Development and Validation of a Novel, Third-Generation Lifestyle (Exercise and Nutrition) Prescription for Precision Medicine in Indians with cardio metabolic diseases (DEVELOP Study).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 2,250
- 试验地点
- 1
研究概览
简要总结
Cardiometabolic diseases (CMDs) such as hypertension, dyslipidaemia, and type 2 diabetes significantly increase cardio- and cerebrovascular risk. Conventional manually written first-generation lifestyle prescriptions show sub- optimal adherence, while second-generation electronic prescriptions without artificial intelligence (AI) are limited in India. Third-generation lifestyle prescriptions integrate wearable, clinical and physiological parameters, genetic information, and evidence-based guidelines using AI/machine-learning (ML) tools to generate precise, individualised recommendations, an approach unexplored in India. This study proposes the development of a culturally relevant Third-Generation Precision Lifestyle Prescription (TGPLP) that can be customised by treating physicians. Objective 1 is to develop TGPLP using detailed prospective data from 2,000 participants across CMD stages, integrating genetic, wearable, clinical, and lifestyle datasets through AI/ML. Objective 2 is to evaluate the preliminary efficacy of TGPLP on adherence to physical activity and diet over 12 weeks through a pilot randomised controlled trial in 200 particpants. Objective 3 is to assess cost, acceptability, and scalability to inform a future multi-centre RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy volunteers and Cardio Metabolic patients (stages 0-4) (table 1) (2), aged 18-60 years, sedentary to moderately active (PAL 2) 34, willing to adapt to exercise and provide informed consent.
排除标准
- •Contraindications to structured exercise (e.g., uncontrolled hypertension, unstable angina), inability to exercise due to conditions like osteoarthritis, or non-compliance risks (e.g., distant residence, cognitive impairment).
研究者
Dr Pranathi Racha
St. Johns Medical College
