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NCT07786038
E-Health Lifestyle Intervention for Arthritis: A Pilot RCT on Feasibility
Conditions: Knee Osteoarthristis, Obesity & Overweight
Sex: All
Ages: 40 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: The University of Hong Kong
Location: Queen Mary Hospital Hong Kong Pofuklam
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.
Eligibility Criteria
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\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)
Source: ClinicalTrials.gov (NCT07786038). StuddyBuddy aggregates publicly available trial information.