Knee OsteoarthristisNCT07317310
The NTU JO-SMART Study
A study testing NTU-JO Smart Program in people with Knee Osteoarthristis and Diabetes (DM), run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthristis, Diabetes (DM), Obesity & Overweight
- What is being tested?
- NTU-JO Smart Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Aug 2026to 31 Jul 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Chien-Hsieh Chaing, MD, MPH, PhD, +886-2-23123456, jiansie@gmail.com
Sheng-yong Tang, MD, tangsam0627@gmail.com
- Recruiting
National Taiwan University Hospital Yunlin Branch
Yunlin, Taiwan, 640
Tsung-Yi Yen, MD, +886-5-5323911, b90401045@gmail.com
Tsung-Yi Yen, MD, yantsungyi@gmail.com
About this study
Official title: Effects of the NTU-JO Smart Program for People With Knee Osteoarthritis and Obesity: a Multicenter Pragmatic Randomized Controlled 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.
- Being tested
- NTU-JO Smart Program
- Keywords
- Diabetes, Chronic kidney disease, Knee osteoarthristis, obesity, Exercise, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Obesity, Overweight, Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTU-JO Smart ProgramBehavioural
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: NTU-JO Smart Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to the end of intervention at 6 months
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment to the end of intervention at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chien-Hsieh Chiang, MD, MPH, PhD, Study chair, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317310
- Sponsor's protocol ID
- 202509166RINB
- Status last verified
- Jul 2026
- First submitted
- 7 Dec 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the NTU-JO Smart Program for People With Knee Osteoarthritis and Obesity: a Multicenter Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07317310
- Acronym / sponsor ID
- 202509166RINB
- Keywords
- Diabetes, Chronic kidney disease, Knee osteoarthristis, obesity, Exercise, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Jul 2035 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: NTU-JO Smart ProgramThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTU-JO Smart Program1. 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 | Behavioural | Intervention group |
Primary outcome
Number of participants with worsening glycemic control over 6 months
Time frame: From enrollment to the end of intervention at 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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chien-Hsieh Chiang, MD, MPH, PhD study chair
National Taiwan University Hospital & College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NTU-JO Smart Program in people with Knee Osteoarthristis and Diabetes (DM), run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chien-Hsieh Chiang, MD, MPH, PhD (+886-2-23123456, jiansie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with worsening glycemic control over 6 months (time frame: From enrollment to the end of intervention at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.