The Benefits of Dietary and Micro-nutritional Management for Well-being at Work
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Larena SAS
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evolution of WHO-5
研究概览
简要总结
The aim of this observational study is to describe the benefits of this treatment, particularly in terms of changes in the well-being of participating employees in relation to their nutritional/micro-nutritional status.
详细描述
Biological check-ups and medical appointments with the investigators will be carried out as part of the hygienic-dietary and micro-nutritional management that study participants have enrolled in. No additional investigations or blood sampling are required for the study. Participants will only be asked to complete the WHO5 and MSP9 self-questionnaires once a month, for 12 months. The inclusion visit will take place at the same time as the first medical visit for dietary and nutritional management. After obtaining the participant's non-opposition, the investigator will check the inclusion and non-inclusion criteria.
If eligible, the participant will download a data collection application onto his or her smartphone, and will be provided with an identifier and access code.
As part of the program, dietary hygiene and micro-nutritional recommendations will be proposed on the basis of the results of a biological (blood test) and nutritional (interview with the doctor) assessment. If necessary, the doctor may prescribe additional blood tests on a regular basis, and will carry out nutritional assessments to adapt the program's management.
The program will be organized into 5 visits:
- a first visit V0 (micro-nutritional interview) with a biological check-up ;
- a second V1 visit (within a fortnight of the initial visit) to review all the results of the initial assessment and, if necessary, to implement hygienic-dietary and/or nutritional recommendations (in the form of cards) and/or a micro-nutritional prescription;
- quarterly follow-up visits (at 3 and 6 months) and a visit at 1 year to carry out check-ups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Wishing to initiate dietetic and micro-nutritional management of their state of health
- •Having freely declared to the investigator that he/she does not object to his/her participation in the study the study and to the collection of data strictly necessary for the study, after having received informed oral and written information from the investigator
- •Have a smartphone compatible with the secure data collection application
排除标准
- •Pregnant or breast-feeding women
- •Participating in another study or in the exclusion period
- •Person under court protection
结局指标
主要结局
Evolution of WHO-5
时间窗: Baseline, 6 months
Evolution of World Health Organization Well-Being Index score (WHO 5) between M0 inclusion (V1) and 6 months after the start of management (V3).
次要结局
- Describe compliance with hygienodietary and micro-nutritional follow-up.(Baseline, Month 3, Month 6, Month 12)
- Evolution of subjective well-being(Each month up to 12 months)
- Evolution of biological parameters(Baseline, Month 3, Month 6, Month 12)
- Evolution of psychological stress(Each month up to 12 months)
- Prevention and evolution of symptomatologies mainly linked to nutritional nutritional/micro-nutritional status(Baseline, Month 3, Month 6, Month 12)
- Describe satisfaction with hygienodietary and micro-nutritional follow-up.(Month 3, Month 6, Month 12)