Age-related Post-lockdown BMI Variations
COVIDLOCKMET01
Different Variations of Intra-familial Body Mass Index Subjected to COVID-19 Lockdown
1 other identifier
observational
298
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedFirst Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedJune 30, 2022
June 1, 2022
2 months
June 23, 2022
June 25, 2022
Conditions
Keywords
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
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
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: 34032283BACKGROUNDDi 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: 34551123BACKGROUNDDi 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: 32513197BACKGROUNDGornicka 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: 32756458BACKGROUNDDunton 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: 32887592BACKGROUNDDi 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.
PMID: 32707724RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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