Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-28 @ 1:50 PM
Study NCT ID:
NCT06570057
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2024-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel study design would be used. Six clusters will be randomly selected from purely urban blocks of Karachi. The study sites will be selected in a manner that the risk of possible contamination between control and intervention groups is avoided. The intervention clusters will receive the 18-months long PLA intervention along with study assessments, while the control clusters will only go through assessments i.e., at baseline and end of study. A referral mechanism will be followed for both intervention and control arm, which will ensure that the individuals with newly diagnosed diabetes will be referred to the nearest diabetes care facility.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Type II Diabetes Mellitus', 'timeFrame': '18 months', 'description': 'HbA1c biochemical test'}, {'measure': 'Two-year cumulative incidence of Type II Diabetes Mellitus', 'timeFrame': '18 months', 'description': 'HbA1c biochemical test'}], 'secondaryOutcomes': [{'measure': 'Mean diastolic and systolic blood pressure', 'timeFrame': '18 months', 'description': 'Digital blood pressure monitoring'}, {'measure': 'Prevalence of hypertension', 'timeFrame': '18 months', 'description': 'Digital BP monitoring'}, {'measure': 'Abdominal obesity', 'timeFrame': '18 months', 'description': 'Waist-to-hip circumference ratio'}, {'measure': 'Mean body mass index', 'timeFrame': '18 months', 'description': 'Height and weight will be taken'}, {'measure': 'Health-related quality of life', 'timeFrame': '18 months', 'description': 'World Health Organization Quality of Life (WHOQOL) BREF questionnaire'}, {'measure': 'Frequency of depression', 'timeFrame': '18 months', 'description': 'Patient Health Questionnaire (PHQ-9)'}, {'measure': 'Mean body fat percentage', 'timeFrame': '18 months', 'description': 'Using impedance analyzer'}, {'measure': 'Prevalence of overweight and obesity', 'timeFrame': '18 months', 'description': 'Height and weight will be taken'}, {'measure': 'Frequency of anxiety', 'timeFrame': '18 months', 'description': 'Generalized Anxiety Disorder (GAD-7) Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Community-Based Participatory Research', 'Participatory Learning and Action Research', 'Type II Diabetes Mellitus', 'Intermediate hyperglycemia'], 'conditions': ['Type II Diabetes Mellitus']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Imtiaz S, Afaq S, Jennings HM, Tahir A, Sanauddin N, Khaleeq N, et al. Community Health Participatory (CHP) Interventions in the Prevention and Control of Non-communicable Diseases in conflict-affected LMICs- A Scoping Review Protocol [Internet]. OSF; 2024.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.17605/OSF.IO/EU95B', 'label': 'OSF registration link'}]}, 'descriptionModule': {'briefSummary': 'This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.', 'detailedDescription': 'The pivotal components of this approach include adapting, implementing, and evaluating the Participatory Learning and Action (PLA) based intervention for the prevention and control of Type II diabetes (TIIDM). TIIDM is considered the fastest-growing health emergency, affecting 537 million adults worldwide. Global projections for the year 2045 suggest that a 12.2% rise in TIIDM is anticipated with an additional 11.4% rise for intermediate hyperglycemia (IHG). Around 80% of people with TIIDM reside in low-and middle-income countries (LMICs), exhausting the already burdened healthcare system.\n\nThe intervention, adapted from the "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh (DMagic)" trial, has been tested and found effective in the rural context of Bangladesh. However, PLA-based intervention has not been previously tested in urban communities. Considering the distinct sociocultural environment of urban settings, a feasibility trial will be conducted in urban Karachi, Pakistan.\n\nThe feasibility trial will assess the intervention\'s adaptability and effectiveness in this new context. It is anticipated that the use of evidence-based approaches, best practices, and meaningful community participation through PLA will enhance the social and behavioral determinants of health and lead to improved health outcomes. This approach aims to control TIIDM and pave the way for managing other non-communicable diseases through similar focused interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 20 years and above.\n* Participants residing in the randomized clusters of Karachi, Pakistan\n* Individuals willing to participate in the study and provide consent.\n* Both individuals with normoglycemia, intermediate hyperglycemia, and diabetes are encouraged to participate.\n* Participants who can attend the scheduled meetings and interventions as per the study protocol.\n\nExclusion Criteria:\n\n* Individuals below the age of 20 years.\n* Individuals unwilling to provide consent for participation.\n* Participants with severe health conditions that may hinder their active involvement in the study.\n* Individuals with non-compliance with research protocols'}, 'identificationModule': {'nctId': 'NCT06570057', 'acronym': 'EMPOWER-D', 'briefTitle': 'Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Baqai Institute of Diabetology and Endocrinology'}, 'officialTitle': 'Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]: Feasibility Trial in Urban Pakistan', 'orgStudyIdInfo': {'id': 'EMPOWERD-FT-UPK-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Community mobilization will be done via male and female community groups using a PLA Cycle whereby groups themselves identify and priorities problems associated with diabetes and the risk of developing diabetes. Next this study will plan strategies to address the problems identified in the community, put these strategies into practice and, finally, evaluate the effectiveness of these strategies. Lay facilitators will convene the groups monthly over a period of 18 months, with one meeting per month.', 'interventionNames': ['Behavioral: Participatory, learning and Action (PLA) Based intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The Control Group will not receive the PLA (Participatory Learning and Action) intervention. However, they will still benefit from the study in several ways. Information about the trial and guidance on who to contact in case of hyperglycemia or intermediate hyperglycemia will be provided. The disease burden in the control area will be monitored, and findings will be included in national and international advocacy and dissemination efforts'}], 'interventions': [{'name': 'Participatory, learning and Action (PLA) Based intervention', 'type': 'BEHAVIORAL', 'description': 'An PLA based intervention would be carried out to prepare the Diabetes Mellitus type II patients. The intervention would be carried out for a tentative time of 2 to 3 hours to educate the type II diabetes mellitus. The study participants would be evaluated after completion of 18 months of the intervention. A structured, validated and literature-based assessment checklist will be devised to assess the effectiveness and feasibility of the intervention.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Rubia Zafar, TrialManager', 'role': 'CONTACT', 'email': 'rzafar@bide.edu.pk', 'phone': '922136688897'}, {'name': 'Sara Imtiaz', 'role': 'CONTACT', 'email': 'simtiaz@bide.edu.pk'}, {'name': 'Abdul Basit, Director', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baqai Institute of Diabetology and Endocrinology (BIDE)', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Abdul Basit, Director', 'role': 'CONTACT', 'email': 'abdulbasit@bide.edu.pk', 'phone': '922136688897'}, {'name': 'Rubia Zafar, TrialManager', 'role': 'CONTACT', 'email': 'rzafar@bide.edu.pk'}], 'overallOfficials': [{'name': 'Abdul Basit, Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baqai Institute of Diabetes and Endocrinology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Data requests can be submitted starting 12 months after article publication', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interested in the stated study area after its proper monitoring. Data or samples shared will be coded, with no PHI included. Prior permission of the investigators, participants and concerned departments will be obtained.', 'accessCriteria': 'Access can be requested by qualified researchers through proper approval of the investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baqai Institute of Diabetology and Endocrinology', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of York', 'class': 'OTHER'}, {'name': 'Khyber Medical University Peshawar', 'class': 'OTHER'}, {'name': 'HealthNet TPO', 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Aga Khan University Hospital, Pakistan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Abdul Basit', 'investigatorAffiliation': 'Baqai Institute of Diabetology and Endocrinology'}}}}