Core Outcome Measures in Effectiveness Trials

Core outcomes in children and adolescents with overweight/obesity exposed to physical activity interventions

General Information

Summary:
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/

Contributors:
Dr Cíntia E. Botton- Exercise Pathophysiology Research Laboratory and National Institute of Science and Technology for Health Technology Assessment (IATS), Brazil.
Ms Angélica T. De Nardi- Exercise Pathophysiology Research Laboratory, Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul, Brazil.
Ms Lucinéia O. Pfeifer- Exercise Pathophysiology Research Laboratory, Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul, Brazil.
Mr Lucas P. Santos- Exercise Pathophysiology Research Laboratory, Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul, Brazil.
Dr Leandro dos Santos- Graduate Program of Public Health, Universidade Federal do Rio Grande do Sul, Brazil.
Ms Larissa X. N. da Silva- Exercise Pathophysiology Laboratory and National Institute of Science and Technology for Health Technology Assessment (IATS), Brazil.
Dr Nórton L. Oliveira- Exercise Pathophysiology Laboratory and Postgraduate Research Group at the Hospital de Clínicas de Porto Alegre.
Dr Daniel Umpierre- Exercise Pathophysiology Research Laboratory, Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul, Brazil.


Further Study Information

Current Stage:
Ongoing
Date:
July 2019 - 2020
Funding source(s):
The study will be supported by Fundo de Incentivo à Pesquisa e Eventos of Hospital de Clínicas de Porto Alegre (FIPE-HCPA, Brazil) and by National Institute of Science and Technology for Health Technology Assessment (IATS, Brazil).

Health Area

Disease Category
Child health

Disease Name
Obesity
Weight management

Target Population

Age Range
5 - 18

Sex
Either


Nature / type of Intervention
Exercise
Physical

Method(s)

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.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Other
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.