The NTU JO-SMART Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease; Diabetes (DM); Obesity & Overweight; Knee Osteoarthristis
• Intervention / Treatment: Behavioral: NTU-JO Smart Program

• Study Type: Interventional
• Enrollment (Estimated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chien-Hsieh Chiang, MD, MPH, PhD; Phone Number: +886-2-23123456; Email: jiansie@gmail.com
• Study Contact Backup: Name: Shengyong Tang, MD; Phone Number: +886-928436686; Email: tangsam0627@gmail.com

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 100
      • National Taiwan University Hospital
      • Principal Investigator: Chien-Hsieh Chiang, MD, MPH, PhD
      • Contact: Chien-Hsieh Chaing, MD, MPH, PhD; Phone Number: +886-2-23123456; Email: jiansie@gmail.com
      • Contact: Sheng-yong Tang, MD; Email: tangsam0627@gmail.com
      • Sub-Investigator: Tsung-Ren Huang, PhD
      • Sub-Investigator: Sheng-yong Tang, MD
      • Sub-Investigator: Tse-Yuan Chen, MD
      • Sub-Investigator: Kuo-Chin Huang, MD, PhD
      • Sub-Investigator: Ming-Hsiao Hu, MD, PhD
      • Sub-Investigator: Yih-Hsien Kao, MD
      • Sub-Investigator: Hung-Kuan Yen, MD
    • Yunlin, Taiwan, Taiwan, 640
      • National Taiwan University Hospital Yunlin Branch
      • Contact: Tsung-Yi Yen, MD; Phone Number: +886-5-5323911; Email: b90401045@gmail.com
      • Contact: Tsung-Yi Yen, MD; Email: yantsungyi@gmail.com
      • Sub-Investigator: Shau-Huai Fu, MD, PhD
      • Principal Investigator: Tsung-Yi Yen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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
No Intervention: Usual care group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science and Technology Council, Taiwan
• Investigators: Study Chair: Chien-Hsieh Chiang, MD, MPH, PhD, National Taiwan University Hospital & College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): July 31, 2035

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Exercise; obesity; Chronic kidney disease; continuous glucose monitoring; Knee osteoarthristis
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus; Renal Insufficiency, Chronic; Motor Activity
• Other Study ID Numbers: 202509166RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No