NCT05069090

Brief Summary

This is a longitudinal study of participants from two university communities in Chile. The primary objective is to examine the effect of a regional lockdown on alcohol and tobacco use, using a difference-in-difference analysis to obtain causal estimates of these COVID-19 policies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,038

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 3, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

11 months

First QC Date

October 5, 2021

Last Update Submit

October 6, 2021

Conditions

Keywords

Alcohol DrinkingTobacco useSARS-CoV-2COVID-19EpidemiologyCohort Studies

Outcome Measures

Primary Outcomes (3)

  • Weekly grams of alcohol use

    Consumption of alcohol during the past week measured in grams of pure alcohol

    Last week

  • Frequency of heavy episodic drinking in the past month

    Frequency of consumption of five or more drinks on a single occasion during the past 30 days \[response range 0 to 10 and more times\]

    Last 30 days

  • Quantity of cigarettes per day

    Average daily consumption of cigarettes during the last week

    Last week

Study Arms (2)

Students and academics Universidad La Frontera

The intervention consists of social distancing measures to curb the viral transmission of SARS-CoV-2. The Araucanía region was subject to lockdown in a different moment than the Coquimbo region, creating exogenous variation.

Behavioral: Lockdown and other social distancing measures

Students and academics Universidad Católica del Norte

The intervention consists of social distancing measures to curb the viral transmission of SARS-CoV-2. The Coquimbo region was subject to lockdown in a different moment than the Araucanía region, creating exogenous variation.

Behavioral: Lockdown and other social distancing measures

Interventions

During the study period, the Chilean Ministry of Health established a five-step process for social distancing measures. These ranged from full lockdown (step 1) to almost no restrictions (step 5). Even under full lockdown, citizens were able to obtain permits for essential activities. Citizens had a maximum of two permits per week and were obtained in a virtual station of the Chilean Police Force (Carabineros de Chile).

Students and academics Universidad Católica del NorteStudents and academics Universidad La Frontera

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population are students, academics and administrative personnel of two universities in Chile

You may qualify if:

  • People with study rights either at the undergraduate and postgraduate levels by July 27, 2020 at the Universidad de la Frontera or Universidad Católica del Norte; OR
  • Workers with a full-time or part-time contract with either University, including academics, administrative and assistant personnel; AND
  • Having an email registered in the Human Resource Office of each university

You may not qualify if:

  • People without valid study rights at either university
  • People without a working contract with the university
  • Not having an email registered at the Human Resource Office

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad de la Frontera

Temuco, Región de la Araucanía, Chile

Location

Universidad Católica del Norte

Coquimbo, Chile

Location

Related Publications (14)

  • Jackson SE, Garnett C, Shahab L, Oldham M, Brown J. Association of the COVID-19 lockdown with smoking, drinking and attempts to quit in England: an analysis of 2019-20 data. Addiction. 2021 May;116(5):1233-1244. doi: 10.1111/add.15295. Epub 2020 Nov 26.

    PMID: 33089562BACKGROUND
  • Winkler P, Formanek T, Mlada K, Kagstrom A, Mohrova Z, Mohr P, Csemy L. Increase in prevalence of current mental disorders in the context of COVID-19: analysis of repeated nationwide cross-sectional surveys. Epidemiol Psychiatr Sci. 2020 Sep 29;29:e173. doi: 10.1017/S2045796020000888.

    PMID: 32988427BACKGROUND
  • Daly M, Robinson E. High-Risk Drinking in Midlife Before Versus During the COVID-19 Crisis: Longitudinal Evidence From the United Kingdom. Am J Prev Med. 2021 Feb;60(2):294-297. doi: 10.1016/j.amepre.2020.09.004. Epub 2020 Nov 21.

    PMID: 33234355BACKGROUND
  • Niedzwiedz CL, Green MJ, Benzeval M, Campbell D, Craig P, Demou E, Leyland A, Pearce A, Thomson R, Whitley E, Katikireddi SV. Mental health and health behaviours before and during the initial phase of the COVID-19 lockdown: longitudinal analyses of the UK Household Longitudinal Study. J Epidemiol Community Health. 2021 Mar;75(3):224-231. doi: 10.1136/jech-2020-215060. Epub 2020 Sep 25.

    PMID: 32978210BACKGROUND
  • Rossow I, Bye EK, Moan IS, Kilian C, Bramness JG. Changes in Alcohol Consumption during the COVID-19 Pandemic-Small Change in Total Consumption, but Increase in Proportion of Heavy Drinkers. Int J Environ Res Public Health. 2021 Apr 16;18(8):4231. doi: 10.3390/ijerph18084231.

    PMID: 33923567BACKGROUND
  • Vanderbruggen N, Matthys F, Van Laere S, Zeeuws D, Santermans L, Van den Ameele S, Crunelle CL. Self-Reported Alcohol, Tobacco, and Cannabis Use during COVID-19 Lockdown Measures: Results from a Web-Based Survey. Eur Addict Res. 2020;26(6):309-315. doi: 10.1159/000510822. Epub 2020 Sep 22.

    PMID: 32961535BACKGROUND
  • Nordeck CD, Riehm KE, Smail EJ, Holingue C, Kane JC, Johnson RM, Veldhuis CB, Kalb LG, Stuart EA, Kreuter F, Thrul J. Changes in drinking days among United States adults during the COVID-19 pandemic. Addiction. 2022 Feb;117(2):331-340. doi: 10.1111/add.15622. Epub 2021 Jul 12.

    PMID: 34159674BACKGROUND
  • Glowacz F, Schmits E. Psychological distress during the COVID-19 lockdown: The young adults most at risk. Psychiatry Res. 2020 Nov;293:113486. doi: 10.1016/j.psychres.2020.113486. Epub 2020 Sep 25.

    PMID: 33007682BACKGROUND
  • Callinan S, Smit K, Mojica-Perez Y, D'Aquino S, Moore D, Kuntsche E. Shifts in alcohol consumption during the COVID-19 pandemic: early indications from Australia. Addiction. 2021 Jun;116(6):1381-1388. doi: 10.1111/add.15275. Epub 2020 Oct 18.

    PMID: 33006789BACKGROUND
  • Clare PJ, Aiken A, Yuen WS, Upton E, Kypri K, Degenhardt L, Bruno R, McCambridge J, McBride N, Hutchinson D, Slade T, Mattick R, Peacock A. Alcohol use among young Australian adults in May-June 2020 during the COVID-19 pandemic: a prospective cohort study. Addiction. 2021 Dec;116(12):3398-3407. doi: 10.1111/add.15599. Epub 2021 Jun 24.

    PMID: 34105838BACKGROUND
  • Bartlett L, Brady JJR, Farrow M, Kim S, Bindoff A, Fair H, Vickers JC, Sinclair D. Change in modifiable dementia risk factors during COVID-19 lockdown: The experience of over 50s in Tasmania, Australia. Alzheimers Dement (N Y). 2021 May 13;7(1):e12169. doi: 10.1002/trc2.12169. eCollection 2021.

    PMID: 34027023BACKGROUND
  • Bar-Zeev Y, Shauly M, Lee H, Neumark Y. Changes in Smoking Behaviour and Home-Smoking Rules during the Initial COVID-19 Lockdown Period in Israel. Int J Environ Res Public Health. 2021 Feb 17;18(4):1931. doi: 10.3390/ijerph18041931.

    PMID: 33671203BACKGROUND
  • Bonadio WA, Carron AC, Nelson DB. Serum theophylline concentration in 82 consecutive asthmatic children receiving preadmission theophylline preparation. Pediatr Emerg Care. 1988 Jun;4(2):165. No abstract available.

    PMID: 3380750BACKGROUND
  • Guignard R, Andler R, Quatremere G, Pasquereau A, du Roscoat E, Arwidson P, Berlin I, Nguyen-Thanh V. Changes in smoking and alcohol consumption during COVID-19-related lockdown: a cross-sectional study in France. Eur J Public Health. 2021 Oct 26;31(5):1076-1083. doi: 10.1093/eurpub/ckab054.

    PMID: 33826721BACKGROUND

MeSH Terms

Conditions

COVID-19Alcohol DrinkingTobacco Use

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDrinking BehaviorBehavior

Study Officials

  • Francisca Román, PhD

    Universidad de La Frontera

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 6, 2021

Study Start

June 3, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Deanonymized data is available upon contact with the Principal Investigator

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Immediately
Access Criteria
Collaboration agreement between the interested institution and the Universidad de la Frontera

Locations