UNIversity college students’ LIFEstyle behaviours and Mental well being cohort (UNILIFE-M): research protocol of a multicentre, potential cohort research

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Background

The transition to college entails vital shifts in social, educational and monetary calls for.1 2 Adapting to those new challenges requires a reorganisation of way of life routine and behaviours.3 Previous research assist that the transition to college influences a number of way of life behaviours, displaying that college college students typically exhibit excessive ranges of bodily inactivity4 and sedentary behaviour,5 poor and unbalanced diets,3 excessive charges of alcohol and substance misuse,6 poor sleep patterns7 and elevated display time.8

Lifestyle behaviours are modifiable threat components for the event of psychological well being signs.9 High ranges of bodily inactivity, poor food plan, poor sleep high quality, substance misuse and extreme display publicity are related to an elevated threat of psychological well being signs.10–18

Mental well being signs and issues are extremely prevalent worldwide, in all populations, together with college college students. According to the World Mental Health Report Update 2024 by the WHO, roughly one in each seven individuals globally (15–18%) lives with a psychological dysfunction at any given time, representing round 1.3 billion people. Depression and nervousness are probably the most frequent situations, and the worldwide burden of psychological issues has continued to extend over the previous decade, largely affecting youthful age teams. The Lancet Psychiatry Commission (2024) estimated that psychological well being issues account for about US$ 6 trillion in financial losses yearly, on account of healthcare prices, decreased productiveness and social exclusion, a determine projected to rise to US$ 8.5 trillion by 2030. 19–21Among college college students, the prevalence of psychological well being issues has reached alarming ranges. A latest meta-analysis together with knowledge from over 90 000 college students throughout 37 international locations reported pooled prevalence charges of 27% for depressive signs, 23% for nervousness and 19% for stress-related signs, with greater figures in low- and middle-income international locations.22 A world research carried out in 2024 by the Healthy Minds Network discovered that almost 44% of scholars met standards for no less than one psychological well being situation, and solely one-third reported having acquired enough psychological assist.23 Also, the transition interval to greater schooling coincides with the height onset age for many psychiatric issues (18–35 years), reinforcing the significance of prevention methods on this inhabitants.24 However, most research to this point have solely examined the connection between particular person way of life behaviours and psychological well being signs (eg, sleep and despair).10–18

Lifestyle behaviours incessantly co-occur in clusters moderately than in isolation.11–25 Among college college students, greater ranges of bodily exercise are related to higher dietary habits and decrease smoking charges.26 27 Conversely, greater bodily exercise ranges may additionally coincide with elevated alcohol consumption,28 whereas sedentary behaviour is linked to poor sleep however not smoking.29 Given the character of those behaviour clusters, it’s believable that assessing a number of way of life behaviours concurrently might supply a extra complete and person-centred method to understanding the associations between way of life and psychological well being signs.30

Some proof means that clusters of way of life behaviours are related to psychological well being outcomes amongst college college students.31–37 In a research of Australian college students,31 4 distinct clusters had been recognized: ‘healthiest’, ‘healthy’, ‘mixed’ and ‘sedentary and distressed’. The ‘healthiest’ cluster (characterised by greater ranges of bodily exercise and fruit consumption, decrease binge consuming and the least sedentary behaviour) was related to the bottom ranges of despair, nervousness and stress in contrast with the opposite clusters. Another research of Australian college students recognized three clusters: ‘healthier’, ‘moderate’” and ‘unhealthier’ existence, with the latter two being linked to greater psychological misery dangers.38 Among Chinese college students,37 4 clusters had been discovered: (1) energetic sample (these with greater ranges of bodily exercise); (2) excessive sleep length sample; (3) excessive display time sample; and (4) low bodily exercise/low sleep length sample. The research concluded that college students with low bodily exercise and low sleep length confronted a better threat of depressive signs. Nevertheless, many of the earlier proof relies on cross-sectional research, offering no perception into the temporality of the associations.

The Seguimiento Universidad de Navarra (SUN) cohort is among the few potential research displaying that college students who adhered to 10 wholesome way of life behaviours, termed the ‘healthier lifestyle’ cluster (eg, smoking cessation, bodily exercise, nutritious diet, applicable physique mass index, average alcohol consumption, low tv publicity, avoidance of binge consuming, common naps, social interplay and work engagement), had a 32% decrease threat of growing despair in contrast with these reporting three or fewer wholesome behaviours.39 However, this proof is proscribed to despair, hindering the generalisation of findings to different psychological well being signs.

Lifestyle behaviours and psychological well being signs are influenced by contextual components, similar to cultural and social influences.40 41 Some literature means that sure way of life behaviours universally shield in opposition to psychological well being points,15 42 whereas the affiliation of others could also be context particular. For instance, bodily exercise universally protects in opposition to despair and nervousness, with little variation in impact measurement throughout geographic areas.15 42 In distinction, alcohol consumption is linked to optimistic psychological well being and decrease charges of despair, nervousness and stress amongst German college students, whereas it’s related to greater charges of those signs in Chinese college students.42 This proof comes from solely two international locations and focuses on a restricted set of way of life behaviours (bodily and psychological exercise, alcohol consumption, smoking, circadian and social regularity). More research throughout a number of international locations, inspecting a broader vary of way of life behaviours, are wanted to make clear each common and country-specific associations.

Both way of life behaviours and psychological well being fluctuate all through college years. Data from the Household, Income and Labour Dynamics in Australia (HILDA) research demonstrated that psychological well being follows a fluctuating course in Australian college students.43 This cohort confirmed that younger college college students skilled a decline in psychological well being from ages 16 to 17, adopted by an enchancment from ages 17 to 18, a decline once more from ages 19 to twenty, after which an enchancment from ages 20 to 21. A UK research equally recognized 4 distinct psychological well being trajectories: persistently high-severity signs, fluctuating signs opposing nationwide developments, fluctuating signs per nationwide developments and persistently low-severity signs.44 Lifestyle behaviours additionally seem to observe various trajectories over time.45 46 However, there’s a lack of potential research investigating the associations between way of life behaviours and psychological well being trajectories in giant cohorts of college college students.

To handle the hole in potential analysis on the connection between a number of way of life behaviours and psychological well being signs in a various worldwide cohort of college college students, the UNIversity college students’ LIFEstyle and Mental well being (UNILIFE-M) research was conceived. The UNILIFE-M cohort is a big, multicentre, worldwide, potential cohort research aiming to offer a complete view of the dynamic relationships between a number of way of life behaviours (together with bodily exercise, sedentary behaviour, food plan, stress administration, sleep, substance use, publicity to inexperienced environments and social assist) and a variety of psychological well being signs (together with depressive, nervousness, manic, obsessive-compulsive, psychotic, attention-deficit/hyperactivity signs, substance abuse and suicidal ideation), both independently or in clusters, amongst college college students worldwide.

Methods

Study design

The UNILIFE-M is a multicentre, worldwide, potential cohort research. The research might be carried out in 67 universities in 28 international locations. Of these, 48 research websites from 19 international locations began knowledge assortment in 2023. The research report follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) pointers.47

Recruitment

The baseline recruitment and assessments will happen in the course of the starting of the educational calendar in 2023 and 2024, with three follow-ups: 1, 2 and three.5 years following the baseline. The recruitment might be closed by 2028. The precise month of the research graduation will fluctuate in keeping with the start of the educational yr in every particular research website. Through a comfort sampling process, college students might be recruited utilizing on-line sources, similar to promoting on social media (eg, Twitter, Instagram and Facebook) and thru college web site/course-specific websites, and direct emails, following related knowledge privateness legal guidelines and insurance policies within the respective international locations and establishments. Newsletters and posters will be fastened on the college partitions with the hyperlink/QR code to the research survey, relying on ethics rules. Lastly, face-to-face invites by flyers had been distributed to college students in gathering locations similar to college eating places, parks, college pupil providers or throughout lectures.

Follow-ups

For the follow-up, individuals might be straight contacted by way of electronic mail, and, each time indicated by the participant and following ethics rules, by way of textual content messages on social media. The use of participant compensation (eg, going right into a prize draw to obtain an e-gift card on completion of surveys at every time level) is permitted however not obligatory for all research websites. Given the breadth of nations and contexts and ethics rules concerned in UNILIFE-M, the usage of participant compensation is to be decided as applicable by every research website.

Participants

Inclusion standards for the research are as follows: (1) aged 16–35 years that features the age vary of these at a better threat for incident psychological well being issues24 and (2) enrolled as a freshman (ie, within the first semester of an undergraduate course) within the 2023 or 2024 educational yr at a taking part UNILIFE-M college. Participants of all programs and fields are eligible.

Outcomes and assessments

The potential research will consider way of life behaviours, psychological well being signs and demographics. Questionnaires not out there within the language of the taking part research websites might be translated and back-translated in keeping with earlier pointers for translating questionnaires.48

Lifestyle

The way of life assessments embody the domains proposed by the American College of Lifestyle Medicine49: food plan and vitamin, substance misuse, bodily exercise, stress administration, restorative sleep, social assist and environmental exposures and might be assessed by two devices, the Short Multidimensional Inventory Lifestyle Evaluation for University Students (U-SMILE)50 and two questions on sedentary behaviour.51

The Short Multidimensional Inventory Lifestyle Evaluation for University Students (U-SMILE)

The U-SMILE is a variation of the self-reported SMILE questionnaire,27 50 developed with pilot knowledge of this cohort, collected between June-December 2022. The unique SMILE scale has 43 gadgets, whereas the U-SMILE contains 24 gadgets evaluating seven domains (food plan and vitamin, substance use, bodily exercise, stress administration, restorative sleep, social assist and environmental exposures). The gadgets ask in regards to the frequency of way of life behaviours in an everyday week over the past month (at all times, typically, seldom or by no means). The unique U-SMILE is a shortened model of the SMILE, as we noticed {that a} vital proportion of individuals dropped out whereas responding to the survey in a pilot pattern of the current research. Scores of the U-SMILE vary from 0 to 96; greater scores imply a more healthy way of life for that area.27 50 The U-SMILE is presently out there in Brazilian Portuguese, Spanish and English and might be translated into all languages of the taking part research websites. The scale has demonstrated acceptable inner consistency (Cronbach’s α=0.73, McDonald’s ω=0.79) within the pilot research pattern.50

Sedentary behaviour

The sedentary behaviour evaluation contains two questions, one measuring the typical period of time spent sitting and one other measuring the time spent mendacity down or in a reclined posture. The scale response was supplied in 5 classes: lower than 3 hours/day; from 3 hours to lower than 6 hours/day; from 6 hours to lower than 8 hours/day; from 8 hours to lower than 12 hours/day; greater than 12 hours/day. The query on sitting time has demonstrated acceptable validity and reliability.51

Mental well being signs

Mental well being signs within the cohort research might be assessed at two ranges. At the primary stage, the Level 1 Cross-Cutting Symptom Measure for Adults Diagnostic,52 proposed by the Diagnostic and Statistical Manual of Mental Disorders – 5 (DSM-5), might be answered by all individuals. Respondents with a optimistic screening on the stage 1 instrument for despair, mania, nervousness, sleep, obsessive and compulsive behaviours, or alcohol/substance abuse might be directed to a stage 2 instrument for that downside. There might be no stage 2 instrument for anger, somatic signs, psychosis, reminiscence issues, dissociation or character, as urged by the cross-sectional DSM-5 software. Attention deficit and hyperactivity signs aren’t assessed within the stage 1 cross-cutting software, so all individuals will reply to the Adult Self-Report Scale (ASRS) – Shortened model at stage 1.53

The DSM-5 Level 1 Cross-Cutting Symptom Measure for Adults

The DSM-5 Level 1 Cross-Cutting Symptom Measure for Adults is a self-reported questionnaire that assesses necessary domains throughout most psychiatric diagnoses.54 The grownup model contains 23 questions that assess 13 psychiatric domains: despair, anger, mania, nervousness, somatic signs, suicidal ideation, psychosis, sleep issues, reminiscence issues, repetitive ideas and behaviours, dissociation, character functioning and substance use. The frequency of experiencing related signs is assessed utilizing a 5-point Likert scale through which individuals will reply about how a lot (or how typically) they’ve been bothered by a given downside in the course of the previous 2 weeks. Responses vary from 0 (none/in no way) to 4 (extreme/almost day-after-day). A rating of two (delicate or a number of days) or higher on any merchandise inside a site is taken into account a optimistic display, aside from substance use, suicidal ideation and psychosis, for which a optimistic display is taken into account when a participant scores 1 (barely or uncommon, lower than a day or two). Subjects with a optimistic screening at stage 1 will reply the extent 2 devices. The DSM-5 Level 1 Cross-Cutting Symptom Measure for Adults has been proven to be a legitimate and dependable software for evaluating psychological well being signs in college college students.55 The cut-off per area and the following stage 2 instrument are seen in table 1.

Table 1

Level 1 cut-offs per area and subsequent stage 2 devices

Depressive signs

Depressive signs might be assessed utilizing the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item self-reported questionnaire that evaluates the presence of depressive signs, outlined in keeping with the DSM standards over the past 2 weeks.56 The PHQ-9 scale confirmed glorious inner reliability (Cronbach’s α=0.89–0.86).57 The scoring ranges from 0 to 27, and better scores point out greater symptom severity. Participants scoring 10 or greater might be thought-about caseness for despair.56 57

Hypomanic/manic signs

Hypomanic/manic signs might be assessed with the hypomania guidelines (HCL-16). The HCL-16 is a 16-item self-report questionnaire that evaluates hypomanic and manic signs, with acceptable reliability (Cronbach’s α=0.77).58 Scores vary from 0 to 16, with greater scores indicating greater severity of manic signs, and scores greater than 7 might be thought-about caseness for manic signs.59

Anxiety signs

Anxiety signs might be assessed with the Generalised Anxiety Disorder questionnaire (GAD-7),60 a 7-item self-report questionnaire evaluating the presence of the core signs of generalised nervousness, with glorious reliability (Cronbach’s α=0.92).60 Scores vary from 0 to 21; greater scores point out elevated nervousness signs and scores equal to or higher than 10 point out caseness for nervousness.60

Sleep disturbances

The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-reported gadgets assessing sleep high quality and disturbances, with good reliability (Cronbach’s α=0.83).61 In the present challenge, we’re utilizing the ten gadgets of the sleep disturbances area. The sum of scores generates a worldwide rating starting from 0 to 21. Higher scores point out sleep disturbances, and scores higher than 5 are caseness for sleep issues.61

Obsessive and compulsive signs

The Obsessive-Compulsive Inventory (OCI-R) contains 18 self-reported gadgets that consider the impression of obsessive and compulsive signs on every day life, with good reliability (Cronbach’s α=0.81).62 The scores vary from 0 to 72, and better scores mirror greater symptom severity, with a rating of 21 or greater indicating caseness for obsessive-compulsive signs.62

Alcohol and substance use

 The use of alcohol and different substances might be evaluated utilizing the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST).63 The ASSIST has eight gadgets assessing the frequency, associated issues, cease makes an attempt and threat and compulsive behaviours related to the usage of tobacco, alcohol, cocaine, marijuana, amphetamine stimulants, sedatives, inhalants, hallucinogens, opioids and different medicine. The present research will assess the frequency of used substances.63 The instrument confirmed acceptable to glorious reliability for every substance (Cronbach’s α starting from 0.73 for tobacco use to 0.92 for alcohol use).63

Attention deficit and hyperactivity signs

Attention deficit and hyperactivity signs might be assessed utilizing the Adult Self-Report Scale (ASRS) for screening for consideration deficit and hyperactivity dysfunction.64 The instrument presents acceptable reliability (Cronbach’s α: 0.63–0.72).64 The shortened model with six gadgets might be used for preliminary screening at stage 1, and people above the cut-off (scoring≥4) will reply the complete scale (stage 2) composed of 12 extra gadgets (ie, 18 gadgets in whole).65 The cut-off for caseness for the complete scale is 16 or greater.

Sociodemographic traits

Participant sociodemographic traits might be assessed, together with age, intercourse, being pregnant (for ladies), gender identification, sexual orientation, top, weight, marital standing, residency, occupation, family revenue, earlier psychological well being analysis and coverings, bodily situations, COVID-19 infections, the college enrolled at and research topic.

University-specific (study-site) data

We will gather particulars, for every research website, on the methods used for participant recruitment (eg, in-person, on-line or each), whether or not participant compensation was used and, if that’s the case, what sort (monetary, educational credit score, vouchers, and so forth) of participant compensation and the whole variety of college students getting into the college at that interval, in addition to the age and gender distribution of enrolled college students.

Sample measurement estimation

For a latent development mannequin, a pattern measurement of n = 150 is ample to reliably detect way of life behaviours and psychological well being trajectory associations (ie, amongst slopes and/or intercepts with a average impact measurement of d=0.5), with an influence = 80% in 4 time factors, and to check associations between trajectories, for an alpha stage of 0.05. According to the present literature,66 we anticipate a 50% attrition fee for the three.5-year follow-up, so the pattern measurement, accounting for attrition, is estimated at n = 300. The pattern measurement corresponds to the minimal per research website.

Statistical analyses

Statistical analyses embody descriptive measures similar to imply and SD and relative and absolute frequencies. Mental well being downside’s prevalence and incidence might be calculated. The associations between trajectories might be examined utilizing latent development curve fashions (LGCMs). Multilevel fashions could also be adopted to regulate the cluster impact of nations and/or universities. All fashions will embody psychological well being issues as categorical and way of life behaviours as steady variables. First, univariate LGCMs might be fitted independently to every psychological well being downside and way of life behaviour as a perform of time. Univariate LGCMs permit for an examination of (1) the preliminary stage of a goal end result (ie, intercept), (2) its fee of change (ie, slope) and the type of this alteration (ie, linear or nonlinear latent development trajectory) and (3) the affiliation between the end result at baseline and its fee of change over time. The intercept of every goal end result (psychological well being signs and way of life behaviours) might be centred at baseline, and a latent development trajectory (ie, linear or nonlinear latent development trajectory) might be examined. Intercepts and slopes of all goal outcomes might be adjusted for baseline age (in years), gender and nation (for the cross-country evaluation). After establishing the latent development trajectories and guaranteeing mannequin slot in univariate LGCMs, cross-domain LGCMs might be carried out to look at the affiliation between every psychological well being symptom trajectory and way of life behaviours. To perceive the connection between particular way of life measured repeatedly and psychopathology measured at three time factors, random intercept cross-lagged panel fashions (RI-CLPM) might be used. This mannequin can differentiate the trait-level relationship between way of life and psychological well being signs and the connection between modifications of their ranges.67

On prime of the parameters estimated in univariate LGCMs, cross-domain LGCMs will assess associations between (1) baseline psychological well being signs and baseline way of life behaviours, (2) baseline way of life behaviours and the speed of change in psychological well being signs and (3) the speed of change in psychological well being signs and the speed of change in way of life behaviours. These fashions might be adjusted for baseline age (in years), intercourse and nation (for the cross-country analyses). Sensitivity LGCM analyses will examine the affiliation between psychological well being signs and way of life within the context of adjustment for potential confounders similar to age and gender. Models together with cross-country knowledge could also be weighted for the pattern measurement in every nation to regulate for the unbalanced variety of research websites per nation. Models together with knowledge from a single nation might be weighted for the achieved pattern measurement in every research website. Missing knowledge might be examined for randomness. To perceive the sample of potential lacking knowledge (lacking fully at random, lacking at random, lacking not at random), and the potential for biased estimates, Little’s MCAR is to be carried out. If vital, the belief that knowledge are lacking fully at random must be rejected. Multivariate imputation by chained equations might be used for multivariate imputations.

The prevalence of psychological well being diagnoses might be corrected by contemplating the sensitivity and specificity of the screening check properties by making use of Bayesian adjustment to appropriate obvious prevalence estimates.68 69

Patient and public involvement

The UNILIFE-M research was codesigned with the goal inhabitants. Participants assisted in growing the research design and instrument choice.

Ethics and dissemination

The UNILIFE-M research procedures adjust to the rules of the Declaration of Helsinki. All individuals are to offer electronically signed knowledgeable consent previous to finishing the survey. Data might be pseudonymised to make sure individuals’ privateness and managed in accordance with knowledge safety rules, together with the Lei Geral de Proteção de Dados (LGPD), as the information might be saved in Brazil. Participants retain the suitable to withdraw at any time. At research websites the place required by native rules, college students reporting psychological well being signs could also be referred to specialised psychological well being providers.

The research acquired moral approval and was registered with the Brazilian Ethics Committee (CAE: 63025822.8.1001.5346). Study websites exterior Brazil relied on the most important challenge to acquire extra institutional ethics approvals, in accordance with native rules. All taking part websites are supported by native, regional or nationwide moral approvals. An in depth listing of the ethics approval numbers for every research website is supplied in online supplemental material.

Results from the UNILIFE-M challenge might be disseminated by scientific publications, displays at scientific conferences, press releases, the overall media and social media. The challenge goals to generate no less than two foremost papers merging knowledge from all of the included international locations/territories/areas, one with cross-sectional knowledge simply after the 2024 baseline assessments and one after research completion, with knowledge from all follow-ups. Additional research dataset analyses (specializing in one or two particular issues, way of life behaviours or international locations/areas) could also be carried out underneath preregistration with the research coordinators.


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