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

NCT07702994 | Not Yet Recruiting

• 2 other identifiers: UW 26-042RG2025/2026_A_05
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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

Conditions

COPD; Physical Activity; Cognition; Self Care

Keywords

COPD; cognitive function; self care

Outcome Measures

Primary Outcomes (6)

• 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.

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

• 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

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

• 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.

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

• 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.

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

• 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

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

• 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.

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

Secondary Outcomes (6)

• Physical Activity Levels

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

• Self-Efficacy

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

• Exercise Capacity

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

• Health-Related Quality of Life

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

• Anxiety Symptoms

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

Study Arms (2)

Snacktivity™ Intervention Group

EXPERIMENTAL

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.

Behavioral: Snacktivity™ Intervention

Attention Control Group

ACTIVE COMPARATOR

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.

Behavioral: attention control

Interventions

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.

Snacktivity™ Intervention Group

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.

Attention Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Yi Nam Suen

CONTACT

+852 3917 6612; suenyn@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is single-blinded. The outcomes assessor is masked to group allocation throughout the study. Participants are aware of their group assignment, and intervention providers (researchers delivering the Snacktivity™ program or attention control sessions) are not masked due to the nature of the behavioral intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share