PneumoconiosisNCT06563674
Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis
A study testing Acceptance-based healthy lifestyles program (intervention group) in people with Pneumoconiosis and Healthy Lifestyle, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumoconiosis, Healthy Lifestyle
- What is being tested?
- Acceptance-based healthy lifestyles program (intervention group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ethnic Chinese who is able read and speak Chinese.
- Adults aged 18 or over.
- Taking compensation for pneumoconiosis.
Who cannot join
- Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment.
- Those who are unable to give written consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-led Acceptance-based Healthy Lifestyles Program for Community-dwelling Patients With Pneumoconiosis: A Waitlist Pilot Randomized Controlled Trial
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.
- Conditions
- Pneumoconiosis, Healthy Lifestyle
- Being tested
- Acceptance-based healthy lifestyles program (intervention group), Acceptance-based healthy lifestyles program (control group)
- Keywords
- Pneumoconiosis, Healthy Lifestyle, Acceptance-based
- Medical subject headings
- Pneumoconiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-based healthy lifestyles program (intervention group)Other
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.
Acceptance-based healthy lifestyles program (control group)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants will receive the acceptance-based healthy lifestyles program between week 8-14. Receives: Other: Acceptance-based healthy lifestyles program (control group) |
| Intervention | Experimental | Participants will receive the acceptance-based healthy lifestyles program between week 1-6. Receives: Other: Acceptance-based healthy lifestyles program (intervention group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 6, and week 14
Secondary outcomes (6)
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.
Measured: 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).
Measured: Baseline, week 6, and week 14
Blood pressure
Measured by validated and reliable upper-arm automated system after resting for 20 min
Measured: Baseline, week 6, and week 14
Waist circumference
Measured in nearest 0.1 centimeter
Measured: 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
Measured: Baseline, week 6, and week 14
Glycated hemoglobin (HbA1c)
blood test
Measured: Baseline and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Nov 2024
- Primary completion31 Aug 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoconiosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Lon Tam, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563674
- Sponsor's protocol ID
- temp
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available upon request and approval from the funding body.
Publications
Tam HL, Lam SKK, Ngan HY, Leung LYL, Lo SHS. An acceptance-based healthy lifestyle programme for community-dwelling patients with pneumoconiosis: A waitlist pilot randomised controlled trial. Pulmonology. 2026 Dec;32(1):2717021. doi: 10.1080/25310429.2026.2717021. Epub 2026 Aug 14.
PubMed 42599106
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Acceptance-based Healthy Lifestyles Program for Community-dwelling Patients With Pneumoconiosis: A Waitlist Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06563674
- Acronym / sponsor ID
- temp
- Conditions
- Pneumoconiosis, Healthy Lifestyle
- Keywords
- Pneumoconiosis, Healthy Lifestyle, Acceptance-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Acceptance-based healthy lifestyles program (control group)Participants will receive the acceptance-based healthy lifestyles program between week 8-14. |
| Intervention | Experimental | Other: Acceptance-based healthy lifestyles program (intervention group)Participants will receive the acceptance-based healthy lifestyles program between week 1-6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ethnic Chinese who is able read and speak Chinese.
- Adults aged 18 or over.
- Taking compensation for pneumoconiosis.
Key exclusion criteria (2 listed)
- Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment.
- Those who are unable to give written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance-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. | Other | Intervention |
| Acceptance-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. | Other | Control |
Primary outcome
Psychological flexibility
Time frame: 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.
6 secondary outcomes
Exercise-related outcome
Time frame: Baseline, week 6, and week 14
Practice of healthy diet
Time frame: Baseline, week 6, and week 14
Blood pressure
Time frame: Baseline, week 6, and week 14
Waist circumference
Time frame: Baseline, week 6, and week 14
Body weight
Time frame: Baseline, week 6, and week 14
Glycated hemoglobin (HbA1c)
Time frame: Baseline and week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 42599106Tam HL, Lam SKK, Ngan HY, Leung LYL, Lo SHS. An acceptance-based healthy lifestyle programme for community-dwelling patients with pneumoconiosis: A waitlist pilot randomised controlled trial. Pulmonology. 2026 Dec;32(1):2717021. doi: 10.1080/25310429.2026.2717021. Epub 2026 Aug 14.
- Individual participant dataSharing planned: No. Available upon request and approval from the funding body.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance-based healthy lifestyles program (intervention group) in people with Pneumoconiosis and Healthy Lifestyle, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological flexibility (time frame: Baseline, week 6, and week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.