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COPDSnacktivity™NCT07702994

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

A study testing Snacktivity™ Intervention in people with COPD and Physical Activity, run by The University of Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
COPD, Physical Activity, Cognition
What is being tested?
Snacktivity™ Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
No sites listed yet
Study dates
15 Jul 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yi Nam Suen contact

+852 3917 6612

suenyn@hku.hk

About this study

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

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:

Read more
  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.

Read the detailed description
  1. 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:

  1. 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.
  2. 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).
  3. 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.

  1. 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).
  2. 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:
  3. 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.
  4. Self-care abilities, assessed by the Community COPD Self-Management Scale.
  5. Physical activity levels, assessed by the Physical Activity Scale for the Elderly-Chinese version (PASE-C).
  6. Self-efficacy, assessed by the Exercise Self-Regulatory Efficacy Scale-Chinese version (Ex-SRES-Chinese).
  7. Exercise capacity, assessed by the 6-minute walk test (6MWT).
  8. Health-related quality of life, assessed by the COPD Assessment Test (CAT).
  9. Anxiety, assessed by the Generalised Anxiety Disorder-7 (GAD-7) scale.
  10. Depression, assessed by the Patient Health Questionnaire-9 (PHQ-9)
  11. 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.
  12. Hypotheses:
  13. The culturally adapted Snacktivity™ program will demonstrate high feasibility among COPD patients in Hong Kong.
  14. 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.
  15. The culturally adapted Snacktivity™ intervention program will exhibit overall effectiveness and sustainable implementability among COPD patients in Hong Kong.
Being tested
Snacktivity™ Intervention, attention control
Keywords
COPD, cognitive function, self care
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Snacktivity™ InterventionBehavioural

    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 controlBehavioural

    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.

Study groups in NCT07702994
Study groupRoleWhat they receive
Snacktivity™ Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Snacktivity™ Intervention
Attention Control GroupActive comparatorParticipants 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.
Receives: Behavioral: attention control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global cognition

    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.

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

  2. Memory

    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

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

  3. Language

    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.

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

  4. Executive function

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

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

  5. Attention

    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

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

  6. Self-Care Abilities

    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.

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

Secondary outcomes (6)
  1. Physical Activity Levels

    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.

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

  2. Self-Efficacy

    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.

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

  3. Exercise Capacity

    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.

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

  4. Health-Related Quality of Life

    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.

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

  5. Anxiety Symptoms

    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).

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

  6. Depression Symptoms

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of two parallel groups: the Snacktivity™ intervention group or the attention control group. Both groups will be followed concurrently for 12 weeks.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07702994
Sponsor's protocol ID
UW 26-042
Other IDs
RG2025/2026_A_05
Acronym
Snacktivity™
Status last verified
Jul 2026
First submitted
30 Jun 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared as this is a doctoral student-led study conducted as part of a PhD project. The research team does not have the resources or infrastructure to support data sharing at this time. Data access is restricted to the study team to ensure participant confidentiality and protect the privacy of study participants.

Questions about this trial

What is this clinical trial studying?

A study testing Snacktivity™ Intervention in people with COPD and Physical Activity, run by The University of 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 10 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi Nam Suen (+852 3917 6612, suenyn@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global cognition (time frame: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Jul 2026.

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