Cities for Better Health Childhood Obesity Prevention Initiative

NCT ID: NCT06855563

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 36000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

Requirements for interventions:

The interventions in each country will be multi-level multi-component (MLMC) community-based packages. Their exact features will be tailored to the needs and opportunities of each participating country.

Requirements for study design:

The minimum evaluation study design in terms of robustness is a repeated cross-sectional study with a comparison group. This involves measuring outcomes in a cross-section of children living in the intervention areas of a participating city (i.e. the areas in which the CBH COPI interventions were implemented) and a cross-section of children in similar comparison areas in which the interventions were not implemented, before and after the interventions are introduced. The global analysis will then compare trends in outcomes between intervention- and comparison-group areas. Countries are allowed to implement more robust designs (e.g. incorporating randomisation) if this is feasible.

Each country-level study will collect a set of prespecified indicators at baseline and at two subsequent follow-ups (after 10-12 months, and after 20-24 months). The primary outcome indicator is BMI z-score and the required secondary and exploratory outcomes are defined above. A list of sociodemographic indicators (age, sex, ethnicity, household affluence) is also required to be collected (unless this is not feasible in an individual country for legal reasons).

It is anticipated that 2,000 children in the target population will be recruited per data collection point (baseline, first follow-up, second follow-up) in each country. It is recommended (as the default option) that data are collected from 20 'clusters' (schools) from at least 10 'neighbourhoods' (administrative areas or school catchment areas, depending on the country) over these time points. This set up gives a minimum detectable effect size of Cohen's d = 0.15 in country-level analyses. The sample of neighbourhoods/clusters will be chosen according to feasibility and representativeness considerations in each country.

Local evaluations will be adapted to fit with the social, cultural and policy landscape of each implementing site.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Community-based intervention packages

Intervention Type: 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.

Comparison group

The comparison group will be made up of (children in) neighbourhoods where intervention packages are not implemented.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Community-based intervention packages

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Loagan, , Australia

Novo Nordisk - Türkiye

Bangalore, , Brazil

Novo Nordisk Investigational Site

Mississauga, , Canada

Novo Nordisk - Türkiye

Bangalore, , Japan

Novo Nordisk Investigational Site

Johannesburg, , South Africa

Novo Nordisk Investigational Site

Madrid, , Spain

Countries

France; Australia; Brazil; Canada; Japan; South Africa; Spain

Other Identifiers

U1111-1314-3391

Identifier Type: OTHER

Identifier Source: secondary_id

DAS-8381

Identifier Type: -

Identifier Source: org_study_id