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

NCT07786038 | Not Yet Recruiting

• 1 other identifier: UW 25-563
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Knee Osteoarthristis; Obesity & Overweight

Keywords

Knee Osteoarthritis; Obesity; Digital Health; mHealth; Artificial Intelligence; Lifestyle Intervention

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  12 months (throughout recruitment period)

Secondary Outcomes (19)

• Performance-Based Functional Limitation Assessed by Gait Speed

  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

  Baseline, 1 month, 4 months, 7 months, and 10 months

• Pain Intensity Assessed by the Numerical Pain Rating Scale

  Baseline, 1 month, 4 months, 7 months, and 10 months

• Pain Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale

  Baseline, 1 month, 4 months, 7 months, and 10 months

• Stiffness Assessment Using the Western Ontario and McMaster Universities Osteoarthritis Index Stiffness Subscale

  Baseline, 1 month, 4 months, 7 months, and 10 months

Study Arms (2)

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.

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.

Device: Inactivated Smartband for Activity Monitoring

Interventions

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).

Inactivated Smartband Only

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.

CHALAANE Program

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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）

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, Pofuklam, 999077, Hong Kong

Location

The Duchess of Kent Children's Hospital at Sandy Bay

Hong Kong, Sandy Bay, 999077, Hong Kong

Location

MeSH Terms

Conditions

Obesity; Overweight; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F

CONTACT

92646862; laucml@hku.hk

Kejing Eunice Ms. Xiao, Master

CONTACT

54845721; eunice7@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)