The NTU JO-SMART Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NTU-JO Smart Program
Behavioral1. 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 motivation for sustained behavioral modification. 2. AI-assisted community-based exercise program (months 1-6) Following the initial assessment at the NTUH Exercise Counseling \& Prescription Clinic, participants will engage in a 6-month, structured, multicomponent exercise program. This program integrates facility-based training using smart equipment with remote health coaching, designed to overcome common barriers to adherence in patients with KOA and obesity
Treatment groups
312 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Usual care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants with worsening glycemic control over 6 months
Risk of worsening glycemic control, defined as an increase in glycated hemoglobin (HbA1c) of ≥ 0.5% from baseline assessed over the 6-month intervention period (regardless of baseline diabetes diagnosis)
Time frame
From enrollment to the end of intervention at 6 monthsSecondary outcomes
1
Change in Western Ontario and McMaster Universities Osteoarthritis Index scores over 12 months
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function subscale score ranges from 0 to 68 (severe).
Time frame
From enrollment to the end of intervention at 6 and 12 months2
Total knee arthroplasty requirement after intervention over 12 months
Incidence of progression to total knee arthroplasty requirement (defined as worsening of KL grade to grade 4 in either knee) during the follow-up period.
Time frame
From enrollment to the end of intervention over 12 months3
Change in pain intensity scores over 12 months
Change in pain intensity scores on a 0-10 numeric scale.
Time frame
From enrollment to the end of intervention at 6 and 12 months4
Changes in body weight over 12 months
Changes in body weight in kilograms
Time frame
From enrollment to the end of intervention at 6 and 12 monthsOther outcomes
1
Number of participants with new-onset type 2 diabetes over 24 months
Risk of new-onset type 2 diabetes (in participants without a baseline diagnosis of diabetes), defined according to the American Diabetes Association (ADA) Standards of Care.
Time frame
From enrollment to the end of intervention at 6, 12, and 24 months2
Number of participants with new-onset major renal events over 24 months
Risk of new-onset major renal events, defined as a composite endpoint: for participants without CKD at baseline, the development of new-onset CKD; or for participants with existing CKD, worsening of renal function or death (defined as a sustained decline in estimated glomerular filtration rate (eGFR) of \> 40%, onset of ESRD, or death from renal causes). CKD definition: eGFR \< 60 ml/min/1.73 m², or eGFR \> 60 ml/min/1.73 m² accompanied by evidence of kidney damage (e.g., microalbuminuria, hematuria, or pathological findings) persisting for at least three months.
Time frame
From enrollment to the end of intervention at 6, 12, and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
National Science and Technology Council, Taiwan
Collaborator
Source ClinicalTrials.gov