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NCT Number: NCT07702994

Effects of Adapted Snacktivity™ Intervention on Cognition and Self-Care in COPD Patients

This clinical trial aims to evaluate whether a culturally adapted Snacktivity™ program can improve cognitive function and self-care abilities in patients with Chronic Obstructive Pulmonary Disease (COPD) in Hong Kong.

The main questions it aims to answer are:

1. Does the Snacktivity™ program improve the cognitive function of participants (including both global cognition and targeted subdomains)? 2. Does the program improve participants' self-care abilities?

The study consists of three sequential phases:

Phase 1 (Co-design workshops): Co-design workshops will be conducted with COPD patients, healthcare professionals (nurses, physical therapists, occupational therapists), and family caregivers to culturally adapt the Snacktivity™ program for Hong Kong COPD patients.

Phase 2 (Feasibility Pilot RCT): The adapted program will be tested in a small-scale pilot study to assess its feasibility and short-term clinical effects.

Phase 3 (Full-scale RCT): A full-scale randomised controlled trial will be conducted to evaluate the program's efficacy on the primary and secondary outcomes.

Participants in the intervention group will be asked to:

Participate in the culturally adapted Snacktivity™ program that integrates short, manageable "snacks" of physical activity into daily routines.

Wear an activity tracker to monitor physical activity levels. Complete questionnaires at multiple time points assessing cognitive function, self-care abilities, physical activity levels, self-efficacy, exercise capacity, quality of life, anxiety, and depression.

Researchers will compare the intervention group to an attention control group (receiving usual care with health education) to see if the Snacktivity™ program leads to greater improvements in these outcomes.

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Key information

About this study

  • Background and Research Gaps: Chronic Obstructive Pulmonary Disease (COPD) is a severe global public health issue. In Hong Kong, COPD remains the second most common cause of respiratory hospitalisation, and 56% of COPD patients experience cognitive impairment (CI), which profoundly impacts patients' self-care abilities and quality of life. Despite a robust theoretical foundation, Snacktivity™ has not yet been validated for patients with COPD, and no randomised controlled trials have confirmed its efficacy in enhancing cognitive function and self-care abilities in this population. Two critical research gaps must be addressed: (1) the suitability of its current activity templates for COPD patients, and (2) the feasibility of its implementation in home and workplace settings. Nurses, physical therapists, occupational therapists, and caregivers offer complementary insights into practical challenges, patient-specific barriers, treatment adherence, and resource allocation requirements essential for tailoring the program to Hong Kong's contextual needs.

2 Study Objectives:

  • To explore the feasibility, acceptability, motivating factors, perceived barriers, and preferred formats of the culturally adapted Snacktivity™ program among COPD patients in Hong Kong, and to investigate stakeholders' perspectives, recommendations, and concerns regarding its implementation.
  • To examine the short-term and long-term effects of the culturally adapted Snacktivity™ program on patients' cognitive function and self-care abilities (primary outcomes), as well as on physical activity levels, self-efficacy, exercise capacity, health-related quality of life, anxiety, and depression (secondary outcomes).
  • To explore the overall efficacy and sustainable implementability of the culturally adapted Snacktivity™ program for COPD patients in Hong Kong.

3 Study Design: This is a three-phase sequential study.

  • Phase 1 (Co-design): Co-design workshops will be conducted with COPD patients (n=15), multidisciplinary healthcare professionals (nurses=6, physical therapists=6, occupational therapists=9), and family caregivers (n=6). The aim is to culturally adapt the Snacktivity™ program for Hong Kong COPD patients by gathering diverse perspectives on practical challenges, patient-specific barriers, treatment adherence, and preferred intervention formats. The co-design process follows a four-stage approach: Stage 1 (patient-only workshop), Stage 2 (multi-stakeholder workshop), Stage 3 (WhatsApp asynchronous feedback), and Stage 4 (patient final validation workshop).
  • Phase 2 (Feasibility Pilot RCT): A small-scale pilot randomised controlled trial will be conducted with 50 COPD patients (25 per group) to test the adapted program's feasibility and short-term clinical effects. The intervention lasts 12 weeks, with assessments at baseline and immediately post-intervention. Feasibility outcomes include recruitment and retention rates, intervention adherence, and dropout rates. This phase primarily evaluates feasibility outcomes to inform the design of the subsequent full-scale trial. Clinical outcomes measured in this phase include:
  • Cognitive function, assessed by the Hong Kong Montreal Cognitive Assessment (HK-MoCA) for global cognition, the Auditory Verbal Learning Test (AVLT) for memory, the Animal Fluency Test (AFT) for language, the Shape Trails Test (STT) for executive function, and the Digit Span Test (DST) for attention.
  • Self-care abilities, assessed by the Community COPD Self-Management Scale.
  • Physical activity levels, assessed by the Physical Activity Scale for the Elderly-Chinese version (PASE-C).
  • Self-efficacy, assessed by the Exercise Self-Regulatory Efficacy Scale-Chinese version (Ex-SRES-Chinese).
  • Exercise capacity, assessed by the 6-minute walk test (6MWT).
  • Health-related quality of life, assessed by the COPD Assessment Test (CAT).
  • Anxiety, assessed by the Generalised Anxiety Disorder-7 (GAD-7) scale.
  • Depression, assessed by the Patient Health Questionnaire-9 (PHQ-9)
  • Phase 3 (Full-scale RCT): A full-scale randomised controlled trial will be conducted with 160 COPD patients (80 per group) to evaluate the program's efficacy on the primary and secondary outcomes. The intervention duration and frequency remain consistent with Phase 2, but the content will be optimised based on Phase 2 findings. A 3-month post-intervention follow-up will be added to assess long-term effects. Assessments will occur at baseline, immediately post-intervention (Week 12), and 3 months post-intervention. This phase primarily evaluates clinical efficacy, with the same outcome measures and assessment tools as described in Phase 2.
  • Hypotheses:
  • The culturally adapted Snacktivity™ program will demonstrate high feasibility among COPD patients in Hong Kong.
  • COPD patients participating in the culturally adapted Snacktivity™ program will show significant improvements in cognitive function and self-care abilities (primary outcomes), as well as in physical activity levels, self-efficacy, exercise capacity, health-related quality of life, and reductions in anxiety and depression (secondary outcomes), compared to the attention control group.
  • The culturally adapted Snacktivity™ intervention program will exhibit overall effectiveness and sustainable implementability among COPD patients in Hong Kong.

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria:
  • Confirmed diagnosis of COPD in accordance with the 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline, with a post-bronchodilator ratio of FEV₁/FVC < 70%;
  • Aged ≥ 60 years;
  • Clinically stable condition;
  • Score at or below the age- and education-adjusted cutoff (16th percentile) on the Hong Kong Montreal Cognitive Assessment (HK-MoCA) 5-minute Protocol, indicating mild cognitive impairment;
  • No exercise contraindications;
  • No active wrist skin conditions that would prevent wearing an activity tracker (Phase 2 & 3);
  • Willingness to wear an activity tracker during the intervention (Phase 2 & 3);
  • Possession of a smartphone capable of receiving instant messages (Phase 2 & 3);
  • Proficiency in Cantonese or Mandarin;
  • Willingness to provide written informed consent and commitment to trial completion.
  • Exclusion Criteria
  • Receipt of oxygen therapy for ≥ 15 hours per day or requirement for mechanical ventilation;
  • History of brain injury or stroke;
  • Presence of severe comorbidities including coronary artery disease, severe hepatic or renal dysfunction;
  • Diagnosis of psychiatric disorders, deafness, severely limited physical mobility, or inability to cooperate with trial interventions;
  • For Phase 2 and Phase 3: Use of medications documented to impact cognitive function.

Treatment and study plan

Snacktivity™ Intervention

Behavioral

Participants in this arm receive the culturally adapted Snacktivity™ program. The intervention integrates short, manageable "snacks" of moderate-intensity physical activity (2-5 minutes per session, 5-6 sessions per day) into daily routines to accumulate at least 150 minutes of physical activity per week. Participants wear a Garmin activity tracker to objectively monitor physical activity levels. The intervention lasts 12 weeks and includes a 30-minute pre-intervention guidance session, a self-guided manual with illustrated activity templates, and structured follow-up support consisting of one weekly 30-minute in-depth session and two weekly 10-15-minute brief sessions. During each follow-up session, researchers recommend specific activity templates based on the participant's reported daily routine and co-develop a personalized 2-3 day activity schedule, which is documented in the participant's training manual.

Attention Control

Behavioral

Participants in this arm receive usual care plus additional attention to control for the non-specific effects of time and contact. They attend a single 60-minute group health education session on general lifestyle modification, based on the Hospital Authority's "COPD Self-Management Guide" (3rd Edition), with no physical activity advice or recommendations provided. During the 12-week intervention period, they receive the same two-tier follow-up schedule as the intervention group (one weekly 30-minute session and two weekly 10-15-minute brief sessions), focusing on general lifestyle assessment (e.g., sleep quality, nutrition, mood) and encouragement to maintain healthy behaviors, without any physical activity planning or template selection.

Primary outcomes

  1. Global cognition

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    Global cognition will be assessed using the HK-MoCA. Developed originally by Dr. Ziad S. Nasreddine, the HK-MoCA is a validated and sensitive tool for global cognitive screening, which is specifically adapted to evaluate the cognitive status of patients in the Hong Kong region.

  2. Memory

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    We employed the Huashan version of the Auditory Verbal Learning Test (AVLT) adapted by Guo et al., to assess participants' memory. The test materials consist of three categories of nouns (clothing, occupations, and flowers), each with four related words, for a total of 12 target words. The test procedures and scoring methods are as follows: First, an immediate recall task is conducted. Participants are required to recall the 12 target words immediately after the tester reads them aloud, and this process is repeate times. The total score of immediate recall is the sum of the number of correctly recalled words in the three consecutive tests, with a maximum score of 36. Subsequently, delayed recall tasks are performed after 5 minutes (short-term delayed recall) and 20 minutes (long-term delayed recall), requiring participants to recall the target words. Meanwhile, a cued recall task is added, which requires participants to recall the words by category. The individual total scores for

  3. Language

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    The Animal Fluency Test (AFT) is used to assess the language function of the participants. The specific requirements are: the participants need to name as many different animals as possible within 1 minute, and the number of animals listed is used as the evaluation indicator. The results are judged based on the educational level: for those with junior high school education or below, if the number is less than 12; for those with high school education, if the number is less than 12; for those with college education or above, if the number is less than 14, all of which are judged as abnormal results. The lower the score of this test, the worse the language function of the participant.

  4. Executive function

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    The Shape Trails Test (STT), a subtest of the Halstead-Reitan Neuropsychological Test Battery, is used to assess the executive function of participants.

  5. Attention

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    The Digit Span Test (DST) is employed to assess participants' attentional functions. The specific procedure was as follows: the examiner recited a series of digits, requiring participants to reproduce the digit sequences in both forward and backwards order. In the forward span task, the examiner presented digit sequences at a rate of 1 digit per second, starting with 3-digit sequences and incrementing by 1 digit each time up to 12-digit sequences. Each digit length category contained 2 test items. If the participant failed the first trial, the second trial was administered; the testing for that digit length was terminated only when both trials were failed. If the participant succeeded in the first trial, they proceeded to the next digit length category. The backward span task followed the same operational protocol as the forward span task, except that participants were required to reproduce the digits in reverse order. For the scoring rules, each correctly reproduced digit sequence

  6. Self-Care Abilities

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    Self-care abilities will be assessed using the Community COPD Self-Management Scale, a 39-item scale covering three domains: disease symptom management, lifestyle management, and psychosocial management. Total scores range from 39 to 195, with higher scores indicating better self-care abilities.

Secondary outcomes

  1. Physical Activity Levels

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    Physical activity levels will be assessed using the Chinese version of the Physical Activity Scale for the Elderly (PASE-C), which measures leisure time, household, and work-related physical activities over the past 7 days.

  2. Self-Efficacy

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    Self-efficacy will be assessed using the Chinese version of the Exercise Self-Regulatory Efficacy Scale (Ex-SRES-Chinese), a 16-item scale measuring participants' confidence in adhering to exercise. Total scores range from 0 to 160, with higher scores indicating higher exercise self-efficacy.

  3. Exercise Capacity

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    Exercise capacity will be assessed using the 6-minute walk test (6MWT), conducted in accordance with American Thoracic Society guidelines. The distance walked in 6 minutes (6MWD) will be recorded.

  4. Health-Related Quality of Life

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    Health-related quality of life will be assessed using the COPD Assessment Test (CAT), an 8-item questionnaire. Total scores range from 0 to 40, with higher scores indicating poorer quality of life.

  5. Anxiety Symptoms

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, a 7-item self-reported questionnaire. Total scores range from 0 to 21, with higher scores indicating more severe anxiety (0-4: minimal, 5-9: mild, 10-14: moderate, 15-21: severe).

  6. Depression Symptoms

    Time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)

    Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-reported questionnaire. Total scores range from 0 to 27, with higher scores indicating more severe depression (0-4: minimal, 5-9: mild, 10-14: moderate, 15-19: moderately severe, 20-27: severe).

Study contacts

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

Yi Nam Suen

CONTACT

[email protected]

+852 3917 6612

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Development and Evaluation of a Culturally Adapted Snacktivity™ Intervention to Enhance Cognition and Self-Care in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Acronym: Snacktivity™

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

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

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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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