Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-01-07 @ 9:23 PM
Study NCT ID:
NCT04264793
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2020-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skills for Change: Nutrition Education Program for Emirati Adults With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster Randomized Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2013-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-08', 'studyFirstSubmitDate': '2020-02-08', 'studyFirstSubmitQcDate': '2020-02-08', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change in Total Cholesterol, LDL, HDL and Triglycerides', 'timeFrame': '12 months'}, {'measure': 'Change in Dietary Intake (Total Calories, Saturated Fat, Cholesterol, Dietary Fiber and Sodium)', 'timeFrame': '12 months', 'description': 'Dietary intake was assessed using 24 hour recall with USDA Multiple Pass Method'}, {'measure': 'Change in Physical Activity (total METs and total duration)', 'timeFrame': '12 months', 'description': 'Physical Activity was assessed using International Physical Activity Questionnaire Short Form.'}, {'measure': 'Change in Sitting time (minutes)', 'timeFrame': '12 months', 'description': 'Sitting time was assessed using International Physical Activity Questionnaire Short Form.'}, {'measure': 'Change in Weight', 'timeFrame': '12 months'}, {'measure': 'Change in BMI', 'timeFrame': '12 months'}, {'measure': 'Change in Nutrition Knowledge', 'timeFrame': '12 months', 'description': 'Questionnaire was used to assess knowledge of food sources of carbohydrates and dietary fiber'}, {'measure': 'Change in Diabetes Treatment Satisfaction Score', 'timeFrame': '12 months', 'description': 'Diabetes Treatment Satisfaction Questionnaire (Bradley,C) was used'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emirati Adults', 'United Arab Emirates', 'Lifestyle Intervention', 'Type 2 Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38820345', 'type': 'DERIVED', 'citation': 'Ali HI, Al Ketbi LB, Platat C, Abdl El Baki H, Elmi F, Ibrahim W, Zoubeidi T, Al Dhaheri AS, Cheikh Ismail L, Tariq MNM, Souka U, Yasin J, Stojanovska L. Impact of Skills for Change Program on metabolic control, diet and physical activity levels in adults with type 2 diabetes: A cluster randomized trial. PLoS One. 2024 May 31;19(5):e0304639. doi: 10.1371/journal.pone.0304639. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The "Skills for Change" Diabetes Nutrition Education Program was a one-year, community-based conducted in Ambulatory Health Care Services health centers in Al Ain. The project involved nutrition education to improve blood glucose control, diet and physical activity levels of Emirati adults with type 2 diabetes.', 'detailedDescription': 'Despite the high prevalence of diabetes and its complications in the UAE, very few diabetes education intervention studies have been conducted in a representative population in the country. The Skills for Change Program was a one-year, community-based, cluster randomized study involving Emirati adults with type 2 diabetes. We implemented a behavioral lifestyle intervention to improve glycemic control, food choices, and physical activity levels and to decrease sedentarity. The project was culturally adapted to Emirati adults with type 2 diabetes and was driven by theoretical principles of behavior change and education to enhance intervention effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* United Arab Emirates national\n* Type 2 diabetes\n* Adults: Male and female\n* Age: 20-70 years\n* Attending one of the 7 health centers in Al Ain managed by the Ambulatory Healthcare Services.\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Age \\>70 Years\n* Medical conditions that prevent active participation in the program, based on recommendation of the attending physicians\n* Participating in other nutrition intervention programs'}, 'identificationModule': {'nctId': 'NCT04264793', 'briefTitle': 'Skills for Change: Nutrition Education Program for Emirati Adults With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'United Arab Emirates University'}, 'officialTitle': 'Skills for Change: Implementation of a Community-based Diabetes Nutrition Education Program for Emirati Adults With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '10/48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Behavioral Lifestyle Intervention (3 health centers): In addition to usual care in the health center, the intervention included individual counseling and group education on nutrition and physical activity.', 'interventionNames': ['Behavioral: Behavioral Lifestyle Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control (4 health centers): Patients received usual care including education as part of the diabetes management from their healthcare professionals (physicians and nurses), normally every 2-3 months. Visits with the health center dietitian were arranged as per physician referral.', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Behavioral Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'In addition to usual care in the health center, the intervention included 7 visits with the health center dietitian for individual nutrition counseling, invitation for group nutrition education (5 sessions), individual counseling for physical activity, invitation for a 6-weekly structured group physical activity, DVD on physical activity to perform physical activity at home.', 'armGroupLabels': ['Intervention']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Patients received usual care including education as part of the diabetes management from their healthcare professionals (physicians and nurses), normally every 2-3 months. Visits with the health center dietitian were arranged as per physician referral.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Ain City', 'country': 'United Arab Emirates', 'facility': 'Ambulatory Healthcare Services, SEHA', 'geoPoint': {'lat': 24.19167, 'lon': 55.76056}}], 'overallOfficials': [{'name': 'Habiba I. Ali, PhD, RD,CDE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United Arab Emirates University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Arab Emirates University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ambulatory Healthcare Services, Al Ain, UAE', 'class': 'UNKNOWN'}, {'name': 'Sheikh Hamdan bin Rashid Al Maktoum Award for Medical Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Habiba I. Ali', 'investigatorAffiliation': 'United Arab Emirates University'}}}}