Healthy LifestyleIFPDaysNCT05492162
An Intervention to Promote Health Students' Well-being
A study testing well-being promotion intervention in people with Healthy Lifestyle and Students Wellbeing, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
The lack of well-being observed among health students underscores the urgent need of implementing interventions designed to meet their specific need and improving their quality of life. This study aims to evaluate a well-being promotion intervention among paramedic students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Students Wellbeing
- What is being tested?
- well-being promotion intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18 years
- paramedic students enrolled at IFP Mary Thieullent in september 2022
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Intervention to Promote Health Students' Well-being : a Protocol of a Quasi-experimental Interventional Study in Le Havre
The lack of well-being observed among health students underscores the urgent need of implementing interventions designed to meet their specific need and improving their quality of life.
This study aims to evaluate a well-being promotion intervention among paramedic students.
This is a before/after study using a quasi-experimental design. This study aims to compare well-being, resilience, and self-esteem before and after the intervention.
Students' satisfaction will be assessed through a questionnaire.
Read the detailed description
Health students' well-being is a big issue today. We need to increase the number of interventions designed to improve quality of life and well-being among this population of students.
The investigators aim to evaluate a well-being promotion intervention among paramedic students through a before/after study using a quasi-experimental design by comparing the scores of validated scales of well-being, resilience, and self-esteem of participating students before and after the intervention.
A satisfaction questionnaire will allow to assess the content and the organization of this intervention.
The first edition will be implemented in September 2022 in Le Havre. The questionnaires will be distributed before and eight months after the intervention.
The investigators will describe the study population, then they will compare the average scores.
The results of satisfaction questionnaire will allow to improve the intervention to best meet the needs of students.
The main benefit expected from this study is the improvement of paramedic students' well-being by adopting a healthy lifestyle.
- Conditions
- Healthy Lifestyle, Students Wellbeing
- Being tested
- well-being promotion intervention
- Keywords
- health promotion, wellness program, health occupations students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
well-being promotion interventionOther
The intervention will be organized on both conferences and workshops.
Four themes will be covered :
- Well-being (Workshops)
- Smoking prevention (Conference)
- Balanced diet (Workshop)
- Optimal organization for daily healthy living (Conference)
| Study group | Role | What they receive |
|---|---|---|
| paramedic students | Other | para-experimental arm Receives: Other: well-being promotion intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being
Change of average scores of Warwick-Edinburgh Mental Wellbeing Scale - 14 items Scores from 14 to 70: the higher score indicates a better wellbeing
Measured: Month 1 and Month 8
Secondary outcomes (3)
Resilience
Change of average scores of Connor-Davidson Resilience scale - 10 items Scores from 0 to 40: the higher score indicates a strong resilience
Measured: Month 1 and Month 8
Self-esteem
Change of average scores of Rosenberg scale - 10 items Scores from 10 to 40 : the higher score indicates a better self-esteem
Measured: Month 1 and Month 8
Students' Satisfaction
Satisfaction data will be analyzed to identify the strengths and the areas for improving the intervention (qualitative and qualitative analyses)
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Sep 2022
- Primary completion3 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before/after study using a quasi-experimental design
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492162
- Sponsor's protocol ID
- IFPDays
- Acronym
- IFPDays
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Promote Health Students' Well-being : a Protocol of a Quasi-experimental Interventional Study in Le Havre
- ClinicalTrials.gov ID
- NCT05492162
- Acronym / sponsor ID
- IFPDays / IFPDays
- Conditions
- Healthy Lifestyle, Students Wellbeing
- Keywords
- health promotion, wellness program, health occupations students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The lack of well-being observed among health students underscores the urgent need of implementing interventions designed to meet their specific need and improving their quality of life.
This study aims to evaluate a well-being promotion intervention among paramedic students.
This is a before/after study using a quasi-experimental design. This study aims to compare well-being, resilience, and self-esteem before and after the intervention.
Students' satisfaction will be assessed through a questionnaire.
Detailed description
Health students' well-being is a big issue today. We need to increase the number of interventions designed to improve quality of life and well-being among this population of students.
The investigators aim to evaluate a well-being promotion intervention among paramedic students through a before/after study using a quasi-experimental design by comparing the scores of validated scales of well-being, resilience, and self-esteem of participating students before and after the intervention.
A satisfaction questionnaire will allow to assess the content and the organization of this intervention.
The first edition will be implemented in September 2022 in Le Havre. The questionnaires will be distributed before and eight months after the intervention.
The investigators will describe the study population, then they will compare the average scores.
The results of satisfaction questionnaire will allow to improve the intervention to best meet the needs of students.
The main benefit expected from this study is the improvement of paramedic students' well-being by adopting a healthy lifestyle.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before/after study using a quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| paramedic students | Other | Other: well-being promotion interventionpara-experimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age >18 years
- paramedic students enrolled at IFP Mary Thieullent in september 2022
Key exclusion criteria (1 listed)
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| well-being promotion interventionThe intervention will be organized on both conferences and workshops. Four themes will be covered : * Well-being (Workshops) * Smoking prevention (Conference) * Balanced diet (Workshop) * Optimal organization for daily healthy living (Conference) | Other | paramedic students |
Primary outcome
Well-being
Time frame: Month 1 and Month 8
Change of average scores of Warwick-Edinburgh Mental Wellbeing Scale - 14 items Scores from 14 to 70: the higher score indicates a better wellbeing
3 secondary outcomes
Resilience
Time frame: Month 1 and Month 8
Self-esteem
Time frame: Month 1 and Month 8
Students' Satisfaction
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing well-being promotion intervention in people with Healthy Lifestyle and Students Wellbeing, run by Groupe Hospitalier du Havre at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being (time frame: Month 1 and Month 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.