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NCT Number: NCT06563674

Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PMAA

Hong Kong

Location status: Recruiting

Location contact

Mr. Tsang

CONTACT

853 23861666

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ethnic Chinese who is able read and speak Chinese.
  • Adults aged 18 or over.
  • Taking compensation for pneumoconiosis.

Exclusion criteria

  • Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment.
  • Those who are unable to give written consent.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. Blood pressure

    Time frame: Baseline, week 6, and week 14

    Measured by validated and reliable upper-arm automated system after resting for 20 min

  4. Waist circumference

    Time frame: Baseline, week 6, and week 14

    Measured in nearest 0.1 centimeter

  5. 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

  6. Glycated hemoglobin (HbA1c)

    Time frame: Baseline and week 14

    blood test

Study contacts

Contact information is provided by the study sponsor or research team.

Hon Lon Tam, PhD

CONTACT

[email protected]

39439306

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Nurse-led Acceptance-based Healthy Lifestyles Program for Community-dwelling Patients With Pneumoconiosis: A Waitlist Pilot Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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