The NTU JO-SMART Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-01

Study Completion Date

2035-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Knee Osteoarthristis Diabetes (DM) Obesity & Overweight Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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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).

Group Type EXPERIMENTAL

NTU-JO Smart Program

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NTU-JO Smart Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No