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临床试验/CTRI/2026/01/100028
CTRI/2026/01/100028尚未招募不适用

Development and Validation of a Novel, Third-Generation Lifestyle (Exercise and Nutrition) Prescription for Precision Medicine in Indians with cardio metabolic diseases (DEVELOP Study).

ICMR1 个研究点 分布在 1 个国家目标入组 2,250 人开始时间: 2026年1月22日最近更新:

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

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Pranathi Racha

St. Johns Medical College

研究点 (1)

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