Worksite Intervention Trial With Multi-Component Lifestyle Intervention and Digital Health Platform for Reduction of Body Weight and Cardio-metabolic Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Number of subjects with reduced Body Mass Index
研究概览
简要总结
Impact of lifestyle intervention in at-risk Asian Indians at worksite remains largely unexplored. The aim of this study was to assess impact of the multi-component interventions on body weight, body fat patterning and cardio-metabolic risk factors in overweight individuals working in corporate worksites in New Delhi, north India.
详细描述
A randomized open label clinical trial is planned in 4 worksites. The total study duration is 18 months. Four workplace sites will be divided into two active intervention and two control sites. Intensive awareness generation activities for overweight and obese employees and a general awareness health, nutrition and physical education programme for the rest of the employees. The study subjects will be part of awareness sessions which will be conducted in the 6 month intervention period. Besides group sessions individual diet charts will also be worked out by a trained nutritionist. Physical activity advice will be provided to them keeping their specific requirements in mind. Pedometers will be provided to them and they will be encouraged to walk for 15 minutes in pre-lunch period. Leg movements at the desk will also be encouraged.
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
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years
- •Individuals who are willing to participate in the study
排除标准
- •Previously diagnosed diabetics and patients with coronary artery disease.
- •Have received any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, (e.g. metformin, thiazolidinediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors
- •Pregnant and lactating women
- •Severe end organ damage or chronic diseases:renal/hepatic failure, any malignancy, major systemic illness etc.
- •Known case of HIV infection
- •Unwillingness to participate in the study
研究组 & 干预措施
Jindal Steel Pvt Ltd
Lifestyle intervention given
干预措施: Lifestyle intervention (Behavioral)
Maruti Udyog Ltd
Lifestyle intervention given
干预措施: Lifestyle intervention (Behavioral)
Tata Capital
Control arm so no intervention given
Powergrid Corporation
Control arm so no intervention given
结局指标
主要结局
Number of subjects with reduced Body Mass Index
时间窗: 6 months
Body Mass Index measured in kg/m\^2
次要结局
- Number of subjects with reduced Fasting Blood Glucose(6 months)
研究者
Dr Anoop Misra
Professor
Diabetes Foundation, India