E-Health Lifestyle Intervention for Arthritis: A Pilot RCT on Feasibility | NCT07786038 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 25, 2026

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07786038
Lead Sponsor: The University of Hong KongOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 50Estimated
Last Update Posted: Aug 25, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Dec 31, 2028Estimated
Completion Date: May 31, 2029Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Community Healthy Asian Lifestyle for Ameliorating Arthritis With Navigational E-health: A Pilot Randomized Controlled Trial on Feasibility and Acceptability
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

The medical conditions and diseases this study investigates.

Knee Osteoarthristis
Obesity & Overweight

Interventions

The treatments and procedures being evaluated in this study.

Digital Health Intervention
Inactivated Smartband for Activity Monitoring

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Inclusion criteria:

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

Exclusion Criteria:

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）

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

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

laucml@hku.hk92646862

Locations

Where the study is run and whether each site is currently recruiting.

Queen Mary Hospital

Hong Kong, Pofuklam 999077, Hong Kong

Collaborators

The organizations and people involved in this study.

Lead Sponsor: The University of Hong KongOTHER

Similar Studies

Other registered studies that closely resemble this one.

Detailed Description

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.