Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-10 @ 1:13 PM
Study NCT ID:
NCT03821220
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072936', 'term': 'Fitness Trackers'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 375}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-03', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-01-27', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity level assessed through average weekly steps', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'Fasting glucose levels', 'timeFrame': 'six months'}, {'measure': 'HbA1C levels', 'timeFrame': 'six months'}, {'measure': 'Body Mass Index', 'timeFrame': 'six months'}, {'measure': 'Lipid profile', 'timeFrame': 'six months'}, {'measure': 'Blood pressure', 'timeFrame': 'six months'}, {'measure': 'Energy intake 500< kcal/d <6000 kcal/d', 'timeFrame': 'Six months'}, {'measure': 'Waist circumference', 'timeFrame': 'six months'}, {'measure': 'Fat intake 15 <gram/day<200', 'timeFrame': 'six months'}, {'measure': 'Protein intake 10<gram/day<300', 'timeFrame': 'six months'}, {'measure': 'Iron intake 0<mg/day<50', 'timeFrame': 'six months'}, {'measure': 'Folic acid intake 15< μg/day<3000', 'timeFrame': 'six months'}, {'measure': 'Vitamin A intake 20< μg RAE/day<2500', 'timeFrame': 'six months'}, {'measure': 'Vitamin C intake 0<mg/day<2500', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Activity tracker; Arab population; Physical Activity'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This three-arm clinical trial aims to improve levels of physical activity among Arabic- speaking residents of East Jerusalem with prediabetes. Levels of daily physical activity (assessed through activity trackers), dietary habits and self-assessed health will be compared between patients that receive only the activity tracker and written information (group A), receive the activity tracker, written information and a personalized physical activity prescription (group B), and those that receive in addition also intensive follow-up with motivational interview by physician assistants and a dietitian (group C)', 'detailedDescription': 'This is a three-arm clinical trial studying the effect of providing activity trackers with intensive motivational interview by trained physician assistants, and dietitian counselling, on the levels of daily physical activity among Arabic- speaking residents of East Jerusalem with prediabetes from Clalit Health Services. In addition, this study will also assess healthy dietary changes, and self assessed health and quality of life.\n\nThe study will compare three groups (total 375, each group 125):\n\nGroup A - will receive activity trackers and written educational handouts in addition to their usual care.\n\nGroup B - will receive all of group A intervention components and also a personalized physical activity prescription.\n\nGroup C - will receive all of group B components and also intensive motivational interview support by trained physician assistants (3 sessions), and dietitian support (two sessions).\n\nEach participant will be followed-up for six months, with data collection occurring at baseline, three months and six months. Data collection will include average weekly steps, blood pressure, anthropometric measurements, routine blood tests (including fasting glucose, HbA1C, and lipid profile), physical activity survey, Mediterranean dietary habits survey, Food Frequency Questionnaire, and quality of life survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPre-diabetes patients - Impaired fasting glucose at least twice between 100-125 mg/dL in the two years prior to the study; or HbA1C 5.7%-6.4% twice in the two years prior to the study; or one test of fasting glucose of 100-125 mg/dL, and one test of HbA1C between 5.7%-6.4% in the two years prior to the study.\n\nExclusion Criteria:\n\n1. Diabetes including a doctor's diagnosis based on a medical file or a recurrence of fasting blood glucose values above 126 mg/dL in the year preceding the study or a glucose value greater than 200 mg/dL in the year prior to the study or HbA1C above 6.5%\n2. Treatment with diabetes drugs other than metformin, as prescribed in the medical file with regular or chronic medications\n3. Artificial lower limbs or inability to walk normally (eg: stroke with plegia)\n4. Chronic obstructive pulmonary disease\n5. Known heart disease (with impaired exercise tolerance)\n6. Pregnancy\n7. Medical conditions:\n\n * a cardiac event/ Transient ischemic attack in the last year\n * Cerebrovascular attack with residual impairment\n * Surgery that required hospitalization in the last year\n * Injury to lower limbs that prevents regular walking\n * Malignancy excluding skin cancer small cell carcinoma or basal cell carcinoma"}, 'identificationModule': {'nctId': 'NCT03821220', 'briefTitle': 'Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes', 'orgStudyIdInfo': {'id': '0201-17-COM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care.', 'interventionNames': ['Behavioral: Activity tracker plus usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Patients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care.', 'interventionNames': ['Behavioral: Activity tracker plus usual care', 'Behavioral: Personalized physical activity prescription']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Patients will receive an activity tracker, written information for pre-diabetic, personalized physical activity prescription, three sessions of motivational interview support from trained physician assistants, and two session of dietitian support, on top of their usual care.', 'interventionNames': ['Behavioral: Motivational Interview support and Dietitian support', 'Behavioral: Activity tracker plus usual care', 'Behavioral: Personalized physical activity prescription']}], 'interventions': [{'name': 'Motivational Interview support and Dietitian support', 'type': 'BEHAVIORAL', 'description': 'Three sessions of a structured motivational support intervention. Each patient will be required to set a SMART physical activity personal objective. The sessions will cover possible barriers and facilitators, enhancing self-efficacy, and feedback. In addition two sessions with a dietitian to discuss ways to improve current health habits.', 'armGroupLabels': ['Group C']}, {'name': 'Activity tracker plus usual care', 'type': 'BEHAVIORAL', 'description': 'Each patient will receive their own activity tracker (vivofit 3) with instructions on use, in addition to usual care, and written handouts for pre-diabetic patients.', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Personalized physical activity prescription', 'type': 'BEHAVIORAL', 'description': 'Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.', 'armGroupLabels': ['Group B', 'Group C']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amnon Lahad, MD', 'role': 'CONTACT', 'email': 'amnonl@ekmd.huji.ac.il', 'phone': '972-52-3293484'}], 'overallOfficials': [{'name': 'Amnon Lahad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clalit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Medical Quality unit and Chairman department of Family Medicine, Clalit Health Services, Jerusalem district', 'investigatorFullName': 'Prof. Amnon Lahad', 'investigatorAffiliation': 'Clalit Health Services'}}}}