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RecruitingNCT07847294Updated Sep 29, 2026

The Effectiveness of an Occupation-Based Lifestyle Program in Individuals With Type 2 Diabetes

An interventional study of Occupation-Based Lifestyle Program in Diabete Type 2 and Diabetes in Adults, sponsored by Ankara Medipol University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Ankara Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Sep 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Diabete Type 2
  • Diabetes in Adults
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 42 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Ankara Medipol University is the lead sponsor of 55 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    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.

    Behavioral: Occupation-Based Lifestyle Program

  • No intervention
    Control Group

    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.

Interventions

  • BehavioralOccupation-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)

06

What researchers measure

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)

  5. 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.

    Time frame: Baseline (Week 0) and Post-intervention (Week 4)

07

Study locations

2 of 2 sites recruiting
  • Ankara Medipol University
    Ankara, Turkey (Türkiye)
    Recruiting
  • Ankara Medipol University
    Ankara, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Analytic code

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07847294
Lead sponsor
Ankara Medipol University
Responsible party
Sena Albay (Lecturer, Ankara Medipol University) — Principal investigator
First posted
Sep 29, 2026
Start date
Sep 1, 2026
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 29, 2026

Study contacts

Sena Albay, Msc
Contact
sena.albay@ankaramedipol.edu.tr
+90 5062511706

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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