Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis

April 9, 2025 updated by: Hon Lon Tam, Chinese University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • PMAA
        • Contact:
          • Mr. Tsang
          • Phone Number: 853 23861666

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Participants will receive the acceptance-based healthy lifestyles program between week 8-14.
Other: 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.
Experimental: Intervention
Participants will receive the acceptance-based healthy lifestyles program between week 1-6.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 6, and week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise-related outcome
Time Frame: 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.
Baseline, week 6, and week 14
Practice of healthy diet
Time Frame: 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).
Baseline, week 6, and week 14
Blood pressure
Time Frame: Baseline, week 6, and week 14
Measured by validated and reliable upper-arm automated system after resting for 20 min
Baseline, week 6, and week 14
Waist circumference
Time Frame: Baseline, week 6, and week 14
Measured in nearest 0.1 centimeter
Baseline, week 6, and week 14
Body weight
Time Frame: Baseline, week 6, and week 14
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)
Time Frame: Baseline and week 14
blood test
Baseline and week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • temp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Available upon request and approval from the funding body.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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