Age-related Post-lockdown BMI Variations (COVIDLOCKMET01)

June 25, 2022 updated by: piero portincasa, University of Bari

Different Variations of Intra-familial Body Mass Index Subjected to COVID-19 Lockdown

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

The pandemic diffusion of the new severe acute respiratory syndrome coronavirus SARS-CoV-2 caused major impacts on health, economy, and social dynamics. During the first wave of the pandemic, besides the direct effect of the COVID-19 disease, staying at home has promoted, in non-infected subjects, sedentary lifestyle, negative psychological consequences, restriction in spending, and accumulation of long-life food with limited use of fresh foods, such as seasonal fruit and vegetables. As a consequence, the lockdown has represented a population-based, inedited model of increased metabolic risk in all age groups, able to affect the health status in a relatively short period.

Previous studies reported negative metabolic outcomes of the lockdown both adults and in children. These effects have been linked with altered eating behavior and lifestyle, with a significant reduction in physical activity, and with an impairment of psychological health. However, these studies were based on self-reported questionnaires, which may lead to misreporting of data. Furthermore, the reported effects on body size variations have been generally explored, at a population level, in separate age groups, and the existence of possible intra-familial, distinct outcomes in adults and children sharing the same critical event and living environment have been scarcely explored.

Although several studies have shown the impact of Lockdown on metabolic status, potential intra-familial, specific effects in adults and children sharing the same socio-economic, cultural level and living habits have been scarcely explored. In the present study The investigators had the chance to dissect the intra-familial impact of two month of lockdown due to COVID-19 pandemic on BMI in a large cohort of non-infected parents and in their children/adolescents.

Primary objective: to characterize changes of dietary habits, lifestyle and anthropometric indices in parents and in their children during lockdown.

The investigators designed an observational, prospective study using a validated questionnaire to profile adults (parents) and their children living in Apulian 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.

Inclusion Criteria:

  • Subjects able to sign the Informed Consent
  • Subjects who were in Lockdown
  • For children, the inclusion criteria were: (i) age between 5 and 18 years; (ii) absence of ongoing therapies.

Exclusion Criteria:

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

The investigators considered that a sample of 149 parents and 149 children/adolescents gives sufficient power to detect significant differences over time regarding BMI, physical activity and metabolic status during COVID-19 lockdown

The investigators designed an observational study using a validated questionnaire to profile adults (parents) and their children living in Apulian region (Southern Italy) during the lockdown imposed in the first wave of the pandemic.

Study Type

Observational

Enrollment (Actual)

298

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BA
      • Bari, BA, Italy, 70124
        • Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • Subjects able to sign the Informed Consent
  • Subjects who were in Lockdown
  • For children, the inclusion criteria were: (i) age between 5 and 18 years; (ii) absence of ongoing therapies.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of COVID-19 lockdown on changes of anthropometric indices
Time Frame: 2 months
To characterize changes of dietary habits, lifestyle and anthropometric indices in parents and in their children during lockdown.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

July 15, 2020

Study Completion (Actual)

September 15, 2020

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 25, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-LOCKDOWN MET 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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