more than 5% of baseline weight\n* Currently take weight loss medication or enrolled in another weight loss program\n* Undergone or scheduled (within study duration) weight loss surgery\n* History of diabetes, thyroid dysfunction or any other endocrine abnormality, gout, coronary heart disease, stroke, malignancy or psychological condition\n* Medical condition that limits ability to comply with the program's physical activity recommendations\n* Pregnant or lactating women\n* If one participant had recruited in the study, his family members who live with him in the same home will be ineligible (to avoid contamination from the ripple effect on weight loss)"}, 'identificationModule': {'nctId': 'NCT02464566', 'briefTitle': '12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Jeddah 2015', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Saudi Commission for Health Specialties, Saudi Arabia'}, 'officialTitle': '12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Randomized Control Trial, Jeddah 2015', 'orgStudyIdInfo': {'id': 'SaudiCHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L Group', 'description': 'Weekly individual session in obesity clinic (15 to 20 min.) for the first 4 weeks then one individual session in obesity clinic (10 to 20 min.) every two weeks (week 5 to week 12).\n\nTotal sessions in 12 weeks: 8 (including the final data collection visit). The components of the program:\n\n1\\) Low carbohydrate (aim to achieve spontaneous reduction in calorie intake) 2) increased physical activity; 3) behavioural strategies to facilitate adherence to diet and activity prescriptions.', 'interventionNames': ['Behavioral: Intensive lifestyle intervention', 'Other: Health Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C Group', 'description': 'One session regarding diet restriction and physical activity with printed health education papers.', 'interventionNames': ['Other: Health Education']}], 'interventions': [{'name': 'Intensive lifestyle intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['L Group']}, {'name': 'Health Education', 'type': 'OTHER', 'armGroupLabels': ['C Group', 'L Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saudi Commission for Health Specialties, Saudi Arabia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Riyad Q. Alghamdi', 'investigatorAffiliation': 'Saudi Commission for Health Specialties, Saudi Arabia'}}}}