E-Health Lifestyle Intervention for Arthritis: A Pilot RCT on Feasibility

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.

• Digital Health Intervention (Behavioral): 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 Monitoring (Device): 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).

Primary outcomes

• Adherence and follow-up rate [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 [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 [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.

Secondary outcomes

• Performance-Based Functional Limitation Assessed by Gait Speed [Measurement at baseline, 1month 4 months, 7months and 10months]: 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.
• Self-Reported Functional Limitation Assessed by Western Ontario and McMaster Universities Osteoarthritis Index Physical Function Subscale [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Pain Intensity Assessed by the Numerical Pain Rating Scale [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Pain Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Stiffness Assessment Using the Western Ontario and McMaster Universities Osteoarthritis Index Stiffness Subscale [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Blood Lipid Profile Assessment [Baseline and 4 months]: 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.
• Blood Glucose Metabolism Markers Assessment [Baseline and 4 months]: 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.
• Blood Inflammatory and Endothelial Biomarkers Assessment [Baseline and 4 months]: 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.
• Body Mass Index (BMI) [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Waist Circumference [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Calf Circumference [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Blood Pressure [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Appendicular Skeletal Muscle Mass [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Body Fat Percentage [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Visceral Fat Percentage [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Handgrip Strength [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Gait Speed [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• 5-Time Chair Stand Test [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.
• Short Physical Performance Battery [Baseline, 1 month, 4 months, 7 months, and 10 months]: 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.

Sex: All, ages: 40 Years to 75 Years

Inclusion Criteria:

* Inclusion criteria:

  1. South Asian
  2. Men and women aged 40 to 75 years, with obesity (body mass index≥25 kg/m2, Hong Kong Centre for Health Protection obesity definition)
  3. 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)
  4. Pain less than 2 years

Exclusion Criteria:

1. Unwillingness/inability to change eating/physical activity habits
2. Severe knee OA daily resting pain (NPRS>8/10) or (Kellgren-Lawrence grade=4) that could not tolerate further conservative management
3. inflammatory arthritis like rheumatoid arthritis, etc.
4. Previous knee surgery
5. immediate requirement for joint replacement, e.g. bone loss
6. Planning to leave HK >2 months during the study period
7. cognitive impairment, vision and hearing impairment precluding use of Smartband+App
8. losing/gaining >5% weight in 6months or on dieting
9. high levels of psychological distress (Kessler 10 questionnaire-K10 score >29）