Cities for Better Health Childhood Obesity Prevention Initiative

NCT06855563 | Enrolling By Invitation

• 2 other identifiers: DAS-8381U1111-1314-3391
• Study Type: interventional
• Target: 36,000
• Locations: 6 countries
• Sites: 6

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Health-related quality of life (HRQoL), proxied by KIDSCREEN-10 index

  At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)

Other Outcomes (2)

• Physical activity outcomes

  At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)

• Diet outcomes

  At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Comparison group

NO INTERVENTION

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

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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)".
• \- 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (6)

Novo Nordisk Investigational Site

Loagan, Australia

Location

Novo Nordisk - Türkiye

Bangalore, 560066, Brazil

Location

Novo Nordisk Investigational Site

Mississauga, Canada

Location

Novo Nordisk - Türkiye

Bangalore, 560066, Japan

Location

Novo Nordisk Investigational Site

Johannesburg, South Africa

Location

Novo Nordisk Investigational Site

Madrid, Spain

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

ES (1); AU (1); BR (1); JP (1); CA (1); ZA (1)