NCT05282537

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 7, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

March 7, 2022

Last Update Submit

July 26, 2024

Conditions

Mental Health Wellness 1Sedentary Behavior

Keywords

AnxietyDepressionBody compositionFood intake

Outcome Measures

Primary Outcomes (3)

  • Depression

    Patient Health Questionnaire (PHQ-7)

    March-December, 2022

  • Physical activity

    International Physical Activity Questionnaire (IPAQ, short form)

    March-December, 2022

  • Body fat percentage

    Air Displacement Plethysmography

    March-December, 2022

Secondary Outcomes (5)

  • Anxiety

    March-December, 2022

  • Sleep Quality

    March-December, 2022

  • Body Mass Index

    March-December, 2022

  • Waist to hip ratio

    March-December, 2022

  • Food intake

    March-December, 2022

Study Arms (1)

In person academic activities group

University students of health sciences area returning to in person academic activities in Mexico. All university students will return to in person academic activities in March, 2022, for that reason a limitation is that it is no possible to have a control group (Nobody is going to continue in virtual academic activities).

Behavioral: In person academic activities

Interventions

In person academic activitiesBEHAVIORAL

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

In person academic activities group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Health Sciences Students
  • Informed consent sign

You may not qualify if:

  • Fail a course by absences
  • No assistance to evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical and Psychology School

Tijuana, California, 22390, Mexico

Location

Related Publications (12)

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 33897499BACKGROUND

  • 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.

    PMID: 32772538BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 31115597BACKGROUND

  • Dos Santos Quaresma MV, Marques CG, Magalhaes 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.

    PMID: 33934054BACKGROUND

  • Martinez-Vazquez SE, Ceballos-Rasgado M, Posada-Velazquez R, Hunot-Alexander C, Nava-Gonzalez EJ, Ramirez-Silva I, Aguilar-Lopez DK, Quiroz-Olguin G, Lopez-Jara B, Delgado-de-la-Cruz C, Huescas-Juarez 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):4256. doi: 10.3390/nu13124256.

    PMID: 34959806BACKGROUND

  • 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.

    PMID: 33449864BACKGROUND

  • Li Y, Wang Y, Jiang J, Valdimarsdottir 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.

    PMID: 32389148BACKGROUND

  • 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.

    PMID: 32574242BACKGROUND

  • 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.

    PMID: 27654506BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

BehaviorMental DisordersBehavioral Symptoms

Study Officials

  • Marco A Hernández-Lepe, Dr.

    Autonomous University of Baja California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

March 14, 2022

Primary Completion

June 10, 2022

Study Completion

December 16, 2022

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations

ME(1)