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

This is a single‐center, prospective, double‐blinded, pilot randomized controlled trialconducted at the Department of Orthopaedics & Traumatology, Queen Mary Hospital (QMH) andThe Duchess of Kent Children's Hospital (DKCH), Hong Kong. The study evaluates thefeasibility and acceptability of a culturally tailored digital healthintervention‐CHALAANE (Community Healthy Asian Lifestyle for Ameliorating Arthritis withNavigational E‐health)‐for South Asian adults with knee osteoarthritis and obesity.Intervention ComponentsThe CHALAANE intervention consists of three integrated components:Smartband Activity Monitoring: Participants in the intervention group receive anactivated smartband that continuously tracks physical activity, including step count,distance, and active minutes. The control group receives an identical smartband that isinactivated (i.e., it collects no data and provides no feedback).Mobile Application with AI Dietary Analysis: The intervention group uses a mobileapplication that incorporates artificial intelligence for dietary logging and analysis.The app provides personalized feedback on dietary intake, including calorie consumptionand macronutrient composition, to support weight management goals.Supervised Practicum: The intervention group participates in a 12‐week supervisedpracticum consisting of weekly group sessions. These sessions include guided groupwalking activities and lifestyle education covering topics such as healthy eating, painmanagement, and behavior change strategies.Randomization and Blinding Eligible participants will be randomized in a 1:1 ratio toeither the intervention group (n=25) or the control group (n=25) using acomputer‐generated randomization sequence. Allocation concealment will be maintainedusing sequentially numbered, opaque, sealed envelopes. The study is double‐blinded:participants and outcome assessors will be blinded to group allocation. The interventiondelivery team (who facilitate the practicum sessions) cannot be blinded due to the natureof the intervention.Assessments and Follow‐up ScheduleParticipants will undergo comprehensive assessments at baseline and at 1, 4, 7, and 10months post‐randomization. Assessments include:Functional Tests: Gait speed measured using the 10‐meter walk test.Patient‐Reported Outcome Measures (PROMs): WOMAC (Western Ontario and McMasterUniversities Osteoarthritis Index) for pain, stiffness, and physical function; EQ‐5D‐5Lfor health‐related quality of life.Body Composition: Measured using Bioelectrical Impedance Analysis (BIA) to assess fatmass, muscle mass, and body fat percentage.Blood Tests: Inflammatory and metabolic biomarkers will be collected at baseline and 10months.Additionally, exit interviews will be conducted with a subset of participants to gatherqualitative feedback on cultural acceptability, user experience, and barriers toengagement.Primary and Secondary Outcomes The primary outcomes are feasibility metrics: (1)adherence rate, defined as the proportion of days participants use the smartband andmobile app as per protocol, and (2) follow‐up rate, defined as the proportion ofparticipants who complete the entire 10‐month study. The success threshold for both ispre‐defined as 70%.Secondary outcomes include recruitment rate (number of participants enrolled per month),cultural acceptability (assessed via qualitative interviews and acceptabilityquestionnaires), 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 interventionperiod with assessments at multiple time points.Sample Size A total of 50 participants will be recruited (25 per group). The sample sizewas determined based on feasibility considerations, budget constraints, and consultationswith collaborating non‐governmental organizations, confirming that approximately 25participants per group is manageable given the intensive nature of the intervention.Data Management and Monitoring All data will be collected on standardized case reportforms and entered into a password‐protected database. The study is overseen by theprincipal investigator (Prof. LAU Chun Man Lawrence). The study will be conducted incompliance with ICH‐GCP guidelines and the Declaration of Helsinki. Serious adverseevents will be reported to the HKU/HA HKW IRB within 24 hours. No interim analyses areplanned.