The NTU JO-SMART Study

Official title

Effects of the NTU-JO Smart Program for People With Knee Osteoarthritis and Obesity: a Multicenter Pragmatic Randomized Controlled Trial

Overview

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.

Interventions

• Behavioral NTU-JO Smart Program
  1. CGM phase (weeks 1-2) During the initial 14 days of the intervention period, participants will be equipped with a CGM device. The primary goal of this short-term monitoring is to provide real-time physiological biofeedback. By visualizing the immediate fluctuations in glucose levels, participants will directly observe the impact of specific dietary choices and physical activities on their metabolic state. This "teachable moment" is designed to enhance metabolic literacy and catalyze intrinsic

Primary outcome measures

• Number of participants with worsening glycemic control over 6 months [Time frame: From enrollment to the end of intervention at 6 months]

Secondary outcome measures (7)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index scores over 12 months [Time frame: From enrollment to the end of intervention at 6 and 12 months]
• Total knee arthroplasty requirement after intervention over 12 months [Time frame: From enrollment to the end of intervention over 12 months]
• Change in pain intensity scores over 12 months [Time frame: From enrollment to the end of intervention at 6 and 12 months]
• Changes in body weight over 12 months [Time frame: From enrollment to the end of intervention at 6 and 12 months]
• Change in Patient-Reported Outcomes Measurement Information System Physical Function scores over 12 months [Time frame: From enrollment to the end of intervention at 6 and 12 months]
• Change in BMD over 24 months [Time frame: From enrollment to the end of intervention at 12 and 24 months]
• Change in Montreal Cognitive Assessment scores over 12 months [Time frame: From enrollment to the end of intervention at 6 and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Taiwan · 2 centers

• National Taiwan University Hospital — Taipei
• National Taiwan University Hospital Yunlin Branch — Yunlin

Identifiers

NCT: NCT07317310 · 202509166RINB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗