An interventional study of NTU-JO Smart Program in Knee Osteoarthristis, Diabetes (DM) and Obesity & Overweight, sponsored by National Taiwan University Hospital. Recruiting at 2 sites in Taiwan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 312 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
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).
Behavioral: NTU-JO Smart Program
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.
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 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
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 months
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 months
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 months
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 months
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 months
Change in Patient-Reported Outcomes Measurement Information System Physical Function scores over 12 months
The raw Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score is converted to a T-score centered at 50 (average), with higher T-scores meaning better ability.
Time frame: From enrollment to the end of intervention at 6 and 12 months
Change in BMD over 24 months
Change in bone mineral density assessed by dual-energy X-ray absorptiometry.
Time frame: From enrollment to the end of intervention at 12 and 24 months
Change in Montreal Cognitive Assessment scores over 12 months
The cognitive function is assessed using the Montreal Cognitive Assessment (MoCA) scores. The MoCA scores range from 0 to 30 (better).
Time frame: From enrollment to the end of intervention at 6 and 12 months
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 months
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 months
Plan to share: No
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