Mental Health Wellness 1NCT05282537
Health Parameters of University Students After Pandemic Isolation
An observational study of Mental Health Wellness 1 and Sedentary Behavior, run by Universidad Autonoma de Baja California at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Sedentary Behavior
- What is being tested?
- In person academic activities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280 participants
- Where
- 1 siteMexico
- Study dates
- 14 Mar 2022to 16 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 325 undergraduate students form the Medical and Phsychology School of the Autonomous University of Baja California will be invited to participate voluntarily.
Who may be able to join
- Health Sciences Students
- Informed consent sign
Who cannot join
- Fail a course by absences
- No assistance to evaluations
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mental Health Wellness 1, Sedentary Behavior
- Being tested
- In person academic activities
- Keywords
- Anxiety, Depression, Body composition, Food intake
- Medical subject headings
- Sedentary Behavior, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In person academic activitiesBehavioural
All participants will perform academic activities in person from March to December, 2022
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: In person academic activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Patient Health Questionnaire (PHQ-7)
Measured: March-December, 2022
Physical activity
International Physical Activity Questionnaire (IPAQ, short form)
Measured: March-December, 2022
Body fat percentage
Air Displacement Plethysmography
Measured: March-December, 2022
Secondary outcomes (5)
Anxiety
General Anxiety Disorder 7 Questionnaire (GAD-7)
Measured: March-December, 2022
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: March-December, 2022
Body Mass Index
Body Weight and Body Mass Evaluation
Measured: March-December, 2022
Waist to hip ratio
Waist and hip girths
Measured: March-December, 2022
Food intake
24 hour recalls
Measured: March-December, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start14 Mar 2022
- Primary completion10 Jun 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Antonio Hernández Lepe, Universidad Autonoma de Baja California
- Investigators
- Marco A Hernández-Lepe, Dr., Principal investigator, Autonomous University of Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282537
- Sponsor's protocol ID
- UABC2022
- Status last verified
- Jul 2024
- First submitted
- 7 Mar 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
World Health Organization. (2020). Mental health and psychosocial considerations during the COVID-19 outbreak, 18 March 2020 (No. WHO/2019-nCoV/MentalHealth/2020.1.
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.
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.
PubMed 33897499Gruber 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.
PubMed 32772538Clair, 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.
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.
PubMed 31115597Dos 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.
PubMed 33934054Martinez-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.
PubMed 34959806Bertrand 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.
PubMed 33449864Li 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.
PubMed 32389148Liu 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.
PubMed 32574242Reichenberger 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.
PubMed 27654506
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05282537
- Acronym / sponsor ID
- UABC2022
- Conditions
- Mental Health Wellness 1, Sedentary Behavior
- Keywords
- Anxiety, Depression, Body composition, Food intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In person academic activities group | – | Behavioral: In person academic activitiesUniversity 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). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 325 undergraduate students form the Medical and Phsychology School of the Autonomous University of Baja California will be invited to participate voluntarily.
Key inclusion criteria (2 listed)
- Health Sciences Students
- Informed consent sign
Key exclusion criteria (2 listed)
- Fail a course by absences
- No assistance to evaluations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In person academic activitiesAll participants will perform academic activities in person from March to December, 2022 | Behavioural | In person academic activities group |
Primary outcome
Depression
Time frame: March-December, 2022
Patient Health Questionnaire (PHQ-7)
Physical activity
Time frame: March-December, 2022
International Physical Activity Questionnaire (IPAQ, short form)
Body fat percentage
Time frame: March-December, 2022
Air Displacement Plethysmography
5 secondary outcomes
Anxiety
Time frame: March-December, 2022
Sleep Quality
Time frame: March-December, 2022
Body Mass Index
Time frame: March-December, 2022
Waist to hip ratio
Time frame: March-December, 2022
Food intake
Time frame: March-December, 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- BackgroundWorld Health Organization. (2020). Mental health and psychosocial considerations during the COVID-19 outbreak, 18 March 2020 (No. WHO/2019-nCoV/MentalHealth/2020.1.
- BackgroundDiario 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: PubMed 33897499Prowse 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.
- Background: PubMed 32772538Gruber 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.
- BackgroundClair, 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: PubMed 31115597Liu 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.
- Background: PubMed 33934054Dos 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.
- Background: PubMed 34959806Martinez-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.
- Background: PubMed 33449864Bertrand 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.
- Background: PubMed 32389148Li 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.
- Background: PubMed 32574242Liu 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.
- Background: PubMed 27654506Reichenberger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco A Hernández-Lepe, Dr. principal investigator
Autonomous University of Baja California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness 1 and Sedentary Behavior, run by Universidad Autonoma de Baja California at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: March-December, 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282537, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.