Clinical trial NCT05282537: Health Parameters of University Students After Pandemic Isolation
Official title: Evaluation of Mental Health, Sleep Quality, Level of Physical Activity, Food Intake, and Body Composition Before and After One Year of Face-to-face Academic Activities in University Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Wellness 1
Sedentary Behavior
Keywords: Anxiety
Depression
Body composition
Food intake
Lead sponsor: Universidad Autonoma de Baja California
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 325 undergraduate students form the Medical and Phsychology School of the Autonomous University of Baja California will be invited to participate voluntarily.

Brief summary: The COVID-19 pandemic caused by the SARS-CoV-2 coronavirus represents threats to global health and economy. The high pathogenesis of SARS-CoV-2 extent that the Mexican government declared a national health emergency, agreeing to take extraordinary measures such as the suspension of non-essential work, including the suspension of academic activities at all levels, in order to minimize the dispersion and transmission of the virus and its consequences. Several previously reported quarantine evaluations have shown that psychological stress reactions can arise from the experience of physical and social isolation, so the current global threat of isolation has shaken the usual practices of the general population, including young people, and resulting in the modification of their academic, labor and social dynamics.

The usual behavior in this phenomenon establishes that greater social isolation is associated with less satisfaction with life, higher levels of depression and lower levels of psychological well-being or performance as well as changes in diet. Understanding the factors related to coping with COVID-19 is essential to issue guidance on health in the student population, for that, the present proposal intends to evaluate changes in health parameters derived from the resumption of academic activities in person for a year in university students of health sciences area.

Detailed description: The severe acute respiratory syndrome coronavirus (SARS-CoV-2) caused an outbreak of pneumonia of unknown origin in late December 2019, causing coronavirus disease 19 (COVID-19). After its high contagion capacity, a couple of weeks later the World Health Organization declared COVID-19 an international public security emergency, and by March 2020 it was officially declared a pandemic.

The rapid increase in the number of cases of infection and deaths from COVID-19 forced national governments to take extreme control and prevention measures. In Mexico, the community health strategy was defined in the "National Day of Healthy Distance", where the main guidelines included avoiding inter-personal contagion through confinement, forcing the suspension of all non-essential activities, which included the suspension of academic activities at all levels.

Although the measures that were taken to mitigate the spread of the disease are obtaining favorable results with respect to the transmission of the virus, but the modification of the academic, work, food and social dynamics are having an unprecedented impact on biological, psychological and social health of the population. In this sense, maintaining and promoting the physical and mental health of the population is a challenge that transcends the individual level and demands actions at the local, national and global levels.

Social isolation is a multidimensional event that contemplates both the quantity, as well as the inadequate quality of interactions with other people, including those not only in the family environment, but also at the community level. Social isolation has been studied mainly in older adults derived from their retirement or low mobility, however, the current global threat of isolation has shaken the usual practices of the general population, including young people and resulting in the modification of their academic, labor and social dynamics.

The usual behavior in this phenomenon establishes that greater social isolation is associated with lower life satisfaction, higher levels of depression and lower levels of psychological well-being or performance as well as changes in diet. The invitation to social isolation contemplated in the strategy of the Mexican government promoted the decrease in the level of physical activity in individuals during the last two years, while eating patterns were substantially modified by emotional and economic phenomena associated with each person. These levels of physical activity associated with food choices (voluntary or conditioned) have been shown to negatively affect health.

The lifestyle of university students prior to isolation due to the pandemic was already considered a risk factor for developing chronic non-communicable diseases, due to poor dietary intake, a low level of physical activity and a high level of sedentary lifestyle. Isolation has been shown to decrease physical activity levels and develop poor eating habits in North American university students, specifically in a study that included 125 participants, of which only 16% met the Canadian criteria for physical activity a week before of the pandemic, only 9.6% continued to comply with them during isolation. Furthermore, of the participants who did not meet the physical activity requirements, 55% showed a significant decrease in physical activity levels.

In response to the confinement due to the pandemic, clinically significant results have been reported regarding the presence of mental health problems such as acute stress and anguish in university students of health sciences area. This phenomenon has been attributed to the fact that students of health sciences area have a greater knowledge of COVID-19 (according to the general population), the risks associated with contracting it, symptoms and its possible social impact, for which may be more susceptible to develop mental health problems during the period of confinement.

In addition to confinement and physical inactivity, instability in the national economy contributes substantially to the genesis of mental health effects, such as fear, stress, and anxiety. The interplay between emotions and eating (referred to as emotional eating) has been addressed before, with evidence that changes in food intake are consistently the primary response during altered mental states.

Eligibility criteria: Inclusion Criteria:

* Health Sciences Students
* Informed consent sign

Exclusion Criteria:

* Fail a course by absences
* No assistance to evaluations

Primary outcomes:
measure: Depression
timeFrame: March-December, 2022
measure: Physical activity
timeFrame: March-December, 2022
measure: Body fat percentage
timeFrame: March-December, 2022
Secondary outcomes:
measure: Anxiety
timeFrame: March-December, 2022
measure: Sleep Quality
timeFrame: March-December, 2022
measure: Body Mass Index
timeFrame: March-December, 2022
measure: Waist to hip ratio
timeFrame: March-December, 2022
measure: Food intake
timeFrame: March-December, 2022
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Medical and Psychology School
state: California
Study officials:
affiliation: Autonomous University of Baja California
name: Marco A Hernández-Lepe, Dr.
role: PRINCIPAL_INVESTIGATOR
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