The Effectiveness of an Occupation-Based Lifestyle Program in Individuals With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Occupation-Based Lifestyle Program (Behavioral)
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.
结局指标
主要结局
Canadian Occupational Performance Measure (COPM)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Sena Albay
Lecturer
Ankara Medipol University