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

NCT07847294 | Recruiting

• 1 other identifier: 199
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Diabete Type 2; Diabetes in Adults

Outcome Measures

Primary Outcomes (5)

• 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)

• Diabetes Self-Management Questionnaire (DSMQ)

  Evaluates self-care behaviors related to glycemic control, where higher scores indicate better self-management practices.

  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.

  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.

  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.

  Baseline (Week 0) and Post-intervention (Week 4)

Study Arms (2)

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.

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.

Interventions

Occupation-Based Lifestyle Program BEHAVIORAL

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)

Intervention Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (2)

Ankara Medipol University

Ankara, Turkey (Türkiye)

RECRUITING

Ankara Medipol University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Sena Albay, Msc

CONTACT

+90 5062511706; sena.albay@ankaramedipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Available upon reasonable request starting 6 months following the publication of the primary study results and ending 3 years after the publication date.
• Access Criteria: Qualified academic researchers with a methodologically sound research proposal aimed at achieving the approved objectives will be granted access to de-identified individual participant data. Requesters must submit a formal research protocol and sign a Data Access Agreement with the principal investigator to ensure participant privacy and data security.

Locations

TU (2)