Healthy Lifestyle, Pneumoconiosis
Conditions
Keywords
Pneumoconiosis, Healthy Lifestyle, Acceptance-based
Brief 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.
Interventions
OTHERAcceptance-based healthy lifestyles program (intervention group)
The acceptance-based healthy lifestyles program consists of 4 biweekly 60-min face-to-face interactive workshops to cover the knowledge of pneumoconiosis, exercise to maintain lung function, health diet, and home safety.
OTHERAcceptance-based healthy lifestyles program (control group)
The acceptance-based healthy lifestyles program consists of 4 biweekly 60-min face-to-face interactive workshops to cover the knowledge of pneumoconiosis, exercise to maintain lung function, health diet, and home safety.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The baseline data will be collected by research assistant (RA)1 before randomization, while the follow-ups data will be collected by RA2. The participant's group allocation is masked to the outcome assessors. But the participants know their group allocation after randomization because of the nature of the intervention. Different dates will be planned for different groups for all follow-ups respectively to avoid contamination of the subjects and blinding to the outcome assessors as far as possible
Intervention model description
A 2-arm waitlist pilot randomized controlled trial will be adopted. After baseline data collection, participants in the intervention group will receive the health program for 6 weeks. On the other hand, participants in the waitlist-control group will receive the same health program week 8 and week 14.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ethnic Chinese who is able read and speak Chinese. 2. Adults aged 18 or over. 3. Taking compensation for pneumoconiosis.
Exclusion criteria
1. Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment. 2. Those who are unable to give written consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological flexibility | Baseline, week 6, and week 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Practice of healthy diet | Baseline, week 6, and week 14 | 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). |
| Blood pressure | Baseline, week 6, and week 14 | Measured by validated and reliable upper-arm automated system after resting for 20 min |
| Exercise-related outcome | Baseline, week 6, and week 14 | 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. |
| Body weight | Baseline, week 6, and week 14 | Measured by a calibrated digital body monitor with participants wearing similar light clothing without shoes and socks |
| Glycated hemoglobin (HbA1c) | Baseline and week 14 | blood test |
| Waist circumference | Baseline, week 6, and week 14 | Measured in nearest 0.1 centimeter |
Countries
Hong Kong
Contacts
Primary ContactHon Lon Tam, PhD
Outcome results
None listed