Lifestyle modification of adolescents from different countries during confinement by Covid-19

ISRCTN ISRCTN14025343
DOI https://doi.org/10.1186/ISRCTN14025343
Secondary identifying numbers IMD PI-043
Submission date
29/05/2020
Registration date
02/07/2020
Last edited
04/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Alberto Davalos
Scientific

Laboratory of Epigenetics of Lipid Metabolism, IMDEA Food Institute
Ctra. de Canto Blanco, 8
Madrid
28049
Spain

ORCiD logoORCID ID 0000-0001-5709-6443
Phone +34 912796985
Email alberto.davalos@imdea.org
Dr María B. Ruiz-Roso
Scientific

Laboratory of Epigenetics of Lipid Metabolism, IMDEA Food Institute
Ctra. de Canto Blanco, 8
Madrid
28049
Spain

Phone +34 917 27 81 00
Email belen.ruizroso@imdea.org

Study information

Study designQuantitative cross-sectional study with convenience sampling
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Internet/virtual
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleObservational study of lifestyle modification of adolescents from different countries during confinement by Covid-19
Study acronymNutriCoronaTeen
Study objectivesDue 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(s)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
Health condition(s) or problem(s) studiedHealthy volunteers
InterventionThe 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 typeOther
Primary outcome measure1. 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 measuresMeasured 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 study start date09/04/2020
Completion date19/06/2020

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
SexBoth
Target number of participantsAt least 100 per country (at least 500 in total)
Total final enrolment820
Key inclusion criteria1. 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
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment16/04/2020
Date of final enrolment19/06/2020

Locations

Countries of recruitment

  • Brazil
  • Chile
  • Colombia
  • Italy
  • Spain

Study participating centres

Madrid Institute for Advanced Studies (IMDEA) - Food
Laboratory of Epigenetics of Lipid Metabolism
Ctra. de Canto Blanco, 8.
Madrid
28049
Spain
Universidad de Concepción
Centro Vida Saludable
Victoria 580
Barrio Universitario
Concepción
4070386
Chile
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
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
University of Padova.
Department of Molecular Medicine
Via Gabelli, 63
Padua
35121
Italy

Sponsor information

IMDEA Food
Research organisation

Laboratory of Epigenetics of Lipid Metabolism
Ctra. de Canto Blanco, 8
28049 - Madrid
Madrid
28049
Spain

Phone +34 912796985
Email alberto.davalos@imdea.org
Website https://www.alimentacion.imdea.org/epigenetics-lipid-metabolism-group
ROR logo "ROR" https://ror.org/04g4ezh90

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/07/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 17/06/2020 04/07/2020 Yes No
Results article results 30/07/2020 04/08/2020 Yes No

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.