Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-04 @ 4:55 AM
Study NCT ID:
NCT01991002
Status:
UNKNOWN
Last Update Posted:
2013-11-26
First Post:
2013-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
14/21 Diet-walking in the Park
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-24', 'studyFirstSubmitDate': '2013-10-21', 'studyFirstSubmitQcDate': '2013-11-17', 'lastUpdatePostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biochemical markers', 'timeFrame': '2 years', 'description': 'To measure glucose, HbA1C (Glycated hemoglobin), blood fat profile, liver enzymes, inflammatory markers.'}, {'measure': 'Blood pressure', 'timeFrame': '2 years', 'description': 'Blood pressure will be measured.'}, {'measure': 'Quality of life.', 'timeFrame': '2 years', 'description': 'Visual Analog Scale questionnaire and SF-12 questionnaire will be filled out by the subjects.'}], 'primaryOutcomes': [{'measure': 'Weight reduction', 'timeFrame': '2 years', 'description': 'BMI will be calculated by the equation weight divided by square height.'}], 'secondaryOutcomes': [{'measure': 'Anthropometric measurements', 'timeFrame': '2 years', 'description': 'Waist circumference will be measured at the level of the umbilicus. Hip circumference will be measured at the widest portion of the buttocks. Waist/hip ratio will be calculated. "Tanita" will be used for body composition analysis (%fat mass, fat mass,fat free mass and RMR).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['14/21 diet', 'BMI', 'biochemical blood markers', 'quality of life'], 'conditions': ['Overweight: 25 <BMI <30']}, 'descriptionModule': {'briefSummary': 'The scientific literature shows a quantitative relationship between diet combined with physical activity as a long term weight reduction modality and an important factor in weight maintenance.\n\nPrimary assumption - the 14/21 diet will have an impact on BMI values, and their long-term maintenance.\n\nSecondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.', 'detailedDescription': 'An interventional part for a duration of 56 days and a follow-up period including monitoring of different parameters. Follow up session are set to 3, 6, 12 and 24 months from the end of the interventional period.\n\nParticipants will be recruited in several rounds, each including up to 25 participants. Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days.\n\nThe diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.During the intervention period subjects will meet for walking. In addition, 30 minutes of aerobic exercise will be recommended 3 times/week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHebrew speaking 25\\<BMI\\<30 18 years old or older signed an informed consent\n\nExclusion Criteria:\n\nSubjects who have a physical disability preventing them from exercise, Subjects who are pregnant or lactating, Subjects who are currently involved in another lifestyle intervention program, Subjects who had undergone bariatric surgery in the past, Subjects with: cancer, liver/kidney disease, organ transplantation, alcohol/drug addiction, Subjects that have cognitive deterioration or psychosis, vegetarians who does't eat fish/sea food or vegans\n\n\\-"}, 'identificationModule': {'nctId': 'NCT01991002', 'briefTitle': '14/21 Diet-walking in the Park', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Hospital Systems'}, 'officialTitle': 'Prospective Interventional Study of the Impact of 3-step Diet With Complimentary Exercise Program', 'orgStudyIdInfo': {'id': 'diet003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '14/21 diet', 'description': 'Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days.\n\nThe diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.', 'interventionNames': ['Behavioral: 14/21 diet']}], 'interventions': [{'name': '14/21 diet', 'type': 'BEHAVIORAL', 'description': 'Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days.\n\nThe diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.', 'armGroupLabels': ['14/21 diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Assuta medical centers', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Joshua Shemer, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuta Hospital Systems'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Hospital Systems', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chairman of the board', 'investigatorFullName': 'Prof. Sh.Shemer', 'investigatorAffiliation': 'Assuta Hospital Systems'}}}}