ObesityCBH COPINCT06855563
Cities for Better Health Childhood Obesity Prevention Initiative
A study testing Community-based intervention packages in people with Obesity, run by Novo Nordisk A/S at 6 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Obesity
- What is being tested?
- Community-based intervention packages
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36,000 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 30 Apr 2025to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)".
Who cannot join
- 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.
Trial locations and contacts
6 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 6 countries
About this study
Official title: 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.
Read the 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
- Being tested
- Community-based intervention packages
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based intervention packagesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index z-score (BMI-z) adjusted for age and sex
z-score
Measured: 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
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.
Measured: At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start30 Apr 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855563
- Sponsor's protocol ID
- DAS-8381
- Other IDs
- U1111-1314-3391
- Acronym
- CBH COPI
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Novo Nordisk will not receive any data.