Development and Implementation of workplace-based lifestyle program for reducing the risk of Diabetes in employees
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1.Program adoption -Proportion of employees adopting the intervention package (assumed as 60%)
研究概览
简要总结
We plan to develop an implementation model delivering lifestyle intervention (Diet and physical activity) for 80% coverage of employees in selected KSEB offices of Kollam and Vydyuti Bhavan and to measure the success of implementation of this intervention program by evaluating program adoption, fidelity to the program ,acceptability and effectiveness of the programand to determine the effectiveness of the program among participants by evaluating the change in proportion of individuals at high risk of developing diabetes reaching two or more diabetes risk reduction goals namely reduction in waist circumference, weight , Blood pressure and HbA1C.Our sample size is 400 with outcomes being evaluated at 3 months and 6 months.The intervention will be developed in the first phase of the study through qualitative methods.The intervention components will be risk communication, goal based intervention for weight loss, physical activity and food plate delivered through peer influencers in 16 sessions of 30 minutes each
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
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Employees of Kerala State Electricity Board with indian diabetic risk score of 30 or above.
排除标准
- •1.Body Mass Index Less than 23 and or 2.waist circumference less than 90cm for men and <80 cm for women.
- •3.Those with self reported Renal,Cardiac diseases 4.Those with definite plans of migration in next one year Pregnancy.
结局指标
主要结局
1.Program adoption -Proportion of employees adopting the intervention package (assumed as 60%)
时间窗: 3 months
2.Reach of the Programme-Proportion of employees exposed to the intervention programme
时间窗: 3 months
次要结局
- 1.Program adoption by participants at 6 months 2.Reach of the programme among the participants at 6 months(3Program effectiveness by evaluating the change in proportion of individuals reaching two or more diabetic risk goals namely reduction in waist circumference(more than or to 5cm), weight reduction more than7% baseline, systolic blood pressure decrease more than or equal to 5mmHg & HbA1C decrease more than or equal to 0.5%, after 3 & 6 months of intervention)
研究者
Rekha Rachel Philip
Government Medical College Kollam