NCT07317310Recruiting
The NTU JO-SMART Study
Effects of the NTU-JO Smart Program for People With Knee Osteoarthritis and Obesity: a Multicenter Pragmatic Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
This study recruits patients with coexisting obesity and knee osteoarthritis (KOA) to implement the NTU-JO Smart Program, an innovative intervention integrating AI-assisted community-based exercise with continuous glucose monitoring (CGM). The primary objective is to investigate whether this intervention can improve glycemic control in this comorbid population. Other outcome measures include the risk of total knee arthroplasty (TKA), body weight changes, pain intensity scores, bone mineral density (BMD), cognitive function, as well as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores, which reflect the patients' overall functional status. The project also sought to explore the long-term association of the NTU-JO Smart Program with the development of type 2 diabetes (T2D) and major renal events, thereby facilitating patient-centered early treatment.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 7 Dec 2025
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Chronic kidney disease, Obesity
- NCT number
- NCT07317310
What you commit to
- Study type: Interventional
- Planned participants: 312
- From 1 Aug 2026 to the primary completion date, 31 Dec 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
- History of any form of surgical treatment for weight loss.
- 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.
Other
- KL grade 4 KOA in either knee.
- Diagnosis of inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.
- Participation in another interventional clinical trial within the past 3 months.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital Yunlin Branch Coordinator of this site? Confirm its status | Yunlin | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.