Condition category
Not Applicable
Date applied
29/05/2020
Date assigned
02/07/2020
Last edited
04/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Due to the confinement (due to COVID-19), it is likely that families have more time to cook and could improve their eating habits. Although it should be kept in mind that this would not necessarily increase the quality of the diet. Indeed, families could also consume a higher caloric intake because they spend more time at home. On the other hand, confinement would worsen physical activity habits in adolescents. Based on this, our hypothesis is that confinement may change the lifestyle of adolescents. These new habits could be fixed and have an impact on their health at adult life. For this reason, it is important to generate studies that analyse their eating and physical activity behaviors. We aimed to describe the lifestyle of adolescents in Spain, Brazil, Chile, Colombia and Italy during confinement by COVID-19, and the possible changes in their dietary and physical activity habits due to this situation compared to those observed before confinement.

Aim: Understanding lifestyle habits of adolescents during social confinement will help public health authorities to reshape their reactions to future, unavoidable confinements.

Who can participate?
The study population comprised adolescents residing in Brazil, Chile, Colombia, Spain and Italy, who filled out an online questionnaire. To be included in the research, the adolescent had to be aged between 10 and 19 years old and 11 months; present no food restrictions and provide an authorization to participate in the study.

What does the study involve?
The study involve filling a self-administered online survey questionnaire that is divided into modules: sociodemographic characteristics, dietary practices before and during confinement, and lifestyle before and during confinement.

What are the possible benefits and risks of participating?
The main benefit of understanding the adolescents’ nutrition and physical activity behavior during COVID-19 lockdown is the possible development of future policies. Indeed, this information will help public health authorities reshape future policies on adolescents’ s nutritional and physical activity recommendations, in preparation for future pandemics.
No risk for participants are envisioned as the study only involve filling an online survey.

Where is the study run from?
Madrid Institute for Advanced Studies (IMDEA) - Food (Spain)

When is the study starting and how long is it expected to run for?
April 2020 to June 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Alberto Davalos, alberto.davalos@imdea.org
Dr María B. Ruiz-Roso, belen.ruizroso@imdea.org

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alberto Davalos

ORCID ID

http://orcid.org/0000-0001-5709-6443

Contact details

Laboratory of Epigenetics of Lipid Metabolism
IMDEA Food Institute
Ctra. de Canto Blanco
8
Madrid
28049
Spain
+34 912796985
alberto.davalos@imdea.org

Type

Scientific

Additional contact

Dr María B. Ruiz-Roso

ORCID ID

Contact details

Laboratory of Epigenetics of Lipid Metabolism
IMDEA Food Institute
Ctra. de Canto Blanco
8
Madrid
28049
Spain
+34 917 27 81 00
belen.ruizroso@imdea.org

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IMD PI-043

Study information

Scientific title

Observational study of lifestyle modification of adolescents from different countries during confinement by Covid-19

Acronym

NutriCoronaTeen

Study hypothesis

Due to the confinement (Covid-19), it is likely that families have more time to cook and could improve their eating habits. Although it should be kept in mind that this would not necessarily increase the quality of the diet. Indeed, families could also consume a higher caloric intake because they spend more time at home. On the other hand, confinement would worsen physical activity habits in adolescents. Based on this, our hypothesis is that confinement may change the lifestyle of adolescents. These new habits could be fixed and have an impact on their health at adult life. For this reason, it is important to generate studies that analyses their eating and physical activity behaviors.

Ethics approval

1. Approved 06/05/2020, Comité Ética de Investigación, Fundación IMDEA Alimentación (Ctra. de Canto Blanco, 8. 28049 - Madrid, Spain; +34 917278100; cei.alimentacion@imdea.org), ref: IMD PI-043
2. Approved 16/04/2020, URFJ – Instituto de Puericultura e Pediatria Martagão Gesteira da Universidade Federal do Rio de Janeiro (Rua Bruno Lobo 50 - Ilha do Fundão . Rio de Janeiro-RJ; Brazil; +55 (21)2590-3842; pesquisa@ippmg.ufrj.br), ref: CAAE 30783320.7.0000.5264
3. Approved 15/04/2020, Comité de Ética, Bioética y Bioseguridad de la Dirección de Investigación y Creación Artística de la Vicerrectoría de Investigación y Desarrollo de la Universidad de Concepción (4070386 Concepción, Chile, presidenta, Dra. María Andrea Rodríguez Tastets, +56 (41)2204302; secrevrid@udec.cl), ref: CEBB 646-2020
4. Approved 21/04/2020, Comité de Ética en Investigaciones de la Universidad de Cartagena (Centro - Cra. 4 No. 38-40, Claustro de la Merced, Cartagena de Indias, D.T. y C. - Colombia; +576642663; comítedeetica@unicartagena.edu.co), ref: Acta nº 134
5. Università Degli Studi di Padova (HIT Ethical Committee, Human Inspired Technology Research Centre, Via Luzzatti, 4 - 35121 Padova, Italy; +39 049 827 5796; ethical.hit@unipd.it), ref: 33035 22 04 2020

Study design

Quantitative cross-sectional study with convenience sampling

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Healthy volunteers

Intervention

The study population comprises adolescents residing in Brazil, Chile, Colombia, Spain and Italy.

Data collection will be carried out through a structured questionnaire (e-survey). The questionnaire will be self-administered, and categorized into modules by subject: sociodemographic characteristics, dietary and lifestyle practices. The invitation to participate in the survey will be made by social media (Facebook, Instagram and Whatsapp).

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Lifestyle of adolescents during confinement by COVID-19 measured using novel online survey at a single timepoint
2. Changes in dietary and physical activity habits measured using novel online survey at a single timepoint

Secondary outcome measures

Measured using novel online survey at a single timepoint:
1. Sociodemographic profile of adolescents (income, sex, age, number of people in the family and schooling).
2. Food consumption
3. Lifestyle habits (screen time, mobile phone use, and computer use) and physical activity

Overall trial start date

09/04/2020

Overall trial end date

19/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adolescents residing in Brazil, Chile, Colombia, Spain and Italy aged between 10 years and 19 years 11 months
2. No food restrictions
3. Provide an authorization to participate in the study

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

At least 100 per country (at least 500 in total)

Total final enrolment

820

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

16/04/2020

Recruitment end date

19/06/2020

Locations

Countries of recruitment

Brazil, Chile, Colombia, Italy, Spain

Trial participating centre

Madrid Institute for Advanced Studies (IMDEA) - Food
Laboratory of Epigenetics of Lipid Metabolism Ctra. de Canto Blanco, 8.
Madrid
28049
Spain

Trial participating centre

Universidad de Concepción
Centro Vida Saludable Victoria 580 Barrio Universitario
Concepción
4070386
Chile

Trial participating centre

Universidade Federal do Rio de Janeiro.
Instituto de Nutrição Josué de Castro Av. Carlos Chagas Filho, 373 bloco J 2 andar Cidade Universitária da Universidade Federal do Rio de Janeiro
Rio de Janeiro
21941-902
Brazil

Trial participating centre

University of Cartagena
Research Group in Innovation and Agricultural and Agroindustrial Development Avenida del Consulado, calle 30 No. 39 B - 192
Cartagena
48-152
Colombia

Trial participating centre

University of Padova.
Department of Molecular Medicine Via Gabelli, 63
Padua
35121
Italy

Sponsor information

Organisation

IMDEA Food

Sponsor details

Laboratory of Epigenetics of Lipid Metabolism
Ctra. de Canto Blanco
8
28049 - Madrid
Madrid
28049
Spain
+34 912796985
alberto.davalos@imdea.org

Sponsor type

Research organisation

Website

https://www.alimentacion.imdea.org/epigenetics-lipid-metabolism-group

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Dra. Belen Ruiz-Roso (belen.ruizroso@imdea.org), raw data of the survey (Excel file) available from August 2020 and for 12 months. Sharing will be based on scientific collaboration and consent from the PI of each research group (country) will be obtained prior sharing. Data is completely anonymized as no personal information was recorded. Restrictions may apply.

Intention to publish date

30/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/32560550/ (added 04/07/2020)
2020 results in https://doi.org/10.3390/nu12082289 (added 04/08/2020)

Publication citations

Additional files

Editorial Notes

04/08/2020: Publication reference added. 04/07/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 11/06/2020: Trial’s existence confirmed by Universidad de Concepcion.