NCT05963893

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Sep 2023Jun 2027

First Submitted

Initial submission to the registry

July 5, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 5, 2023

Last Update Submit

July 25, 2023

Conditions

Keywords

Mental healthPhysical activitySedentary behaviorGender equity

Outcome Measures

Primary Outcomes (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.

    Change from baseline at 2 years

Secondary Outcomes (4)

  • Physical Activity Levels

    Seven days a year during four years

  • Sedentary behavior time

    Seven days a year during four years

  • Sedentary behavior breaks

    Seven days a year during four years

  • Sedentary behavior bouts

    Seven days a year during four years

Interventions

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vic-Central University of Catalunya

Manresa, Barcelona, 08242, Spain

Location

Related Publications (3)

  • 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.

    PMID: 28802728BACKGROUND
  • 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.

    PMID: 33256493BACKGROUND
  • 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.

    PMID: 33890431BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorSexismPsychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

BehaviorPrejudiceSocial BehaviorSocial DiscriminationPersonal Satisfaction

Study Officials

  • Guillem Jabardo Camprubí, PhD

    Faculty of Health Science at Manresa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillem Jabardo Camprubí, PhD

CONTACT

Pau Farrés Godayol, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 27, 2023

Study Start

September 4, 2023

Primary Completion

June 30, 2024

Study Completion (Estimated)

June 30, 2027

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

We plan to share the results of the study throughout posters, oral communications, webinars and publications in cientific journals

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Results will be share once a year
Access Criteria
Through out posters, communications, webinars and publications

Locations