Clinical trial

Cities for Better Health Childhood Obesity Prevention Initiative

Invitation only · Not applicable · 6 countries · Registry ID NCT06855563

Invitation onlyNot applicableInterventional

What this study is about

This research project is part of the 'Cities for Better Health Childhood Obesity Prevention Initiative' (CBH COPI). The objective of the CBH COPI initiative is to develop, implement, and evaluate the effectiveness of a package of prevention interventions in five cities to promote healthy eating, physical activity, a positive health-related quality of life, and a reduction in rates living with overweight or obesity among children aged 6-13 years in six cities across Australia, Brazil, Canada, Japan, South Africa and Spain. The primary research objective of CBH COPI is to estimate the impact of the intervention packages on the average BMI of the target population of children across the participating countries, at one-year and two-year follow-ups. The secondary research objective is to estimate the impact of the intervention packages on average health-related quality of life (HRQoL) at the same time points. Exploratory aims include estimating the impact of the packages on behaviours related to physical activity and diet.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 13 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

To be eligible to be involved in data collection, children must attend the 'clusters' (schools) that are part of the study. In each cluster, country evaluation teams will try to ensure that the sample of children selected for data collection is representative of the total population in that cluster (e.g. the full list of students ages 6-13 who go to that school) - in particular, with respect to age and sex. All countries will also use the inclusion and exclusion criteria below for children in the study: Inclusion Criteria: * Informed consent obtained by the child's parent or legal guardian before any study-related activities (where study-related activities are defined as any procedure related to recording of data according to the protocol). The specific consent form and procedures for obtaining consent will be outlined by the local project partner. * Aged 6-13 years (both 6 and 13 allowed) at the time of signing consent. Deviations from or exceptions to this procedure must be agreed between the research team in the relevant country and the GIP, and are subject to the relevant local ethical amendment procedure. The exception must be due to a scientifically sound rationale and must further consider the following guiding principles: "it must be measurable, it must have marginal utility, it must be meaningful (i.e. linked to the ultimate impact and the primary and/or secondary objective)". Exclusion Criteria: \- Children will be excluded from the study if their parent(s) do not provide fully informed consent for their data to be collected, if during the measurement day they do not agree to participate, or if the child's parent(s) or legal guardian(s) withdraw their consent for their child participating in the research at any point in line with processes described in local informed consent forms.

Treatments and study arms

Community-based intervention packages

Behavioral

Community-based intervention packages * Intervention packages are expected to consist of multiple specific activities tailored to the local context. All intervention packages will be designed to be (i) multi-level (i.e. targeting at least two of individual, external and structural environments), (ii) multi-component (i.e. targeting both healthy diet and physical activity), (iii) co-created with local communities in which they are implemented and (iv) health equity oriented in terms of both access and improvement. The exact package of interventions will differ by country and is expected to evolve pragmatically over time. * The intervention group in each country will be made up of (children in) neighbourhoods where intervention packages are implemented.