NTU JO-SMART Program for Obesity and Knee Osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional program targets adults with obesity and knee osteoarthritis to test whether AI-assisted community exercise plus continuous glucose monitoring can improve glycemic control. The study looks at effects on body weight, pain, function, bone density, cognition, and patient-reported outcomes, as well as risks of knee replacement and longer-term complications. Stratified analyses will consider whether participants have type 2 diabetes or chronic kidney disease at baseline. The approach leverages a mixed health-tech and exercise strategy within Taiwan, enrolling from NTU Hospital sites. Results could inform integrated lifestyle and technology-assisted care for comorbid obesity and KOA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18 to 75 years.
* Obesity status: body mass index (BMI) ≥ 27 kg/m², consistent with the obesity definition defined by the Health Promotion Administration, Ministry of Health and Welfare, Taiwan.
* Diagnosis of KOA in at least one knee according to the American College of Rheumatology (ACR) criteria, with a Kellgren-Lawrence (KL) grade of 1, 2, or 3.
* Symptomatic disease: defined as a WOMAC pain subscale score (range 0-20) greater than 4 at screening.
* Sedentary lifestyle: defined as less than 30 minutes of physical activity per week for the past 6 months.
* Informed consent: willing and able to provide written informed consent and comply with all longitudinal study procedures.
* Comorbid status: participants may be included regardless of a baseline diagnosis of T2D or CKD. Stratified randomization and subgroup analyses will be conducted based on these baseline conditions.

Exclusion Criteria:

* KL grade 4 KOA in either knee.
* Diagnosis of inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.
* Knee arthroscopy within the past 3 months or previous surgical history of TKA.
* Recent receipt of intra-articular injections (e.g., corticosteroids, hyaluronic acid) within the past 3 months.
* Documented history of osteoporotic fracture in hospital or cloud-based medical records.
* Type 1 diabetes.
* Presence of conditions precluding safe participation in an exercise program, such as unstable cardiovascular disease or severe neurological disorders.
* Participation in another interventional clinical trial within the past 3 months.
* Engagement in dietary regimens likely to cause significant weight change (e.g., intermittent fasting, such as the 16:8 time-restricted eating) within 1 month prior to trial initiation.
* Use of any FDA-approved weight-loss medications (e.g., semaglutide, tirzepatide) within 3 months prior to trial initiation.
* History of any form of surgical treatment for weight loss.
* Current use of lithium or antipsychotics at a dose equivalent to olanzapine \>20 mg/day.
* Pregnant or breastfeeding women, or women of childbearing potential without adequate contraception.
* Current malignancy (within the validity period of a catastrophic illness certificate), or any other clinical condition deemed unsuitable for participation by the investigator (investigator discretion).
* Inability to use smart devices or telecommunication tools due to severe visual/hearing impairment or lack of internet access.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan, Taiwan Recruiting
• National Taiwan University Hospital Yunlin Branch
  Yunlin, Taiwan, Taiwan Recruiting

Study contacts

• Study coordinator: Chien-Hsieh Chiang, MD, MPH, PhD
• Email: jiansie@gmail.com
• Phone: +886-2-23123456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.