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NCT Number: NCT07317310

The NTU JO-SMART Study

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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Key information

Conditions

Knee Osteoarthristis Behavior Body Weight Chronic Disease Chronic Kidney Disease Diabetes (DM) Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Taipei, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NTU-JO Smart Program

Behavioral
  • 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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function subscale score ranges from 0 to 68 (severe).

  2. Total knee arthroplasty requirement after intervention over 12 months

    Time frame: From enrollment to the end of 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.

  3. Change in pain intensity scores over 12 months

    Time frame: From enrollment to the end of intervention at 6 and 12 months

    Change in pain intensity scores on a 0-10 numeric scale.

  4. Changes in body weight over 12 months

    Time frame: From enrollment to the end of intervention at 6 and 12 months

    Changes in body weight in kilograms

  5. 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

    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.

  6. Change in BMD over 24 months

    Time frame: From enrollment to the end of intervention at 12 and 24 months

    Change in bone mineral density assessed by dual-energy X-ray absorptiometry.

  7. Change in Montreal Cognitive Assessment scores over 12 months

    Time frame: From enrollment to the end of intervention at 6 and 12 months

    The cognitive function is assessed using the Montreal Cognitive Assessment (MoCA) scores. The MoCA scores range from 0 to 30 (better).

Other outcomes

  1. Number of participants with new-onset type 2 diabetes over 24 months

    Time frame: From enrollment to the end of intervention at 6, 12, and 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.

  2. Number of participants with new-onset major renal events over 24 months

    Time frame: From enrollment to the end of intervention at 6, 12, and 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chien-Hsieh Chiang, MD, MPH, PhD

CONTACT

[email protected]

+886-2-23123456

Shengyong Tang, MD

CONTACT

[email protected]

+886-928436686

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

Effects of the NTU-JO Smart Program for People With Knee Osteoarthritis and Obesity: a Multicenter Pragmatic Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2029
Study completion
2035
First posted
Jan 5, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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