Diabete Type 2NCT07847294
The Effectiveness of an Occupation-Based Lifestyle Program in Individuals With Type 2 Diabetes
A study testing Occupation-Based Lifestyle Program in people with Diabete Type 2 and Diabetes in Adults, run by Ankara Medipol University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabete Type 2, Diabetes in Adults
- What is being tested?
- Occupation-Based Lifestyle Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara Medipol University
Ankara
Ankara Medipol University Ankara Medipol University, info@ankaramedipol.edu.tr
- Recruiting
Ankara Medipol University
Ankara
About this study
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
Read the detailed description
Background and Rationale:
Type 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.
Study Design and Population:
This 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).
Intervention:
Participants in the intervention group will participate in an 8-session (60 minutes per session, twice weekly) online program via Zoom, structured into 5 modules:
Module 1: Awareness (Session 1): Education on diabetes management, identifying daily challenges, and establishing individual occupational priorities using the Canadian Occupational Performance Measure (COPM).
Module 2: Problem Solving (Sessions 2 \& 3): Teaching structured problem-solving steps tailored to diabetes self-management and personal goals.
Module 3: Stress Management (Sessions 4 \& 5): Training in mindfulness techniques (breath awareness, body scan, sensory awareness) and integrating them into daily routines.
Module 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.
Module 5: Goal Review and Sustainability (Session 8): Re-evaluating COPM goals, addressing barriers, and developing sustainable long-term strategies.
Participants 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.
Outcome Measures:
Data will be collected via Google Forms at baseline (pre-test) and post-intervention (post-test) using the following instruments:
Demographic and Health Information Form
Canadian Occupational Performance Measure (COPM): Evaluates occupational performance and satisfaction.
Diabetes Self-Management Questionnaire (DSMQ / DÖYS): Assesses self-care activities associated with glycemic control.
Occupational Balance Questionnaire (OBQ11-T / ARDA11-T): Measures satisfaction with the balance of daily activities and roles.
Diabetes Symptom Checklist (DSC / DBKLÖ): Evaluates the presence and burden of physical and psychological diabetes symptoms.
Short Form-36 Health Survey (SF-36): Measures health-related quality of life across 8 domains.
Program Satisfaction Survey: Evaluates intervention group feedback on program content, applicability, and online delivery.
Statistical Analysis:
Data 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 < 0.05.
- Conditions
- Diabete Type 2, Diabetes in Adults
- Being tested
- Occupation-Based Lifestyle Program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupation-Based Lifestyle ProgramBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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/physical activity, and goal setting. Receives: Behavioral: Occupation-Based Lifestyle Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Post-intervention (Week 4)
Diabetes Self-Management Questionnaire (DSMQ)
Evaluates self-care behaviors related to glycemic control, where higher scores indicate better self-management practices.
Measured: Baseline (Week 0) and Post-intervention (Week 4)
Occupational Balance Questionnaire (OBQ11)
Measures satisfaction with the balance of daily activities and roles, with higher scores reflecting greater occupational balance.
Measured: Baseline (Week 0) and Post-intervention (Week 4)
Diabetes Symptom Checklist-Revised (DSC-R)
Evaluates the presence and perceived burden of diabetes-related physical and psychological symptoms.
Measured: Baseline (Week 0) and Post-intervention (Week 4)
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.
Measured: Baseline (Week 0) and Post-intervention (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Sep 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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/routine 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Albay, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847294
- Sponsor's protocol ID
- 199
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial will be available upon reasonable request from qualified researchers after publication of the primary study results. Requests should be directed to the principal investigator and require a methodologically sound proposal and a signed data access agreement to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Occupation-Based Lifestyle Program in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07847294
- Acronym / sponsor ID
- 199
- Conditions
- Diabete Type 2, Diabetes in Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background and Rationale:
Type 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.
Study Design and Population:
This 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).
Intervention:
Participants in the intervention group will participate in an 8-session (60 minutes per session, twice weekly) online program via Zoom, structured into 5 modules:
Module 1: Awareness (Session 1): Education on diabetes management, identifying daily challenges, and establishing individual occupational priorities using the Canadian Occupational Performance Measure (COPM).
Module 2: Problem Solving (Sessions 2 \& 3): Teaching structured problem-solving steps tailored to diabetes self-management and personal goals.
Module 3: Stress Management (Sessions 4 \& 5): Training in mindfulness techniques (breath awareness, body scan, sensory awareness) and integrating them into daily routines.
Module 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.
Module 5: Goal Review and Sustainability (Session 8): Re-evaluating COPM goals, addressing barriers, and developing sustainable long-term strategies.
Participants 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.
Outcome Measures:
Data will be collected via Google Forms at baseline (pre-test) and post-intervention (post-test) using the following instruments:
Demographic and Health Information Form
Canadian Occupational Performance Measure (COPM): Evaluates occupational performance and satisfaction.
Diabetes Self-Management Questionnaire (DSMQ / DÖYS): Assesses self-care activities associated with glycemic control.
Occupational Balance Questionnaire (OBQ11-T / ARDA11-T): Measures satisfaction with the balance of daily activities and roles.
Diabetes Symptom Checklist (DSC / DBKLÖ): Evaluates the presence and burden of physical and psychological diabetes symptoms.
Short Form-36 Health Survey (SF-36): Measures health-related quality of life across 8 domains.
Program Satisfaction Survey: Evaluates intervention group feedback on program content, applicability, and online delivery.
Statistical Analysis:
Data 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 < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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/routine 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Occupation-Based Lifestyle ProgramParticipants 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/physical activity, and goal setting. |
| 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupation-Based Lifestyle ProgramAn 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) | Behavioural | Intervention Group |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline (Week 0) and Post-intervention (Week 4)
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.
Diabetes Self-Management Questionnaire (DSMQ)
Time frame: Baseline (Week 0) and Post-intervention (Week 4)
Evaluates self-care behaviors related to glycemic control, where higher scores indicate better self-management practices.
Occupational Balance Questionnaire (OBQ11)
Time frame: Baseline (Week 0) and Post-intervention (Week 4)
Measures satisfaction with the balance of daily activities and roles, with higher scores reflecting greater occupational balance.
Diabetes Symptom Checklist-Revised (DSC-R)
Time frame: Baseline (Week 0) and Post-intervention (Week 4)
Evaluates the presence and perceived burden of diabetes-related physical and psychological symptoms.
Short Form-36 Health Survey (SF-36)
Time frame: Baseline (Week 0) and Post-intervention (Week 4)
Measures health-related quality of life across physical and mental health domains, with higher scores reflecting better health status.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the trial will be available upon reasonable request from qualified researchers after publication of the primary study results. Requests should be directed to the principal investigator and require a methodologically sound proposal and a signed data access agreement to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupation-Based Lifestyle Program in people with Diabete Type 2 and Diabetes in Adults, run by Ankara Medipol University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sena Albay, Msc (+90 5062511706, sena.albay@ankaramedipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: Baseline (Week 0) and Post-intervention (Week 4)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.