Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis
NCT Number: NCT06563674
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pneumoconiosis|Healthy Lifestyle
Interventions: OTHER: Acceptance-based healthy lifestyles program (intervention group)|OTHER: Acceptance-based healthy lifestyles program (control group)
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-11
Completion Date: 2026-01

Summary:
Symptoms, such as cough and shortness of breath, are common among patients with pneumoconiosis. Depression and anxiety can be elicited by the symptoms, while avoidance of daily activities is believed to reduce trigger of symptoms. The lung function is then declined and the risk of having stroke and heart failure is increased. The objectives of this 2-arm waitlist pilot randomized controlled trial are to test the effects and feasibility of an acceptance-based educational program among patients with pneumoconiosis. 80 participants will be recruited from community centers and randomly assigned to intervention group or waitlist-control group in a ratio of 1:1. The 6-week group-based educational program will be provided to the intervention group first, then the waitlist-control group. The program consists of 4 sessions integrated with acceptance components and care of pneumoconiosis. Their psychological health, healthy lifestyles, and cardiometabolic profiles will be assessed at baseline, week 6, and week 14. Data will be analyzed using a statistical package. The feasibility of the program will be evaluated by interview. The findings of this study can inform the integration of acceptance-based intervention into pneumoconiosis management in Hong Kong, and future study on chronic progressive lung diseases.

Primary Outcome Measures: Psychological flexibility, Measured by Acceptance and Action Questionnaire-II Chinese version. It is a 7-point Likert scale with 7 items. The score ranges from 7 to 49 and a higher total score indicates less flexibility., Baseline, week 6, and week 14
Secondary Outcome Measures: Exercise-related outcome, Measured by Self-Efficacy for Exercise scale Chinese version The Chinese scale has 9 items, 11-point Likert scale. A higher total score indicates people have more self-efficacy to do exercise, range from 0 to 90., Baseline, week 6, and week 14|Practice of healthy diet, Measured by the diet subscale of the Chinese version of Health Promoting Lifestyle Profile II The subscale consists of 8 items to assess the practice of healthy diet. It is a 4-point Likert scale that a higher score indicates the more practice of healthy diet (range 8 to 32)., Baseline, week 6, and week 14|Blood pressure, Measured by validated and reliable upper-arm automated system after resting for 20 min, Baseline, week 6, and week 14|Waist circumference, Measured in nearest 0.1 centimeter, Baseline, week 6, and week 14|Body weight, Measured by a calibrated digital body monitor with participants wearing similar light clothing without shoes and socks, Baseline, week 6, and week 14|Glycated hemoglobin (HbA1c), blood test, Baseline and week 14