Knee OsteoarthristisCHALAANENCT07786038
E-Health Lifestyle Intervention for Arthritis: A Pilot RCT on Feasibility
A study testing Digital Health Intervention and Inactivated Smartband for Activity Monitoring in people with Knee Osteoarthristis and Obesity & Overweight, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Knee osteoarthritis and obesity are common health problems in Hong Kong, especially among South Asian communities, where obesity rates are much higher than the general population. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthristis, Obesity & Overweight
- What is being tested?
- Digital Health Intervention and Inactivated Smartband for Activity Monitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Sep 2026to 31 May 2029
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- South Asian
- Men and women aged 40 to 75 years, with obesity (body mass index≥25 kg/m2, Hong Kong Centre for Health Protection obesity definition)
- Knee osteoarthritis (European League Against Rheumatism (EULAR) clinical criteria): age≥40 with movement-related joint pain, morning knee stiffness<30 min, and functional limitations, and crepitus/reduced range/bony enlargement)
- Pain less than 2 years
Who cannot join
- Unwillingness/inability to change eating/physical activity habits
- Severe knee OA daily resting pain (NPRS>8/10) or (Kellgren-Lawrence grade=4) that could not tolerate further conservative management
- inflammatory arthritis like rheumatoid arthritis, etc.
- Previous knee surgery
- immediate requirement for joint replacement, e.g. bone loss
- Planning to leave HK >2 months during the study period
Show all 9Show fewer
- cognitive impairment, vision and hearing impairment precluding use of Smartband+App
- losing/gaining >5% weight in 6months or on dieting
- high levels of psychological distress (Kessler 10 questionnaire-K10 score >29）
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong, Pofuklam, 999077
Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F, 92646862, laucml@hku.hk
The Duchess of Kent Children's Hospital at Sandy Bay
Hong Kong, Sandy Bay, 999077
Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F, 92646862, laucml@hku.hk
About this study
Official title: Community Healthy Asian Lifestyle for Ameliorating Arthritis With Navigational E-health: A Pilot Randomized Controlled Trial on Feasibility and Acceptability
Knee osteoarthritis and obesity are common health problems in Hong Kong, especially among South Asian communities, where obesity rates are much higher than the general population. These two conditions often make each other worse-pain from arthritis leads to less physical activity, which can lead to more weight gain and more joint pain.
This pilot study is testing a new digital health program called CHALAANE(Community health asian lifestyle for ameliorating arthritis with navigational e-health), which means "walk" in Hindi and Urdu. The program uses a smartband and a mobile app with artificial intelligence to help participants track their activity and diet. It also includes a 12-week supervised program with group walking sessions and lifestyle education.
Read more
The study will include 50 South Asian adults aged 40 to 75 years who have knee osteoarthritis and obesity. Participants will be randomly assigned to one of two groups. The intervention group will receive the full CHALAANE program with an activated smartband and mobile app. The control group will receive an inactivated smartband for activity monitoring only. The study will last 10 months, with assessments at multiple time points.
The main goal of this pilot study is to see if a larger future study would be feasible. The researchers will measure how many participants follow the program as instructed and how many complete the full 10-month study. They will also look at whether the program is acceptable to the South Asian community and gather early data on pain, physical function, and body composition.
The study is a collaboration between the Department of Orthopaedics \& Traumatology at Queen Mary Hospital and The Duchess of Kent Children's Hospital. A total of 50 participants will be recruited. Results will help inform the design of a future full-scale trial to improve health outcomes in this underserved population.
Read the detailed description
This is a single-center, prospective, double-blinded, pilot randomized controlled trial conducted at the Department of Orthopaedics \& Traumatology, Queen Mary Hospital (QMH) and The Duchess of Kent Children's Hospital (DKCH), Hong Kong. The study evaluates the feasibility and acceptability of a culturally tailored digital health intervention-CHALAANE (Community Healthy Asian Lifestyle for Ameliorating Arthritis with Navigational E-health)-for South Asian adults with knee osteoarthritis and obesity.
Intervention Components
The CHALAANE intervention consists of three integrated components:
Smartband Activity Monitoring: Participants in the intervention group receive an activated smartband that continuously tracks physical activity, including step count, distance, and active minutes. The control group receives an identical smartband that is inactivated (i.e., it collects no data and provides no feedback).
Mobile Application with AI Dietary Analysis: The intervention group uses a mobile application that incorporates artificial intelligence for dietary logging and analysis. The app provides personalized feedback on dietary intake, including calorie consumption and macronutrient composition, to support weight management goals.
Supervised Practicum: The intervention group participates in a 12-week supervised practicum consisting of weekly group sessions. These sessions include guided group walking activities and lifestyle education covering topics such as healthy eating, pain management, and behavior change strategies.
Randomization and Blinding Eligible participants will be randomized in a 1:1 ratio to either the intervention group (n=25) or the control group (n=25) using a computer-generated randomization sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The study is double-blinded: participants and outcome assessors will be blinded to group allocation. The intervention delivery team (who facilitate the practicum sessions) cannot be blinded due to the nature of the intervention.
Assessments and Follow-up Schedule
Participants will undergo comprehensive assessments at baseline and at 1, 4, 7, and 10 months post-randomization. Assessments include:
Functional Tests: Gait speed measured using the 10-meter walk test.
Patient-Reported Outcome Measures (PROMs): WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) for pain, stiffness, and physical function; EQ-5D-5L for health-related quality of life.
Body Composition: Measured using Bioelectrical Impedance Analysis (BIA) to assess fat mass, muscle mass, and body fat percentage.
Blood Tests: Inflammatory and metabolic biomarkers will be collected at baseline and 10 months.
Additionally, exit interviews will be conducted with a subset of participants to gather qualitative feedback on cultural acceptability, user experience, and barriers to engagement.
Primary and Secondary Outcomes The primary outcomes are feasibility metrics: (1) adherence rate, defined as the proportion of days participants use the smartband and mobile app as per protocol, and (2) follow-up rate, defined as the proportion of participants who complete the entire 10-month study. The success threshold for both is pre-defined as 70%.
Secondary outcomes include recruitment rate (number of participants enrolled per month), cultural acceptability (assessed via qualitative interviews and acceptability questionnaires), and preliminary clinical data on functional limitations (gait speed, WOMAC), pain (NRS), and body composition (BIA).
Study Duration The total study duration is 24 months, comprising a 10-month intervention period with assessments at multiple time points.
Sample Size A total of 50 participants will be recruited (25 per group). The sample size was determined based on feasibility considerations, budget constraints, and consultations with collaborating non-governmental organizations, confirming that approximately 25 participants per group is manageable given the intensive nature of the intervention.
Data Management and Monitoring All data will be collected on standardized case report forms and entered into a password-protected database. The study is overseen by the principal investigator (Prof. LAU Chun Man Lawrence). The study will be conducted in compliance with ICH-GCP guidelines and the Declaration of Helsinki. Serious adverse events will be reported to the HKU/HA HKW IRB within 24 hours. No interim analyses are planned.
- Conditions
- Knee Osteoarthristis, Obesity & Overweight
- Being tested
- Digital Health Intervention, Inactivated Smartband for Activity Monitoring
- Keywords
- Knee Osteoarthritis, Obesity, Digital Health, mHealth, Artificial Intelligence, Lifestyle Intervention
- Medical subject headings
- Obesity, Overweight, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health InterventionBehavioural
The CHALAANE intervention is a culturally tailored digital health program for South Asian adults with knee osteoarthritis and obesity. It consists of three integrated components: (1) an activated smartband that continuously tracks physical activity including step count, distance, and active minutes; (2) a mobile application with artificial intelligence for dietary logging and analysis, providing personalized feedback on calorie consumption and macronutrient composition; and (3) a 12-week supervised practicum with weekly group walking sessions and lifestyle education covering healthy eating, pain management, and behavior change strategies. The intervention period is 10 months.
Inactivated Smartband for Activity MonitoringDevice
Participants in the control group receive an identical smartband that is inactivated, meaning it collects no activity data and provides no feedback to the participant. This serves as a minimal intervention to control for the effect of wearing a device while not receiving the active components of the CHALAANE program (AI dietary analysis, supervised practicum, and lifestyle education).
| Study group | Role | What they receive |
|---|---|---|
| CHALAANE Program | Experimental | Participants in this arm receive the full CHALAANE digital health intervention. They will use an activated smartband to monitor physical activity, a mobile application with artificial intelligence for dietary analysis and personalized feedback, and participate in a 12-week supervised practicum consisting of weekly group walking sessions and lifestyle education on healthy eating, pain management, and behavior change strategies. The intervention period is 10 months with assessments at baseline, 1, 4, 7, and 10 months. Receives: Behavioral: Digital Health Intervention |
| Inactivated Smartband Only | Active comparator | Participants in this arm receive an inactivated smartband for activity monitoring only. No feedback is provided, and participants do not receive access to the mobile application or the supervised practicum sessions. All other study procedures, including assessments and follow-up schedule, are identical to the intervention group. Assessments are conducted at baseline, 1, 4, 7, and 10 months. Receives: Device: Inactivated Smartband for Activity Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence and follow-up rate
Adherence rate is defined as the proportion of participants following the study protocol:
Using the smartband with Smartband+App and using Smartband+App on> 70% of days are the predefined outcomes for adherence. Research Assistant/social worker will meet weekly with participants in both groups till study-end due to potential technological unfamiliarity of South Asians to troubleshoot usage problems, retrieve data simultaneously, and avoid misusing the smartband. This shall have the highest guarantee of adherence accuracy.
Follow-up rate is defined is proportion of participants completing the study at 10 months (study end), with ≥ 70% as the predefined outcome.
Achieving ≥ 70% for both rates is a predefined outcome that would enable scale-up to a larger project. Participants are free to drop out at any time point.
Measured: 10 months (calculated at study end)
Intervention program and assessment acceptability
Acceptability was measured by the Client Satisfaction Questionnaire (CSQ) post-treatment as in similar OA programs (38). The CSQ is commonly used in treatment acceptability studies and includes items such as "How satisfied are you with the amount of help you received?" and "To what degree did the program teach you skills that are helping you to better manage your symptoms?" rated on a Likert scale. The assessment acceptability is also quantitatively assessed by a 5-point Likert questionnaire. ≥70% of participants rating the intervention and assessment as "acceptable" (i.e.,≥4/5 on the Likert scale) as the predefined threshold. Semi-structured interviews at study end will be conducted to capture feedback qualitatively
Measured: 10 months (calculated at study end)
Recruitment rate
Ratio between the number of eligible participants recruited and the duration of recruitment period (per month). This will help estimate the recruitment time required for full trial.
Measured: 12 months (throughout recruitment period)
Secondary outcomes (19)
Performance-Based Functional Limitation Assessed by Gait Speed
Gait speed will be measured using the 6-metre walk test. Participants will be instructed to walk at their usual pace over a 6-metre course, and the faster of two trials will be recorded in metres per second (m/s). A gait speed of less than 1.0 m/s is defined as the threshold for persistent limitations in functioning and mortality, based on previous studies.
Measured: Measurement at baseline, 1month 4 months, 7months and 10months
Self-Reported Functional Limitation Assessed by Western Ontario and McMaster Universities Osteoarthritis Index Physical Function Subscale
Physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscale. This subscale consists of 17 items assessing difficulty experienced during daily activities such as walking, stair climbing, and rising from a seated position. Each item is scored on a 0-4 Likert scale (0 = none, 4 = extreme), with a total subscale score ranging from 0 to 68 (higher scores indicating worse physical function). A score of 28 or above (≥28/68) is defined as poor functional outcome in previous studies.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Pain Intensity Assessed by the Numerical Pain Rating Scale
Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate their current knee pain intensity. The NPRS is a validated and widely used instrument for assessing pain in patients with knee osteoarthritis.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Pain Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale
Pain will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. This subscale consists of 5 items assessing pain experienced during activities such as walking, using stairs, and resting. Each item is scored on a 0-4 Likert scale (0 = none, 4 = extreme), with a total subscale score ranging from 0 to 20 (higher scores indicating worse pain). The WOMAC pain subscale is a validated and widely used instrument in knee osteoarthritis research.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Stiffness Assessment Using the Western Ontario and McMaster Universities Osteoarthritis Index Stiffness Subscale
Stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale. This subscale consists of 2 items measuring the severity of joint stiffness experienced upon waking in the morning and later in the day. Each item is scored on a 0-4 Likert scale (0 = none, 4 = extreme), with a total subscale score ranging from 0 to 8 (higher scores indicating worse stiffness). The WOMAC stiffness subscale is a validated and widely used instrument in knee osteoarthritis research.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Blood Lipid Profile Assessment
Fasting blood samples will be collected to assess lipid profile parameters, including triglycerides (mmol/L), total cholesterol (mmol/L), low-density lipoprotein cholesterol (LDL-C, mmol/L), and high-density lipoprotein cholesterol (HDL-C, mmol/L). All blood samples will be collected following an overnight fast and processed according to standard laboratory protocols.
Measured: Baseline and 4 months
Blood Glucose Metabolism Markers Assessment
Fasting blood samples will be collected to assess glucose metabolism parameters, including fasting glucose (mmol/L), HbA1c (%), and C-peptide (nmol/L). All blood samples will be collected following an overnight fast and processed according to standard laboratory protocols. These markers provide objective measures of glycemic control and insulin secretion.
Measured: Baseline and 4 months
Blood Inflammatory and Endothelial Biomarkers Assessment
Fasting blood samples will be collected to assess inflammatory and endothelial biomarkers, including leptin (ng/mL), E-selectin (ng/mL), P-selectin (ng/mL), interleukin-6 (IL-6, pg/mL), and interleukin-8 (IL-8, pg/mL). These biomarkers provide objective measures of systemic inflammation and endothelial activation, which are relevant to both obesity and knee osteoarthritis pathophysiology. All blood samples will be collected following an overnight fast and processed according to standard laboratory protocols.
Measured: Baseline and 4 months
Body Mass Index (BMI)
Body mass index (BMI) will be calculated from measured weight and height using the formula: weight (kg) divided by height squared (m²). Weight will be measured using a calibrated scale, and height will be measured using a stadiometer. BMI will be reported in kg/m² and used as an objective indicator of obesity and overall health.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Waist Circumference
Waist circumference (cm) will be measured using a non-elastic tape measure following standardized protocols. The measurement will be taken at the midpoint between the lower rib margin and the iliac crest at the end of normal expiration. Waist circumference is an objective indicator of central obesity and metabolic risk.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Calf Circumference
Calf circumference (cm) will be measured using a non-elastic tape measure following standardized protocols. The measurement will be taken at the maximum circumference of the calf on both legs. Calf circumference is an indicator of skeletal muscle mass and nutritional status.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Blood Pressure
Blood pressure (systolic and diastolic, mmHg) will be measured using an automated sphygmomanometer after the participant has rested for at least 5 minutes. Blood pressure is an important indicator of cardiovascular health.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Appendicular Skeletal Muscle Mass
Appendicular Skeletal Muscle Mass (ASM, kg) will be assessed using Bioelectrical Impedance Analysis (BIA), a non-invasive and validated method for estimating body composition. BIA measurements will be performed following standardized protocols, with participants in a fasting state and having emptied their bladder. ASM is an important indicator of sarcopenia and muscle health.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Body Fat Percentage
Body fat percentage (%) will be assessed using Bioelectrical Impedance Analysis (BIA), a non-invasive and validated method for estimating body composition. BIA measurements will be performed following standardized protocols, with participants in a fasting state and having emptied their bladder. Body fat percentage is an important indicator of obesity and metabolic health.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Visceral Fat Percentage
Visceral fat percentage (%) will be assessed using Bioelectrical Impedance Analysis (BIA), a non-invasive and validated method for estimating body composition. BIA measurements will be performed following standardized protocols, with participants in a fasting state and having emptied their bladder. Visceral fat percentage is an important indicator of central obesity and cardiometabolic risk.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Handgrip Strength
Handgrip strength (kg) will be measured using a Jamar hydraulic dynamometer, a validated and reliable instrument for assessing upper extremity muscle strength. Participants will be seated with their shoulder adducted and neutrally rotated, elbow flexed at 90 degrees, and wrist in a neutral position. The test will be performed three times on each hand, with the maximum value recorded. Handgrip strength is a reliable indicator of overall muscle strength and has been shown to correlate with functional outcomes and nutritional status.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Gait Speed
Gait speed (m/s) will be measured using the 6-metre walk test. Participants will be instructed to walk at their usual pace over a 6-metre course, and the faster of two trials will be recorded. Gait speed is a reliable and validated measure of physical function and is predictive of adverse outcomes in older adult populations.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
5-Time Chair Stand Test
Lower extremity strength and function will be assessed using the 5-time chair stand test. Participants will be asked to stand up and sit down from a standard chair five times as quickly as possible with their arms folded across their chest. The time taken to complete five stands will be recorded in seconds. This test is widely used and validated in older adult populations with osteoarthritis.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Short Physical Performance Battery
Physical function will be assessed using the Short Physical Performance Battery (SPPB), which combines three tests: standing balance, gait speed (6-metre walk), and the 5-time chair stand test. Each component is scored from 0 to 4, yielding a total score ranging from 0 to 12 (higher scores indicating better physical function). The SPPB is a validated and widely used measure of lower extremity function in older adults.
Measured: Baseline, 1 month, 4 months, 7 months, and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Lawrence Lau, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786038
- Sponsor's protocol ID
- UW 25-563
- Acronym
- CHALAANE
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers due to institutional data protection policies, patient confidentiality requirements, and the absence of a data sharing agreement in the study protocol. Access to study data will be restricted to the principal investigator and designated study team members for the purposes of data analysis and publication. All data will be stored in a password-protected computer and retained for 5 years after study completion, after which it will be destroyed in accordance with the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Healthy Asian Lifestyle for Ameliorating Arthritis With Navigational E-health: A Pilot Randomized Controlled Trial on Feasibility and Acceptability
- ClinicalTrials.gov ID
- NCT07786038
- Acronym / sponsor ID
- CHALAANE / UW 25-563
- Conditions
- Knee Osteoarthristis, Obesity & Overweight
- Keywords
- Knee Osteoarthritis, Obesity, Digital Health, mHealth, Artificial Intelligence, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee osteoarthritis and obesity are common health problems in Hong Kong, especially among South Asian communities, where obesity rates are much higher than the general population. These two conditions often make each other worse-pain from arthritis leads to less physical activity, which can lead to more weight gain and more joint pain.
This pilot study is testing a new digital health program called CHALAANE(Community health asian lifestyle for ameliorating arthritis with navigational e-health), which means "walk" in Hindi and Urdu. The program uses a smartband and a mobile app with artificial intelligence to help participants track their activity and diet. It also includes a 12-week supervised program with group walking sessions and lifestyle education.
The study will include 50 South Asian adults aged 40 to 75 years who have knee osteoarthritis and obesity. Participants will be randomly assigned to one of two groups. The intervention group will receive the full CHALAANE program with an activated smartband and mobile app. The control group will receive an inactivated smartband for activity monitoring only. The study will last 10 months, with assessments at multiple time points.
The main goal of this pilot study is to see if a larger future study would be feasible. The researchers will measure how many participants follow the program as instructed and how many complete the full 10-month study. They will also look at whether the program is acceptable to the South Asian community and gather early data on pain, physical function, and body composition.
The study is a collaboration between the Department of Orthopaedics \& Traumatology at Queen Mary Hospital and The Duchess of Kent Children's Hospital. A total of 50 participants will be recruited. Results will help inform the design of a future full-scale trial to improve health outcomes in this underserved population.
Detailed description
This is a single-center, prospective, double-blinded, pilot randomized controlled trial conducted at the Department of Orthopaedics \& Traumatology, Queen Mary Hospital (QMH) and The Duchess of Kent Children's Hospital (DKCH), Hong Kong. The study evaluates the feasibility and acceptability of a culturally tailored digital health intervention-CHALAANE (Community Healthy Asian Lifestyle for Ameliorating Arthritis with Navigational E-health)-for South Asian adults with knee osteoarthritis and obesity.
Intervention Components
The CHALAANE intervention consists of three integrated components:
Smartband Activity Monitoring: Participants in the intervention group receive an activated smartband that continuously tracks physical activity, including step count, distance, and active minutes. The control group receives an identical smartband that is inactivated (i.e., it collects no data and provides no feedback).
Mobile Application with AI Dietary Analysis: The intervention group uses a mobile application that incorporates artificial intelligence for dietary logging and analysis. The app provides personalized feedback on dietary intake, including calorie consumption and macronutrient composition, to support weight management goals.
Supervised Practicum: The intervention group participates in a 12-week supervised practicum consisting of weekly group sessions. These sessions include guided group walking activities and lifestyle education covering topics such as healthy eating, pain management, and behavior change strategies.
Randomization and Blinding Eligible participants will be randomized in a 1:1 ratio to either the intervention group (n=25) or the control group (n=25) using a computer-generated randomization sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The study is double-blinded: participants and outcome assessors will be blinded to group allocation. The intervention delivery team (who facilitate the practicum sessions) cannot be blinded due to the nature of the intervention.
Assessments and Follow-up Schedule
Participants will undergo comprehensive assessments at baseline and at 1, 4, 7, and 10 months post-randomization. Assessments include:
Functional Tests: Gait speed measured using the 10-meter walk test.
Patient-Reported Outcome Measures (PROMs): WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) for pain, stiffness, and physical function; EQ-5D-5L for health-related quality of life.
Body Composition: Measured using Bioelectrical Impedance Analysis (BIA) to assess fat mass, muscle mass, and body fat percentage.
Blood Tests: Inflammatory and metabolic biomarkers will be collected at baseline and 10 months.
Additionally, exit interviews will be conducted with a subset of participants to gather qualitative feedback on cultural acceptability, user experience, and barriers to engagement.
Primary and Secondary Outcomes The primary outcomes are feasibility metrics: (1) adherence rate, defined as the proportion of days participants use the smartband and mobile app as per protocol, and (2) follow-up rate, defined as the proportion of participants who complete the entire 10-month study. The success threshold for both is pre-defined as 70%.
Secondary outcomes include recruitment rate (number of participants enrolled per month), cultural acceptability (assessed via qualitative interviews and acceptability questionnaires), and preliminary clinical data on functional limitations (gait speed, WOMAC), pain (NRS), and body composition (BIA).
Study Duration The total study duration is 24 months, comprising a 10-month intervention period with assessments at multiple time points.
Sample Size A total of 50 participants will be recruited (25 per group). The sample size was determined based on feasibility considerations, budget constraints, and consultations with collaborating non-governmental organizations, confirming that approximately 25 participants per group is manageable given the intensive nature of the intervention.
Data Management and Monitoring All data will be collected on standardized case report forms and entered into a password-protected database. The study is overseen by the principal investigator (Prof. LAU Chun Man Lawrence). The study will be conducted in compliance with ICH-GCP guidelines and the Declaration of Helsinki. Serious adverse events will be reported to the HKU/HA HKW IRB within 24 hours. No interim analyses are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHALAANE Program | Experimental | Behavioral: Digital Health InterventionParticipants in this arm receive the full CHALAANE digital health intervention. They will use an activated smartband to monitor physical activity, a mobile application with artificial intelligence for dietary analysis and personalized feedback, and participate in a 12-week supervised practicum consisting of weekly group walking sessions and lifestyle education on healthy eating, pain management, and behavior change strategies. The intervention period is 10 months with assessments at baseline, 1, 4, 7, and 10 months. |
| Inactivated Smartband Only | Active comparator | Device: Inactivated Smartband for Activity MonitoringParticipants in this arm receive an inactivated smartband for activity monitoring only. No feedback is provided, and participants do not receive access to the mobile application or the supervised practicum sessions. All other study procedures, including assessments and follow-up schedule, are identical to the intervention group. Assessments are conducted at baseline, 1, 4, 7, and 10 months. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (9 listed)
- Unwillingness/inability to change eating/physical activity habits
- Severe knee OA daily resting pain (NPRS>8/10) or (Kellgren-Lawrence grade=4) that could not tolerate further conservative management
- inflammatory arthritis like rheumatoid arthritis, etc.
- Previous knee surgery
- immediate requirement for joint replacement, e.g. bone loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health InterventionThe CHALAANE intervention is a culturally tailored digital health program for South Asian adults with knee osteoarthritis and obesity. It consists of three integrated components: (1) an activated smartband that continuously tracks physical activity including step count, distance, and active minutes; (2) a mobile application with artificial intelligence for dietary logging and analysis, providing personalized feedback on calorie consumption and macronutrient composition; and (3) a 12-week supervised practicum with weekly group walking sessions and lifestyle education covering healthy eating, pain management, and behavior change strategies. The intervention period is 10 months. | Behavioural | CHALAANE Program |
| Inactivated Smartband for Activity MonitoringParticipants in the control group receive an identical smartband that is inactivated, meaning it collects no activity data and provides no feedback to the participant. This serves as a minimal intervention to control for the effect of wearing a device while not receiving the active components of the CHALAANE program (AI dietary analysis, supervised practicum, and lifestyle education). | Device | Inactivated Smartband Only |
Primary outcome
Adherence and follow-up rate
Time frame: 10 months (calculated at study end)
Adherence rate is defined as the proportion of participants following the study protocol: Using the smartband with Smartband+App and using Smartband+App on> 70% of days are the predefined outcomes for adherence. Research Assistant/social worker will meet weekly with participants in both groups till study-end due to potential technological unfamiliarity of South Asians to troubleshoot usage problems, retrieve data simultaneously, and avoid misusing the smartband. This shall have the highest guarantee of adherence accuracy. Follow-up rate is defined is proportion of participants completing the study at 10 months (study end), with ≥ 70% as the predefined outcome. Achieving ≥ 70% for both rates is a predefined outcome that would enable scale-up to a larger project. Participants are free to drop out at any time point.
Intervention program and assessment acceptability
Time frame: 10 months (calculated at study end)
Acceptability was measured by the Client Satisfaction Questionnaire (CSQ) post-treatment as in similar OA programs (38). The CSQ is commonly used in treatment acceptability studies and includes items such as "How satisfied are you with the amount of help you received?" and "To what degree did the program teach you skills that are helping you to better manage your symptoms?" rated on a Likert scale. The assessment acceptability is also quantitatively assessed by a 5-point Likert questionnaire. ≥70% of participants rating the intervention and assessment as "acceptable" (i.e.,≥4/5 on the Likert scale) as the predefined threshold. Semi-structured interviews at study end will be conducted to capture feedback qualitatively
Recruitment rate
Time frame: 12 months (throughout recruitment period)
Ratio between the number of eligible participants recruited and the duration of recruitment period (per month). This will help estimate the recruitment time required for full trial.
19 secondary outcomes
Performance-Based Functional Limitation Assessed by Gait Speed
Time frame: Measurement at baseline, 1month 4 months, 7months and 10months
Self-Reported Functional Limitation Assessed by Western Ontario and McMaster Universities Osteoarthritis Index Physical Function Subscale
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Pain Intensity Assessed by the Numerical Pain Rating Scale
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Pain Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Stiffness Assessment Using the Western Ontario and McMaster Universities Osteoarthritis Index Stiffness Subscale
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Blood Lipid Profile Assessment
Time frame: Baseline and 4 months
Blood Glucose Metabolism Markers Assessment
Time frame: Baseline and 4 months
Blood Inflammatory and Endothelial Biomarkers Assessment
Time frame: Baseline and 4 months
Body Mass Index (BMI)
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Waist Circumference
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Calf Circumference
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Blood Pressure
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Appendicular Skeletal Muscle Mass
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Body Fat Percentage
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Visceral Fat Percentage
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Handgrip Strength
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Gait Speed
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
5-Time Chair Stand Test
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Short Physical Performance Battery
Time frame: Baseline, 1 month, 4 months, 7 months, and 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers due to institutional data protection policies, patient confidentiality requirements, and the absence of a data sharing agreement in the study protocol. Access to study data will be restricted to the principal investigator and designated study team members for the purposes of data analysis and publication. All data will be stored in a password-protected computer and retained for 5 years after study completion, after which it will be destroyed in accordance with the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Intervention and Inactivated Smartband for Activity Monitoring in people with Knee Osteoarthristis and Obesity & Overweight, run by The University of Hong Kong at 2 sites in 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 4 inclusion and 9 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F (92646862, laucml@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence and follow-up rate (time frame: 10 months (calculated at study end)). The study lists 3 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 25 Aug 2026.