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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05282537
Other study ID # UABC2022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 14, 2022
Est. completion date December 16, 2022

Study information

Verified date March 2022
Source Universidad Autonoma de Baja California
Contact Julieta Y Islas-Limón, Dr.
Phone (+52) 664-682-1233
Email yaislas@uabc.edu.mx
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 (World Health Organization, 2020) . 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 (Official Gazette of the Federation, 2020). 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 (Prowse et al., 2021). 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 (Gruber et al., 2021). 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 (Clair et al., 2021). 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 (Liu et al., 2020) as well as changes in diet (dos Santos et al., 2021). 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 witheach person. These levels of physical activity associated with food choices (voluntary or conditioned) have been shown to negatively affect health (Martínez-Vázquez et al., 2021). 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 (Bertrand et al ., 2021). 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 (Bertrand et al., 2021). 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 (Li et al., 2020). 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 (Liu et al., 2020). 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 (Reichenberg et al., 2018).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 325
Est. completion date December 16, 2022
Est. primary completion date June 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Health Sciences Students - Informed consent sign Exclusion Criteria: - Fail a course by absences - No assistance to evaluations

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
In person academic activities
All participants will perform academic activities in person from March to December, 2022

Locations

Country Name City State
Mexico Medical and Psychology School Tijuana California

Sponsors (1)

Lead Sponsor Collaborator
Universidad Autonoma de Baja California

Country where clinical trial is conducted

Mexico, 

References & Publications (12)

Bertrand L, Shaw KA, Ko J, Deprez D, Chilibeck PD, Zello GA. The impact of the coronavirus disease 2019 (COVID-19) pandemic on university students' dietary intake, physical activity, and sedentary behaviour. Appl Physiol Nutr Metab. 2021 Mar;46(3):265-272. doi: 10.1139/apnm-2020-0990. Epub 2021 Jan 15. — View Citation

Clair, R., Gordon, M., Kroon, M., & Reilly, C. (2021). The effects of social isolation on well-being and life satisfaction during pandemic. Humanities and Social Sciences Communications, 8(1), 1-6.

Diario Oficial de la Federación, 2020. Acuerdo por el que se establecen las medidas preventivas que se deberán implementar para la mitigación y control de los riesgos para la salud que implica la enfermedad por el virus SARS-CoV2 (COVID-19). Visitado el 24 de febrero del 2022 en: https://www.dof.gob.mx/nota_detalle.php?codigo=5590339&fecha=24/03/2020.

Dos Santos Quaresma MV, Marques CG, Magalhães ACO, Dos Santos RVT. Emotional eating, binge eating, physical inactivity, and vespertine chronotype are negative predictors of dietary practices during COVID-19 social isolation: A cross-sectional study. Nutrition. 2021 Oct;90:111223. doi: 10.1016/j.nut.2021.111223. Epub 2021 Mar 9. — View Citation

Gruber J, Prinstein MJ, Clark LA, Rottenberg J, Abramowitz JS, Albano AM, Aldao A, Borelli JL, Chung T, Davila J, Forbes EE, Gee DG, Hall GCN, Hallion LS, Hinshaw SP, Hofmann SG, Hollon SD, Joormann J, Kazdin AE, Klein DN, La Greca AM, Levenson RW, MacDonald AW, McKay D, McLaughlin KA, Mendle J, Miller AB, Neblett EW, Nock M, Olatunji BO, Persons JB, Rozek DC, Schleider JL, Slavich GM, Teachman BA, Vine V, Weinstock LM. Mental health and clinical psychological science in the time of COVID-19: Challenges, opportunities, and a call to action. Am Psychol. 2021 Apr;76(3):409-426. doi: 10.1037/amp0000707. Epub 2020 Aug 10. Review. — View Citation

Li Y, Wang Y, Jiang J, Valdimarsdóttir UA, Fall K, Fang F, Song H, Lu D, Zhang W. Psychological distress among health professional students during the COVID-19 outbreak. Psychol Med. 2021 Aug;51(11):1952-1954. doi: 10.1017/S0033291720001555. Epub 2020 May 11. Erratum in: Psychol Med. 2021 Aug;51(11):1960. — View Citation

Liu H, Zhang M, Yang Q, Yu B. Gender differences in the influence of social isolation and loneliness on depressive symptoms in college students: a longitudinal study. Soc Psychiatry Psychiatr Epidemiol. 2020 Feb;55(2):251-257. doi: 10.1007/s00127-019-01726-6. Epub 2019 May 21. — View Citation

Liu J, Zhu Q, Fan W, Makamure J, Zheng C, Wang J. Online Mental Health Survey in a Medical College in China During the COVID-19 Outbreak. Front Psychiatry. 2020 May 13;11:459. doi: 10.3389/fpsyt.2020.00459. eCollection 2020. Erratum in: Front Psychiatry. 2020 Aug 14;11:845. — View Citation

Martínez-Vázquez SE, Ceballos-Rasgado M, Posada-Velázquez R, Hunot-Alexander C, Nava-González EJ, Ramírez-Silva I, Aguilar-López DK, Quiroz-Olguín G, López-Jara B, Delgado-de-la-Cruz C, Huescas-Juárez S, Silva M, Kaufer-Horwitz M. Perceived Diet Quality, Eating Behaviour, and Lifestyle Changes in a Mexican Population with Internet Access during Confinement for the COVID-19 Pandemic: ESCAN-COVID19Mx Survey. Nutrients. 2021 Nov 26;13(12). pii: 4256. doi: 10.3390/nu13124256. — View Citation

Prowse R, Sherratt F, Abizaid A, Gabrys RL, Hellemans KGC, Patterson ZR, McQuaid RJ. Coping With the COVID-19 Pandemic: Examining Gender Differences in Stress and Mental Health Among University Students. Front Psychiatry. 2021 Apr 7;12:650759. doi: 10.3389/fpsyt.2021.650759. eCollection 2021. — View Citation

Reichenberger J, Kuppens P, Liedlgruber M, Wilhelm FH, Tiefengrabner M, Ginzinger S, Blechert J. No haste, more taste: An EMA study of the effects of stress, negative and positive emotions on eating behavior. Biol Psychol. 2018 Jan;131:54-62. doi: 10.1016/j.biopsycho.2016.09.002. Epub 2016 Sep 18. — View Citation

World Health Organization. (2020). Mental health and psychosocial considerations during the COVID-19 outbreak, 18 March 2020 (No. WHO/2019-nCoV/MentalHealth/2020.1.

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Patient Health Questionnaire (PHQ-7) March-December, 2022
Primary Physical activity International Physical Activity Questionnaire (IPAQ, short form) March-December, 2022
Primary Body fat percentage Air Displacement Pletismography March-December, 2022
Secondary Anxiety General Anxiety Disorder 7 Questionnaire (GAD-7) March-December, 2022
Secondary Sleep Quality Pittsburgh Sleep Quality Index (PSQI) March-December, 2022
Secondary Body Mass Index Body Weight and Body Mass Evaluation March-December, 2022
Secondary Waist to hip ratio Waist and hip girths March-December, 2022
Secondary Food intake 24 hour recalls March-December, 2022
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