[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658048":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":35,"studyPopulation":25,"armGroups":36,"interventions":47,"overallOfficials":25,"centralContacts":53,"locations":59,"responsibleParty":78,"collaborators":25,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":25,"eligibilityCriteria":87,"healthyVolunteers":84,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":25,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Ankara Medipol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":25},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Canadian Occupational Performance Measure (COPM)","Assesses individual occupational performance and satisfaction in self-care, productivity, and leisure domains. Scores range from 1 to 10 for both subscales, with higher scores indicating higher self-perceived performance and satisfaction.","Baseline (Week 0) and Post-intervention (Week 4)",{"measure":14,"description":15,"timeFrame":12},"Diabetes Self-Management Questionnaire (DSMQ)","Evaluates self-care behaviors related to glycemic control, where higher scores indicate better self-management practices.",{"measure":17,"description":18,"timeFrame":12},"Occupational Balance Questionnaire (OBQ11)","Measures satisfaction with the balance of daily activities and roles, with higher scores reflecting greater occupational balance.",{"measure":20,"description":21,"timeFrame":12},"Diabetes Symptom Checklist-Revised (DSC-R)","Evaluates the presence and perceived burden of diabetes-related physical and psychological symptoms.",{"measure":23,"description":24,"timeFrame":12},"Short Form-36 Health Survey (SF-36)","Measures health-related quality of life across physical and mental health domains, with higher scores reflecting better health status.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"NON_RANDOMIZED","PARALLEL","This study employs a non-randomized, quasi-experimental controlled trial design with two parallel groups: an intervention group and a waitlist control group. Participants diagnosed with Type 2 diabetes are assigned to either the intervention or control group. The intervention group receives an 8-session, online \"Occupation-Focused Lifestyle Program\" over 4 weeks (2 sessions per week) via Zoom. The waitlist control group receives standard\u002Froutine care during the study period and is provided with an informative educational brochure containing the program topics upon completion of the intervention group's post-test evaluations. Outcome measures are collected online at baseline (pre-test) and immediately following the completion of the 8-session intervention (post-test) for both groups.","TREATMENT",{"masking":32,"maskingDescription":25,"whoMasked":33},"SINGLE",[34],"OUTCOMES_ASSESSOR","Background and Rationale:\n\nType 2 diabetes mellitus accounts for 90-95% of diabetes cases worldwide and presents significant challenges in physical and psychosocial functioning. Effective management requires long-term lifestyle adaptations, including healthy eating, physical activity, blood glucose monitoring, medication adherence, problem-solving, and stress management. While traditional lifestyle interventions improve clinical indicators in the short term, their long-term behavioral sustainability can be limited. Occupation-focused occupational therapy interventions integrate diabetes self-management into daily habits and meaningful roles, offering a structured framework to improve quality of life and health outcomes.\n\nStudy Design and Population:\n\nThis study is a quasi-experimental controlled trial conducted online. The target population consists of individuals aged 18-74 who have been diagnosed with Type 2 diabetes for more than 12 months, have internet access for online sessions, and provide documented proof of their diagnosis. Sample size calculation using G\\*Power (alpha = 0.05, power = 0.80, effect size d = 0.8) determined a required total sample size of 42 participants (21 per group).\n\nIntervention:\n\nParticipants in the intervention group will participate in an 8-session (60 minutes per session, twice weekly) online program via Zoom, structured into 5 modules:\n\nModule 1: Awareness (Session 1): Education on diabetes management, identifying daily challenges, and establishing individual occupational priorities using the Canadian Occupational Performance Measure (COPM).\n\nModule 2: Problem Solving (Sessions 2 \\& 3): Teaching structured problem-solving steps tailored to diabetes self-management and personal goals.\n\nModule 3: Stress Management (Sessions 4 \\& 5): Training in mindfulness techniques (breath awareness, body scan, sensory awareness) and integrating them into daily routines.\n\nModule 4: Energy Conservation and Physical Activity (Sessions 6 \\& 7): Instruction on activity-role balance, energy conservation principles, and embedding safe physical activities (walking, home exercises) into daily life.\n\nModule 5: Goal Review and Sustainability (Session 8): Re-evaluating COPM goals, addressing barriers, and developing sustainable long-term strategies.\n\nParticipants in the control group will receive an informative educational brochure (covering diabetes awareness, problem-solving, physical activity, mindfulness, and energy conservation) upon completion of the intervention group's program.\n\nOutcome Measures:\n\nData will be collected via Google Forms at baseline (pre-test) and post-intervention (post-test) using the following instruments:\n\nDemographic and Health Information Form\n\nCanadian Occupational Performance Measure (COPM): Evaluates occupational performance and satisfaction.\n\nDiabetes Self-Management Questionnaire (DSMQ \u002F DÖYS): Assesses self-care activities associated with glycemic control.\n\nOccupational Balance Questionnaire (OBQ11-T \u002F ARDA11-T): Measures satisfaction with the balance of daily activities and roles.\n\nDiabetes Symptom Checklist (DSC \u002F DBKLÖ): Evaluates the presence and burden of physical and psychological diabetes symptoms.\n\nShort Form-36 Health Survey (SF-36): Measures health-related quality of life across 8 domains.\n\nProgram Satisfaction Survey: Evaluates intervention group feedback on program content, applicability, and online delivery.\n\nStatistical Analysis:\n\nData analysis will be performed using SPSS (Version 26.0). Descriptive statistics will summarize participant characteristics. Within-group pre-post changes and between-group differences will be analyzed using parametric tests (paired t-test, independent samples t-test) or non-parametric tests (Wilcoxon signed-rank test, Mann-Whitney U test) depending on normality distributions, with significance set at p \\\u003C 0.05.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Intervention Group","EXPERIMENTAL","Participants receive an online, 5-module (8 sessions, twice weekly, 60 minutes each via Zoom) Occupation-Focused Lifestyle Program. The program covers diabetes awareness, problem-solving, stress management (mindfulness), energy conservation\u002Fphysical activity, and goal setting.",[42],"Behavioral: Occupation-Based Lifestyle Program",{"label":44,"type":45,"description":46,"interventionNames":25},"Control Group","NO_INTERVENTION","Participants maintain their routine care during the study period. After the intervention group completes the program and post-tests, the control group receives an informative educational brochure covering the program topics.",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":25},"BEHAVIORAL","Occupation-Based Lifestyle Program","An online, 5-module (8 sessions, 60 minutes each, twice weekly via Zoom) intervention led by occupational therapy staff. The program incorporates diabetes awareness, structured problem-solving, stress management (mindfulness), energy conservation, safe physical activity integration, and goal setting using the Canadian Occupational Performance Measure (COPM)",[38],[54],{"name":55,"role":56,"phone":57,"phoneExt":25,"email":58},"Sena Albay, Msc","CONTACT","+90 5062511706","sena.albay@ankaramedipol.edu.tr",[60,74],{"facility":5,"status":61,"city":62,"state":25,"zip":25,"country":63,"countryCode":25,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Ankara","Turkey (Türkiye)",{"type":65,"coordinates":66},"Point",[67,68],32.85427,39.91987,{"lat":68,"lon":67},[71],{"name":72,"role":56,"phone":25,"phoneExt":25,"email":73},"Ankara Medipol University Ankara Medipol University","info@ankaramedipol.edu.tr",{"facility":5,"status":61,"city":62,"state":25,"zip":25,"country":63,"countryCode":25,"cosmosGeoPoint":75,"geoPoint":77,"contacts":25},{"type":65,"coordinates":76},[67,68],{"lat":68,"lon":67},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Sena Albay","Lecturer","100658048","the-effectiveness-of-an-occupation-based-lifestyle-program-in-individuals-with-type-2-diabetes-100658048",false,"NCT07847294","The Effectiveness of an Occupation-Based Lifestyle Program in Individuals With Type 2 Diabetes","Inclusion Criteria:\n\n* Diagnosed with Type 2 Diabetes Mellitus for at least 12 months\n* Aged between 18 and 74 years\n* Ability to provide documented proof of Type 2 diabetes diagnosis (e.g., medical report or official documentation)\n* Having access to a smartphone, tablet, or computer with an internet connection to attend online Zoom sessions and complete online questionnaires -Voluntary agreement to participate in the study and submission of an online informed consent form\n\nExclusion Criteria:\n\n* Presence of severe diabetic complications that significantly impair independent daily function (e.g., severe proliferative retinopathy, end-stage renal disease, active foot ulcers, or severe diabetic neuropathy)\n* Cognitive impairment, acute psychiatric conditions, or sensory deficits (uncorrected visual or hearing impairments) that impede active participation in group sessions or online communication\n* Participation in another structured diabetes self-management program or lifestyle intervention trial simultaneously","ALL","18 Years","74 Years",{"count":92,"type":93},42,"ESTIMATED","INTERVENTIONAL",[96],"NA","This study aims to investigate the effect of an occupation-focused lifestyle program on occupational performance, self-management, occupational balance, diabetes symptoms, and quality of life in individuals with Type 2 diabetes.\n\nType 2 diabetes requires continuous daily management, yet conventional interventions often show limited long-term behavioral sustainability. Occupation-focused lifestyle interventions offer a holistic approach by addressing daily routines, self-management skills, and personal goals.\n\nIn this non-invasive, quasi-experimental study, participants aged 18-74 with Type 2 diabetes will be invited via social media announcements. Participants will be divided into an intervention group and a control group. The intervention group will receive an online, 5-module (8 sessions) Occupation-Focused Lifestyle Program via Zoom, covering diabetes awareness, problem-solving, stress management (mindfulness), energy conservation\u002Fphysical activity, and goal review. The control group will receive an informative brochure after the intervention group completes the program. Outcomes will be measured online before and after the program using structured scales to evaluate changes in daily functioning, self-care, and overall well-being",[99,100],"Diabete Type 2","Diabetes in Adults","2026-09-28",{"date":103,"type":104},"2026-09-29","ACTUAL",{"date":106,"type":104},"2026-09-01",{"date":108,"type":93},"2026-12",{"name":5,"class":6},2]