AzTrials
AzTrials

Mental Health Wellness 1Uni4MoveNCT05963893

Promoting a Healthy Life Through Gender Equity

An observational study of Mental Health Wellness 1 and Physical Inactivity, run by Fundació Universitària del Bages at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Mental health, understood as the individual or group well-being at an emotional, psychological, and/or social level, affects up to 35% of university students, of whom only 16.4% seek or receive help from healthcare professionals. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Uni4Move to sit less and move more
How many people
350 participants
Where
1 siteSpain
Study dates
4 Sep 2023to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The population will consist of healthy individuals from the university community who have no contraindications for engaging in physical activity and have no difficulties in understanding Spanish or Catalan.

Who may be able to join

  • Individuals involved in the university community, including students and staff members.
  • No contraindication for participating in physical activity.

Who cannot join

  • Lack of a B2 proficiency level in either Catalan or Spanish language (as determined by an official exam).
  • Failure to provide informed consent to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guillem Jabardo Camprubí, PhD contact

691145828

gjabardo@umanresa.cat

Pau Farrés Godayol, PhD contact

pau.farres@uvic.cat

Spain1 site
  • University of Vic-Central University of Catalunya

    Manresa, Barcelona, 08242

    Guillem Jabardo Camprubí, PhD, 691145828, gjabardo@umanresa.cat

    Pau Farrés Godayol, PhD, pau.farres@uvic.cat

Other trials in Spain

About this study

Official title: Cooperative Planning Process With the University Community to Sit Less, Move More and Improve Mental Health Though a Gendered Enviromental Approach: the Uni4Move Project

Mental health, understood as the individual or group well-being at an emotional, psychological, and/or social level, affects up to 35% of university students, of whom only 16.4% seek or receive help from healthcare professionals. Despite this prevalence and its impact on academic performance and the challenges faced by universities in terms of limited resources to address this situation, most research tends to focus on primary and/or secondary education stages. Consequently, there is limited research on the reasons why university students experience mental health problems and why they do not seek help.

Physical activity and reducing sedentary behaviour could be protective factors for mental health in both children and adolescents. In this regard, according to data from the DESK-Uni at UVic-UCC, university students report engaging in low levels of physical activity, with female students reporting lower levels than male students. Additionally, adolescent girls report more mental health problems than boys. Therefore, there is a need for research and projects that consider the gender bias in health that exists in our society, including universities. This bias could explain why girls engage in less physical activity or claim to do so and why they experience more mental health problems. Thus, the purpose of the project is to improve or reduce gender inequalities within the university community and their impact on health behaviour (physical activity/sedentary behaviour) and mental health of both students and staff members.

Overall, the project aims to decrease the risks of experiencing mental health problems in the university environment by enhancing identification and promoting health-related behaviours that act as protective factors (e.g., physical activity). This will be done by considering the intersectionality of inequality axes present in our society and reproduced within the university setting. To do it, the Sustainable Development Goals (SDG; 3-4-5) will be taken in consideration.

Read the detailed description

The university environment is not separate from society, which has experienced an increase in the prevalence of mental health problems following the COVID-19 pandemic. Similarly, the university environment is not immune to the gender biases of our society: in fact, the university itself could help perpetuate and reproduce these biases if not addressed. Therefore, it is necessary to investigate which social factors, such as gender construction, can influence aspects of health (mental health problems) and behaviour (engagement in physical activity or sedentary behaviour) within the university community.

Generally, the data provided by the university community are self-reported, often estimating levels of physical activity. Consequently, these low levels of physical activity may be even higher. Therefore, it is necessary to explore physical activity levels and sedentary behaviour using accelerometers and qualitatively examine, from a gender perspective, the reasons, barriers, and facilitators that influence engagement in physical activity and the improvement of sedentary behaviour among the university community.

On the other hand, while it is true that the UManresa university offers free psychological assistance to students (up to three visits per year), the understanding of mental health by the university community can affect the utilization of this service. For example, in a society that demands strength from "men," they may be more resistant to acknowledging their mental health problems, considering it a sign of weakness, and seeking help. Therefore, understanding how the university community perceives and interprets mental health is important: how it socially constructs the meaning of mental health problems and the role that gender plays in this construction.

In the face of this situation, the following questions arise: Is there a correlation between levels of physical activity, sedentary behaviour, and the mental health status of the university community? What social and gender factors in the university environment can lead to lower levels of physical activity and more mental health problems? What actions can the university community take to improve the current situation regarding health behaviours and mental health of the university community? Additionally, considering that levels of physical activity are influenced by gender inequity and that mental health problems are partly influenced by physical activity and sedentary behaviour, it is necessary to study the relationship between mental health, health behaviours, and gender perspective.

In fact, the report "Gender perspective in research at the University" (2017), coordinated by Tània Verge Mestre (Universitat Pompeu Fabra) and Teresa Cabruja Ubach (Universitat de Girona), found that the effective incorporation of a gender perspective in university teaching remained a pending challenge, despite the existing European regulatory framework. Therefore, social inequalities may continue to persist and reproduce within the university setting. In this sense, this project aims to incorporate a gender perspective to improve the quality of teaching and the social relevance of knowledge, technologies, and innovations (re)produced. Firstly, this perspective aims to improve mental health through levels of physical activity and sedentary behaviour in the university community, both of which are associated with gender biases. On the other hand, it aims to provide students with new tools to identify gender stereotypes, norms and roles to contribute to their critical thinking and acquire competencies that will enable them to avoid gender blindness in their future professional practice. Likewise, the gender perspective allows faculty and all university staff to pay attention to gender dynamics within the learning environment and take measures to ensure that the diversity of students is addressed, thereby impacting the mental health and potential health behaviours of the entire community.

Furthermore, it is necessary to explore both physical activity and sedentary behaviour using accelerometers and how these levels are linked to mental health problems and social determinants that influence the adoption or non-adoption of a healthy lifestyle and the social construction of gender and mental illness. Secondly, it is important to collaboratively develop an action plan among all stakeholders at the university level to implement the research project's findings. Finally, the action plan should be implemented from a gender perspective to reduce sedentary behaviour, improve levels of physical activity, and consequently reduce mental health problems. The results should be evaluated annually throughout the entire trajectory of the students.

The overall objective of the project is to co-create and implement an action plan at the university level from a gender perspective to improve levels of physical activity, reduce sedentary behaviour, and consequently decrease the risk of mental health problems among members of the university community.

The specific objectives include:

  • Explore the acceptability and feasibility of implementing an action plan at the university level among different stakeholders from a gender perspective.
  • Determine the levels of physical activity and sedentary behaviour among the university community and their correlation with mental health problems.
  • Explore the experiences and factors (i.e gender inequity) that may influence the engagement in physical activity and sedentary behaviour, as well as the perception of mental health, among the university community.
  • Create a gender-inclusive guide for university teaching that addresses the needs for improving levels of physical activity, reducing sedentary behaviour, and addressing mental health problems within the university community.

Each of the specific objectives will help confirm or refute the hypothesis posed. Broadly speaking, they can be categorized into two distinct types: those focusing on quantitative and biological outcomes (correlation between physical activity, sedentary behaviour, and mental health problems) and those interpreting, applying, or seeking to transfer the results through changes and actions in the daily life of the university community.

The study follows a mixed-methods approach using a Cooperative Planning Process (CPP) model. The CPP is a participatory approach that helps create dynamic social spaces to improve change processes in healthcare and health promotion in a fair and equitable manner. Additionally, participatory interventions aim to increase the fit (adaptation) of programs within the real-life contexts of the individuals involved (university community). In this sense, the CPP has been frequently used in promoting physical activity over the past decades. The CPP is a participatory intervention strategy that brings together stakeholders involved in the change process through egalitarian decision-making to plan, develop, and implement programs that align with the demands and needs of the target population. Therefore, the CPP addresses essential principles for interventions such as the multi-dimensionality of interventions (socioecological perspective), context-specific interventions (action plan), and the reciprocal adjustment between science and clinical practice.

To carry out the CPP, the project will be divided into different phases: i) Identification of the target population members and the needs of the stakeholders. ii) Development of an action plan to address the identified needs, including co-creation of the action plan for promoting physical activity, reducing sedentary behaviour, and raising awareness of mental health within the university community. iii) Establishing the feasibility and acceptability of the co-created action plan and adapting it based on the emerging needs through an initial application within the university community. iv) Implementation of the action plan through close collaboration with the target population and stakeholders. v) Evaluation of the success of the action plan and making necessary adaptations to ensure long-term sustainability.

By following this approach, the study aims to actively involve the university community and stakeholders in the planning, development, and implementation of interventions, ultimately promoting sustainable changes in physical activity, sedentary behaviour, and mental health throughout a gender perspective.

Being tested
Uni4Move to sit less and move more
Keywords
Mental health, Physical activity, Sedentary behavior, Gender equity
Medical subject headings
Sedentary Behavior, Sexism, Psychological Well-Being, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Uni4Move to sit less and move moreBehavioural

    Co-create and implement an action plan to move more and sit less in the university context

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS at 2 years

    The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. At individual level 'minimum detectable change' has been calculated using different recommended methods giving results of 3 and 8 points. A change of 3 points means that scores on three items have improved or worsened by 1 point, or scores on one item have improved or worsened by 3 points. This suggests that the lower threshold of 3 points can be taken to represent 'meaningful change' between measurement points in individuals.

    Measured: Change from baseline at 2 years

Secondary outcomes (4)
  1. Physical Activity Levels

    Levels of light, medium and vigorous physical activity weekly in minutes

    Measured: Seven days a year during four years

  2. Sedentary behavior time

    Number of total time in minutes of sedentary behavior

    Measured: Seven days a year during four years

  3. Sedentary behavior breaks

    Number of breaks (sit-to-stand transitions)

    Measured: Seven days a year during four years

  4. Sedentary behavior bouts

    Duration of bouts in minutes (>30, 30-60, <60).

    Measured: Seven days a year during four years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start4 Sep 2023 (estimated)
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05963893
Sponsor's protocol ID
2023_14_PRI
Acronym
Uni4Move
Status last verified
Jul 2023
First submitted
5 Jul 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to share the results of the study throughout posters, oral communications, webinars and publications in cientific journals

Publications

  • Bruffaerts R, Mortier P, Kiekens G, Auerbach RP, Cuijpers P, Demyttenaere K, Green JG, Nock MK, Kessler RC. Mental health problems in college freshmen: Prevalence and academic functioning. J Affect Disord. 2018 Jan 1;225:97-103. doi: 10.1016/j.jad.2017.07.044. Epub 2017 Jul 25.

    PubMed 28802728
  • Smith PJ, Merwin RM. The Role of Exercise in Management of Mental Health Disorders: An Integrative Review. Annu Rev Med. 2021 Jan 27;72:45-62. doi: 10.1146/annurev-med-060619-022943. Epub 2020 Nov 30.

    PubMed 33256493
  • Schuch FB, Vancampfort D. Physical activity, exercise, and mental disorders: it is time to move on. Trends Psychiatry Psychother. 2021 Jul-Sep;43(3):177-184. doi: 10.47626/2237-6089-2021-0237. Epub 2021 Apr 21.

    PubMed 33890431

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health Wellness 1 and Physical Inactivity, run by Fundació Universitària del Bages at 1 site in Spain.

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 2 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: opening soon, as of the sponsor's last update on 27 Jul 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 Spain. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guillem Jabardo Camprubí, PhD (691145828, gjabardo@umanresa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS at 2 years (time frame: Change from baseline at 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05963893, which also lists 3 linked publications.

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 27 Jul 2023.

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