Clinical trial NCT06137898: The Benefits of Dietary and Micro-nutritional Management for Well-being at Work
Official title: The Benefits of Dietary and Micro-nutritional Management for Well-being at Work
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Well-Being, Psychological
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult wishing to initiate dietetic and micro-nutritional management of their state of health

Brief summary: 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.

Detailed description: 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.

These visits can take place face-to-face with an investigating physician, or by teleconsultation.

A statistical analysis plan will precisely indicate the populations studied, the analysis procedures, the treatment of missing data envisaged, the statistical tests for each variable and for the analysis of the primary and secondary judgment criteria to be used.

The threshold of statistical significance will be defined at the risk alpha = 0.05.

Trial data will be collected :

* by investigators for biological and clinical data on the e-CRF
* by participants on their smartphones using the data acquisition system for self-questionnaires.

Description of the population:

Descriptions of subjects included in the study will be made by mean and standard deviation for quantitative variables and by frequency and numbers for qualitative variables.

Analysis of endpoints:

Changes in WHO5, MSP9 scores and biological variables will be analyzed using a repeated-measures ANOVA. The same analyses will be carried out on secondary criteria. Correlations between changes in WHO5 and MSP-9 scores and changes in biological and clinical and clinical data.

Sample size:

The required sample size is based on the evolution of the WHO-5 global score between the initial visit and the 6-month follow-up visit using a two-tailed paired t-test with an estimated mean evolution of 5, an estimated standard deviation of 19 (12) and a confidence level of 90. 154 subjects are required, which is rounded up to 200 to account for unexploitable records (≈10%) or premature study withdrawals (≈10%).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant or breast-feeding women
* Participating in another study or in the exclusion period
* Person under court protection

Primary outcomes:
measure: Evolution of WHO-5
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Evolution of subjective well-being
timeFrame: Each month up to 12 months
measure: Evolution of psychological stress
timeFrame: Each month up to 12 months
measure: Evolution of biological parameters
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Prevention and evolution of symptomatologies mainly linked to nutritional nutritional/micro-nutritional status
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Describe compliance with hygienodietary and micro-nutritional follow-up.
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Describe satisfaction with hygienodietary and micro-nutritional follow-up.
timeFrame: Month 3, Month 6, Month 12
Other outcomes:
Locations:
city: Dijon
country: France
facility: CEN
Study officials:
affiliation: CEN
name: Carole PERRIN
role: PRINCIPAL_INVESTIGATOR
References: