The NTU JO-SMART Study

National Taiwan University

Status: Begins enrollment in 5 months

Conditions: Chronic Kidney Disease; Diabetes (DM); Obesity & Overweight; Knee Osteoarthristis

Treatments: Behavioral: NTU-JO Smart Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07317310

202509166RINB

Details and patient eligibility

About

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.

Enrollment: 312 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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312 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group will receive a multicomponent integrated care package comprising a short-term biofeedback phase (CGM) and a long-term behavioral and exercise phase (AI-assisted exercise).

Treatment:

Behavioral: NTU-JO Smart Program

Usual care group

No Intervention group

Description:

Participants randomized to the control group will receive usual care, defined as standard clinical management for KOA and obesity provided at the outpatient departments of NTUH. This includes routine physician consultations, standard advice on weight management and physical activity, and pharmacological management as clinically indicated. No specific exercise prescription, smart equipment access, or CGM feedback will be provided.