Effects of the NTU-JO Smart Program for People With Knee Osteoarthritis and Obesity: a Multicenter Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Number of participants with worsening glycemic control over 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: NTU-JO Smart Program (Behavioral)
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.
结局指标
主要结局
Number of participants with worsening glycemic control over 6 months
时间窗: 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)
次要结局
- Change in Western Ontario and McMaster Universities Osteoarthritis Index scores over 12 months(From enrollment to the end of intervention at 6 and 12 months)
- Total knee arthroplasty requirement after intervention over 12 months(From enrollment to the end of intervention over 12 months)
- Change in pain intensity scores over 12 months(From enrollment to the end of intervention at 6 and 12 months)
- Changes in body weight over 12 months(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(From enrollment to the end of intervention at 6 and 12 months)
- Change in BMD over 24 months(From enrollment to the end of intervention at 12 and 24 months)
- Change in Montreal Cognitive Assessment scores over 12 months(From enrollment to the end of intervention at 6 and 12 months)