[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653195":3},{"organization":4,"outcomesModule":7,"designInfo":82,"detailedDescription":92,"studyPopulation":81,"armGroups":93,"interventions":106,"overallOfficials":81,"centralContacts":117,"locations":127,"responsibleParty":150,"collaborators":81,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":156,"sex":162,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":81,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":182,"whyStopped":81,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":81},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Adherence and follow-up rate","Adherence rate is defined as the proportion of participants following the study protocol:\n\nUsing the smartband with Smartband+App and using Smartband+App on\\> 70% of days are the predefined outcomes for adherence. Research Assistant\u002Fsocial 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.\n\nFollow-up rate is defined is proportion of participants completing the study at 10 months (study end), with ≥ 70% as the predefined outcome.\n\nAchieving ≥ 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.","10 months (calculated at study end)",{"measure":14,"description":15,"timeFrame":12},"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\u002F5 on the Likert scale) as the predefined threshold. Semi-structured interviews at study end will be conducted to capture feedback qualitatively",{"measure":17,"description":18,"timeFrame":19},"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.","12 months (throughout recruitment period)",[21,25,29,32,35,38,42,45,48,51,54,57,60,63,66,69,72,75,78],{"measure":22,"description":23,"timeFrame":24},"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\u002Fs). A gait speed of less than 1.0 m\u002Fs is defined as the threshold for persistent limitations in functioning and mortality, based on previous studies.","Measurement at baseline, 1month 4 months, 7months and 10months",{"measure":26,"description":27,"timeFrame":28},"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\u002F68) is defined as poor functional outcome in previous studies.","Baseline, 1 month, 4 months, 7 months, and 10 months",{"measure":30,"description":31,"timeFrame":28},"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.",{"measure":33,"description":34,"timeFrame":28},"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.",{"measure":36,"description":37,"timeFrame":28},"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.",{"measure":39,"description":40,"timeFrame":41},"Blood Lipid Profile Assessment","Fasting blood samples will be collected to assess lipid profile parameters, including triglycerides (mmol\u002FL), total cholesterol (mmol\u002FL), low-density lipoprotein cholesterol (LDL-C, mmol\u002FL), and high-density lipoprotein cholesterol (HDL-C, mmol\u002FL). All blood samples will be collected following an overnight fast and processed according to standard laboratory protocols.","Baseline and 4 months",{"measure":43,"description":44,"timeFrame":41},"Blood Glucose Metabolism Markers Assessment","Fasting blood samples will be collected to assess glucose metabolism parameters, including fasting glucose (mmol\u002FL), HbA1c (%), and C-peptide (nmol\u002FL). 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.",{"measure":46,"description":47,"timeFrame":41},"Blood Inflammatory and Endothelial Biomarkers Assessment","Fasting blood samples will be collected to assess inflammatory and endothelial biomarkers, including leptin (ng\u002FmL), E-selectin (ng\u002FmL), P-selectin (ng\u002FmL), interleukin-6 (IL-6, pg\u002FmL), and interleukin-8 (IL-8, pg\u002FmL). 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.",{"measure":49,"description":50,"timeFrame":28},"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\u002Fm² and used as an objective indicator of obesity and overall health.",{"measure":52,"description":53,"timeFrame":28},"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.",{"measure":55,"description":56,"timeFrame":28},"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.",{"measure":58,"description":59,"timeFrame":28},"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.",{"measure":61,"description":62,"timeFrame":28},"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.",{"measure":64,"description":65,"timeFrame":28},"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.",{"measure":67,"description":68,"timeFrame":28},"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.",{"measure":70,"description":71,"timeFrame":28},"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.",{"measure":73,"description":74,"timeFrame":28},"Gait Speed","Gait speed (m\u002Fs) 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.",{"measure":76,"description":77,"timeFrame":28},"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.",{"measure":79,"description":80,"timeFrame":28},"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.",null,{"allocation":83,"interventionModel":84,"interventionModelDescription":81,"primaryPurpose":85,"observationalModel":81,"timePerspective":81,"maskingInfo":86},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":87,"maskingDescription":88,"whoMasked":89},"DOUBLE","Participants and outcomes assessors are blinded to group allocation. The intervention delivery team cannot be blinded due to the nature of the supervised practicum sessions, as they facilitate the group walking and lifestyle education activities. The allocation sequence is concealed using sequentially numbered, opaque, sealed envelopes. Investigators responsible for data analysis will receive de-identified data with group codes that are not unblinded until the final analysis is completed.",[90,91],"PARTICIPANT","OUTCOMES_ASSESSOR","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.\n\nIntervention Components\n\nThe CHALAANE intervention consists of three integrated components:\n\nSmartband 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).\n\nMobile 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.\n\nSupervised 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.\n\nRandomization 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.\n\nAssessments and Follow-up Schedule\n\nParticipants will undergo comprehensive assessments at baseline and at 1, 4, 7, and 10 months post-randomization. Assessments include:\n\nFunctional Tests: Gait speed measured using the 10-meter walk test.\n\nPatient-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.\n\nBody Composition: Measured using Bioelectrical Impedance Analysis (BIA) to assess fat mass, muscle mass, and body fat percentage.\n\nBlood Tests: Inflammatory and metabolic biomarkers will be collected at baseline and 10 months.\n\nAdditionally, exit interviews will be conducted with a subset of participants to gather qualitative feedback on cultural acceptability, user experience, and barriers to engagement.\n\nPrimary 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%.\n\nSecondary 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).\n\nStudy Duration The total study duration is 24 months, comprising a 10-month intervention period with assessments at multiple time points.\n\nSample 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.\n\nData 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\u002FHA HKW IRB within 24 hours. No interim analyses are planned.",[94,100],{"label":95,"type":96,"description":97,"interventionNames":98},"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.",[99],"Behavioral: Digital Health Intervention",{"label":101,"type":102,"description":103,"interventionNames":104},"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.",[105],"Device: Inactivated Smartband for Activity Monitoring",[107,112],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":81},"BEHAVIORAL","Digital Health Intervention","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.",[95],{"type":113,"name":114,"description":115,"armGroupLabels":116,"otherNames":81},"DEVICE","Inactivated Smartband for Activity Monitoring","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).",[101],[118,123],{"name":119,"role":120,"phone":121,"phoneExt":81,"email":122},"Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F","CONTACT","92646862","laucml@hku.hk",{"name":124,"role":120,"phone":125,"phoneExt":81,"email":126},"Kejing Eunice Ms. Xiao, Master","54845721","eunice7@hku.hk",[128,142],{"facility":129,"status":81,"city":130,"state":131,"zip":132,"country":130,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":139,"contacts":140},"Queen Mary Hospital","Hong Kong","Pofuklam","999077","HK",{"type":135,"coordinates":136},"Point",[137,138],114.17469,22.27832,{"lat":138,"lon":137},[141],{"name":119,"role":120,"phone":121,"phoneExt":81,"email":122},{"facility":143,"status":81,"city":130,"state":144,"zip":132,"country":130,"countryCode":133,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"The Duchess of Kent Children's Hospital at Sandy Bay","Sandy Bay",{"type":135,"coordinates":146},[137,138],{"lat":138,"lon":137},[149],{"name":119,"role":120,"phone":121,"phoneExt":81,"email":122},{"type":151,"investigatorFullName":152,"investigatorTitle":153,"investigatorAffiliation":5,"oldNameTitle":81,"oldOrganization":81},"PRINCIPAL_INVESTIGATOR","Prof Lawrence Lau","Assistant Professor","100653195","e-health-lifestyle-intervention-for-arthritis-a-pilot-rct-on-feasibility-100653195",false,"NCT07786038","E-Health Lifestyle Intervention for Arthritis: A Pilot RCT on Feasibility","Community Healthy Asian Lifestyle for Ameliorating Arthritis With Navigational E-health: A Pilot Randomized Controlled Trial on Feasibility and Acceptability","CHALAANE","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  1. South Asian\n  2. Men and women aged 40 to 75 years, with obesity (body mass index≥25 kg\u002Fm2, Hong Kong Centre for Health Protection obesity definition)\n  3. Knee osteoarthritis (European League Against Rheumatism (EULAR) clinical criteria): age≥40 with movement-related joint pain, morning knee stiffness\\\u003C30 min, and functional limitations, and crepitus\u002Freduced range\u002Fbony enlargement)\n  4. Pain less than 2 years\n\nExclusion Criteria:\n\n1. Unwillingness\u002Finability to change eating\u002Fphysical activity habits\n2. Severe knee OA daily resting pain (NPRS\\>8\u002F10) or (Kellgren-Lawrence grade=4) that could not tolerate further conservative management\n3. inflammatory arthritis like rheumatoid arthritis, etc.\n4. Previous knee surgery\n5. immediate requirement for joint replacement, e.g. bone loss\n6. Planning to leave HK \\>2 months during the study period\n7. cognitive impairment, vision and hearing impairment precluding use of Smartband+App\n8. losing\u002Fgaining \\>5% weight in 6months or on dieting\n9. high levels of psychological distress (Kessler 10 questionnaire-K10 score \\>29）","ALL","40 Years","75 Years",{"count":166,"type":167},50,"ESTIMATED","INTERVENTIONAL",[170],"NA","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.\n\nThis 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.",[173,174],"Knee Osteoarthristis","Obesity & Overweight",[176,177,178,179,180,181],"Knee Osteoarthritis","Obesity","Digital Health","mHealth","Artificial Intelligence","Lifestyle Intervention","NOT_YET_RECRUITING","2026-08-21",{"date":185,"type":186},"2026-08-25","ACTUAL",{"date":188,"type":167},"2026-09-01",{"date":190,"type":167},"2029-05-31",{"name":5,"class":6},2]