Cities for Better Health Childhood Obesity Prevention Initiative (CBH COPI)

Cities for Better Health Childhood Obesity Prevention Initiative: A Multi-country Community-based Prevention and Intervention Project Targeting Childhood Obesity Through Diet and Physical Activity Interventions in Disadvantaged Communities of Urban Areas

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Community-based intervention packages

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.

• Study Type: Interventional
• Enrollment (Estimated): 36000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Loagan, Australia
    • Novo Nordisk Investigational Site
• Brazil
  • Bangalore, Brazil, 560066
    • Novo Nordisk - Türkiye
• Canada
  • Mississauga, Canada
    • Novo Nordisk Investigational Site
• Japan
  • Bangalore, Japan, 560066
    • Novo Nordisk - Türkiye
• South Africa
  • Johannesburg, South Africa
    • Novo Nordisk Investigational Site
• Spain
  • Madrid, Spain
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Study Population

Children living in disadvantaged communities in six cities across Brazil, Canada, France, Japan, South Africa and Spain.

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Comparison group; The comparison group will be made up of (children in) neighbourhoods where intervention packages are not implemented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index z-score (BMI-z) adjusted for age and sex	z-score	At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (HRQoL), proxied by KIDSCREEN-10 index	Constructed from KIDSCREEN-10 survey. Each of the 10 measures is coded from 1-5. Sum across 10 measures to create a total score (10-50) and linearly rescale to 0-100 for interpretation.	At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity outcomes	Physical activity outcomes will be elicited via survey instruments adapted from the Core Indicators and Measures of Youth Health - Physical Activity & Sedentary Behavior Module questionnaire. The main physical activity outcomes are: MVPA time (mins per day), physical activity time (mins per day), sedentary time (mins per day), energy expended through physical activity (kcal per day).	At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)
Diet outcomes	Diet outcomes will be measured with an edited version of the Diet Quality Questionnaire (DQQ). The main diet outcome is the Global Dietary Recommendations (GDR) score, and other outcomes include energy intake, nutritional intake and intake of specific food groups.	At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: DAS-8381; U1111-1314-3391 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No