NCT05430542

Brief Summary

The COVID-19 lockdown has represented an unedited model of increased metabolic risk in all age groups, due to negative changes in dietary habits, physical activity, lifestyle. These effects have been generally explored at a population level in distinct age groups. Potential intra-familial, specific effects in adults and children sharing the same socio-economic, cultural level and living habits have been scarcely explored. The investigators aimed to extend the previous observations concerning anthropometric data at the intra-familial level. In particular, The investigators prospectively characterized the variations in lifestyle habits and related outcomes over a 2 two months COVID-19 lockdown period, exploring both parents and their children. A cohort of 149 couple parent/children were prospectively enrolled. By a validated questionnaire The investigators explored changes of Body Mass Index (BMI) and individual lifestyle during a 2-month lockdown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

Study Start

First participant enrolled

May 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 23, 2022

Last Update Submit

June 25, 2022

Conditions

Keywords

Body mass indexCOVID-19DietLockdownOverweight and ObesityPhysical activitySedentary behavior

Outcome Measures

Primary Outcomes (1)

  • Effects of COVID-19 lockdown on changes of anthropometric indices

    To characterize changes of dietary habits, lifestyle and anthropometric indices in parents and in their children during lockdown.

    2 months

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators designed an observational, prospective study using a validated questionnaire to profile adults (parents) and their children living in Apulia region (Southern Italy) during the lockdown imposed in the first wave of the pandemic. Overall, 149 parents and 149 children/adolescents are recruited. The study period is 2 months (15 May 2020 - 15 July 2020). Enrolled in the protocol are accompanying parents and children from the outpatient clinics of the Pediatric Unit, in collaboration with the staff of the Unit of Internal Medicine, University of Bari. Participation in the study is on voluntary basis. Children enter the study after parental written informed consent. Adults also provide written informed consent.

You may qualify if:

  • Subjects able to sign the Informed Consent
  • Subjects who were in Lockdown

You may not qualify if:

  • Subjects not able to provide informed consent
  • SARS-CoV-2 infection
  • Diagnosis of organic diseases including neoplastic, severe cardiovascular diseases, renal insufficiency, psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"

Bari, BA, 70124, Italy

Location

Related Publications (6)

  • Shanmugam H, Di Ciaula A, Di Palo DM, Molina-Molina E, Garruti G, Faienza MF, vanErpecum K, Portincasa P. Multiplying effects of COVID-19 lockdown on metabolic risk and fatty liver. Eur J Clin Invest. 2021 Jul;51(7):e13597. doi: 10.1111/eci.13597. Epub 2021 May 25.

    PMID: 34032283BACKGROUND
  • Di Ciaula A, Krawczyk M, Filipiak KJ, Geier A, Bonfrate L, Portincasa P. Noncommunicable diseases, climate change and iniquities: What COVID-19 has taught us about syndemic. Eur J Clin Invest. 2021 Dec;51(12):e13682. doi: 10.1111/eci.13682. Epub 2021 Sep 29.

    PMID: 34551123BACKGROUND
  • Di Renzo L, Gualtieri P, Pivari F, Soldati L, Attina A, Cinelli G, Leggeri C, Caparello G, Barrea L, Scerbo F, Esposito E, De Lorenzo A. Eating habits and lifestyle changes during COVID-19 lockdown: an Italian survey. J Transl Med. 2020 Jun 8;18(1):229. doi: 10.1186/s12967-020-02399-5.

    PMID: 32513197BACKGROUND
  • Gornicka M, Drywien ME, Zielinska MA, Hamulka J. Dietary and Lifestyle Changes During COVID-19 and the Subsequent Lockdowns among Polish Adults: A Cross-Sectional Online Survey PLifeCOVID-19 Study. Nutrients. 2020 Aug 3;12(8):2324. doi: 10.3390/nu12082324.

    PMID: 32756458BACKGROUND
  • Dunton GF, Do B, Wang SD. Early effects of the COVID-19 pandemic on physical activity and sedentary behavior in children living in the U.S. BMC Public Health. 2020 Sep 4;20(1):1351. doi: 10.1186/s12889-020-09429-3.

    PMID: 32887592BACKGROUND
  • Di Renzo L, Gualtieri P, Cinelli G, Bigioni G, Soldati L, Attina A, Bianco FF, Caparello G, Camodeca V, Carrano E, Ferraro S, Giannattasio S, Leggeri C, Rampello T, Lo Presti L, Tarsitano MG, De Lorenzo A. Psychological Aspects and Eating Habits during COVID-19 Home Confinement: Results of EHLC-COVID-19 Italian Online Survey. Nutrients. 2020 Jul 19;12(7):2152. doi: 10.3390/nu12072152.

MeSH Terms

Conditions

Metabolic SyndromeOverweightObesityCOVID-19Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 24, 2022

Study Start

May 15, 2020

Primary Completion

July 15, 2020

Study Completion

September 15, 2020

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations