Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
Study NCT ID:
NCT04281069
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2019-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Type 2 in the Eastern Region of Morocco
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], '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'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001522', 'term': 'Behavior, Animal'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 821}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2019-02-15', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'systolic and diastolic blood pressure', 'timeFrame': 'first year', 'description': 'common systolic and diastolic assessment of blood pressure'}], 'primaryOutcomes': [{'measure': 'glycaemia', 'timeFrame': 'first year', 'description': 'the concentration of glucose in the blood'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': 'first year', 'description': 'The concentration of hemoglobin A1c in the blood shows the average level of blood sugar over the past 2 to 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus type 2', 'quality of life', 'interdisciplinary care'], 'conditions': ['Quality of Life', 'Diabetes Mellitus, Type 2', 'Adherence, Medication', 'Diet Habit']}, 'referencesModule': {'references': [{'pmid': '22971888', 'type': 'BACKGROUND', 'citation': 'Pollard TM, Guell C. Assessing physical activity in Muslim women of South Asian origin. J Phys Act Health. 2012 Sep;9(7):970-6. doi: 10.1123/jpah.9.7.970.'}, {'pmid': '15111519', 'type': 'BACKGROUND', 'citation': 'Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.'}, {'pmid': '27114755', 'type': 'BACKGROUND', 'citation': 'Abuyassin B, Laher I. Diabetes epidemic sweeping the Arab world. World J Diabetes. 2016 Apr 25;7(8):165-74. doi: 10.4239/wjd.v7.i8.165.'}, {'pmid': '15038953', 'type': 'BACKGROUND', 'citation': 'Palmer AJ, Roze S, Valentine WJ, Spinas GA, Shaw JE, Zimmet PZ. Intensive lifestyle changes or metformin in patients with impaired glucose tolerance: modeling the long-term health economic implications of the diabetes prevention program in Australia, France, Germany, Switzerland, and the United Kingdom. Clin Ther. 2004 Feb;26(2):304-21. doi: 10.1016/s0149-2918(04)90029-x.'}, {'pmid': '23093136', 'type': 'BACKGROUND', 'citation': 'Lindstrom J, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinanen-Kiukaanniemi S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study (DPS). Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish Diabetes Prevention Study (DPS). Diabetologia. 2013 Feb;56(2):284-93. doi: 10.1007/s00125-012-2752-5. Epub 2012 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'This South Initiative is the first step towards a long-term general objective that aims to improve the manage-ment of type 2 diabetes (T2D) and concurrently create jobs for health professionals in Eastern Morocco by developing a multidisciplinary approach in the management of T2D, based upon international guidelines but adapted to the regional socio-economic and cultural context, and with a focus on empowerment of Muslim women.\n\nThe intermediate results of this SI project proposal are: 1) Facilitators and perceived barriers in female patients with T2D towards change to a healthier lifestyle are known. 2) Characteristics of patients with T2D in the region of Oujda (prevalence, lifestyle, age, gender,…) are analysed. 3) Master and bachelor students have gained experience by participating to relevant research. 4) All involved stakeholders shared existing and newly ac-quired knowledge and expertise. 5) Facilitators and perceived barriers in health professionals of different disciplines to work together in the management of T2D are known.', 'detailedDescription': 'The ultimate objective is to help improve the quality of life and well-being of people living with diabetes in the Oujda region.\n\nThis 2-year project will tackle the prerequisites and optimise the conditions needed to start a larger (TEAM) project. Afterwards, in the larger long-term (TEAM) project we will study the cost-of illness of T2D in Oujda, the effect of a cultural-sensitive multidisciplinary intervention for T2D and the cost-effectiveness of such an intervention. In doing so we hope to provide not only arguments from a health perspective for such an approach, but also from a quality of life and economic point of view. This is needed to persuade political decision makers to invest in sustainable innovation in health care. This could open the job market for many young physiotherapists, nutritionists and occupational therapists in health centres and primary care.\n\nThe specific objectives of this 2-year SI project are 1) to know the characteristics of T2D patients in Oujda and their perceived barriers and benefits towards participation in a lifestyle program and 2) to improve communication and cooperation between health professionals of different disciplines treating patients with T2D.\n\nThe intermediate results of this 2-year project are well defined and feasible (Annex 4). The two years of the SI project will be devoted to gathering information from diabetic women as well as from health profes-sionals, to creating a platform and to strengthening research capacities. The changes needed to reach the SI project outputs are related to 1) knowledge/capacity and 2) attitude/behaviour.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'step 1) all women, diagnosed with diabetes or not step 2) adults diagnosed with diabetes type 2', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women\n* visiting the 35 local health centres and the CRD in Oujda\n* adult\n* Moroccan\n\nExclusion Criteria:\n\n* male\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT04281069', 'briefTitle': 'Diabetes Type 2 in the Eastern Region of Morocco', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Diabetes Type 2 in the Eastern Region of Morocco , Towards an Evidence-based Multidisciplinary Lifestyle Approach in Diabetes Type 2', 'orgStudyIdInfo': {'id': 'OZ7880VLIR-S'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients visiting the "centre de santé"', 'description': 'Women visiting to the selected health centres in the Oujda province will be invited to participate'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Oujda', 'state': 'Oujda Angad', 'country': 'Morocco', 'facility': 'Université Mohammed Premier Oujda (UMP) Faculté des Sciences, Département de Biologie', 'geoPoint': {'lat': 34.68139, 'lon': -1.90858}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Artesis Plantijn University College, Antwerp', 'class': 'UNKNOWN'}, {'name': 'Université Mohammed Premier, Oujda', 'class': 'UNKNOWN'}, {'name': 'Vliruos', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associated professor', 'investigatorFullName': 'Van Rompaey Bart', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}