The Effectiveness of an Occupation-Based Lifestyle Program in Individuals With Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorAnkara Medipol University
About this trial
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.
Type 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.
In 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/physical 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Type 2 Diabetes Mellitus for at least 12 months
Aged between 18 and 74 years
Ability to provide documented proof of Type 2 diabetes diagnosis (e.g., medical report or official documentation)
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
Disqualifiers
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)
Cognitive impairment, acute psychiatric conditions, or sensory deficits (uncorrected visual or hearing impairments) that impede active participation in group sessions or online communication
Participation in another structured diabetes self-management program or lifestyle intervention trial simultaneously
Trial design
Design model
Parallel
Treatments tested in this trial
Occupation-Based Lifestyle Program
BehavioralAn 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)
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Week 0) and Post-intervention (Week 4)2
Diabetes Self-Management Questionnaire (DSMQ)
Evaluates self-care behaviors related to glycemic control, where higher scores indicate better self-management practices.
Time frame
Baseline (Week 0) and Post-intervention (Week 4)3
Occupational Balance Questionnaire (OBQ11)
Measures satisfaction with the balance of daily activities and roles, with higher scores reflecting greater occupational balance.
Time frame
Baseline (Week 0) and Post-intervention (Week 4)4
Diabetes Symptom Checklist-Revised (DSC-R)
Evaluates the presence and perceived burden of diabetes-related physical and psychological symptoms.
Time frame
Baseline (Week 0) and Post-intervention (Week 4)Sponsors and contacts
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Source ClinicalTrials.gov