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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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). |
|
| Usual care group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTU-JO Smart Program | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to the end of intervention at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of intervention at 6 and 12 months |
| Total knee arthroplasty requirement after intervention over 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chien-Hsieh Chiang, MD, MPH, PhD | Contact | +886-2-23123456 | jiansie@gmail.com | |
| Shengyong Tang, MD | Contact | +886-928436686 | tangsam0627@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chien-Hsieh Chiang, MD, MPH, PhD | National Taiwan University Hospital & College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan | 100 | Taiwan |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D050177 | Overweight |
| D051436 | Renal Insufficiency, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Participants will be randomly assigned to the intervention or control group using stratified block randomization. To ensure balance between groups regarding key prognostic factors, the randomization process will be stratified by the following variables: (1) Study center (NTUH vs. NTUH Yunlin Branch); (2) Baseline diabetes status (with T2D vs. without T2D). The allocation process will be managed through a centralized, secure web-based system. This mechanism ensures allocation concealment, preventing recruitment personnel from influencing or predicting participant assignment.
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Due to the nature of the behavioral and lifestyle intervention, it is not feasible to blind the participants or the personnel delivering the intervention (open-label design). Therefore, the primary strategy to minimize bias will be outcome assessor blinding. Research personnel responsible for conducting follow-up assessments and data collection will be distinct from those delivering the intervention and will remain blinded to the participants' group allocation throughout the study. Furthermore, the biostatisticians performing the data analysis will also be blinded to group assignment during the statistical analysis phase
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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. |
| 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. | 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 | 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. | 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. | 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). | From enrollment to the end of intervention at 6 and 12 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. |
| From enrollment to the end of intervention at 6, 12, and 24 months |
| National Taiwan University Hospital Yunlin Branch | Yunlin | Taiwan | 640 | Taiwan |
|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D001519 | Behavior |