Childhood obesity is a global problem that is steadily affecting many low- and middle-income countries, particularly in urban settings. The fundamental causes behind the rising levels of childhood obesity are a shift in diet towards increased intake of energy-dense foods that are high in fat and sugars, and decreased levels of physical activity. Current guidelines from the World Health Organization (WHO) recommend that children and adolescents engage in at least 60 min of physical activity in moderate to vigorous intensity on all or most days of the week. However, about 80% of adolescents are estimated not to meet guidelines recommendations worldwide. Several existing interventions targeting reduction in sedentary time of children and adolescents showed efficacy but not effectiveness. Therefore, high quality experimental studies to assess interventions that may provide effectiveness to increase levels of physical activity and/or improve health status in children and adolescents still are needed. Although some variability at the level of interventions may allow to contrast differences and provide models for pragmatic implementation, it is important to reach consistent and comparable outcomes across studies. Indeed, difficulties caused by heterogeneity in outcome measurement are a common issue to systematic reviewers in different research fields. These issues of inconsistency and outcome-reporting bias could be reduced with the development and application of agreed standardised sets of outcomes, known as core outcome sets (COS), that should be measured and reported in all trials for a specific clinical area. Accordingly, we aim to develop a COS related to clinical trials with physical activity interventions for overweight or obese children and adolescents, as well as categorize them into specific domains.
The protocol will be available at https://osf.io/7vaw5/
Fernanda Dias Massierer¹², MSc; Cíntia Ehlers Botton³, ScD; Jessica Pietra da Silva Carvalho¹²; Gisele Cassão², MSc; Angélica Trevisan De Nardi², ScD; Jayne Feter¹², ScD; Andresa Conrado Ignacio¹², MSc; Rodrigo Leal-Menezes¹², MSc; Nórton Luís Oliveira², PhD; Lucineia Orsolin Pfeifer², ScD; Leandro dos Santos¹, ScD; Lucas Porto Santos4, ScD; Larissa Xavier Neves da Silva², ScD; Luciana dos Passos e Silva¹², MSc; Frederico Morais Schwingel²5; Carolina Weingärtner Welter²6; Daniel Umpierre¹², ScD.
Affiliations:
¹ Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil
² LADD Lab, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil
³ Federal University of Ceará (UFC), Fortaleza, Brazil
4 University of São Paulo (USP), São Paulo, Brazil
5 Pontifical Catholic University of Rio Grande do Sul (PUCRS), Porto Alegre, Brazil
6 Federal University of Santa Maria (UFSM), Santa Maria, Brazil
Disease Category: Child health
Disease Name: Obesity , Weight management
Age Range: 5 - 18
Sex: Either
Nature of Intervention: Physical, Exercise
- Clinical experts
- Other
- Patient/ support group representatives
- Researchers
- Consumers (caregivers)
- Consumers (patients)
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Focus group(s)
- Interview
- Systematic review
The list of outcomes for use in an online Delphi survey will be generated from the following sources: 1) An overview of systematic reviews with or without meta-analyses (PROSPERO, CRD42019120334) that will be used as sources of clinical trials; 2) Qualitative interviews with clinicians, physical education professionals, parents/caregivers, and adolescents. The Delphi exercise will involve two rounds in order to achieve consensus among a panel of international stakeholders. All outcomes from the list presented in round 1 will be retained in round 2. Items will be retained from the end of round 2 to the CORE set using stricter cut-off criteria; retained items were rated between 7 and 9 by over 70% of respondents and 1 to 3 by less than 15% by at least one stakeholder group.