NCT06855563Enrolling by invitation
Cities for Better Health Childhood Obesity Prevention Initiative
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 36000 (estimated)
- First submitted
- 26 Feb 2025
- Start date
- 30 Apr 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT06855563
What you commit to
- Study type: Interventional
- Planned participants: 36000
- From 30 Apr 2025 to the primary completion date, 31 Dec 2028
- 6 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- 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.
Who the study is looking for
- 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)".
Criteria the registry did not label
- 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:
Age in the registry: 6 years to 13 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Logan | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.