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

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

Recruiting
18-74 years
All
Phase N/A

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Overview

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

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.

Eligibility

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:

  • 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

Study details
    Diabete Type 2
    Diabetes in Adults

NCT07847294

Ankara Medipol University

3 October 2026

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