Clinical trial NCT06855563: Cities for Better Health Childhood Obesity Prevention Initiative
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-03-04
Enrollment: 36000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children living in disadvantaged communities in six cities across Brazil, Canada, France, Japan, South Africa and Spain.

Brief summary: This research project is part of the 'Cities for Better Health Childhood Obesity Prevention Initiative' (CBH COPI), which aims to understand how interventions designed to improve diet and physical activity can impact children's health.


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. In communications asking for consent, parents will be prompted to evaluate whether their children have issues with mental incapacity or language barriers that would preclude adequate understanding or cooperation.

Primary outcomes:
measure: Body mass index z-score (BMI-z) adjusted for age and sex
timeFrame: At baseline, 1st follow-up (10-12 months) and 2nd follow-up (20-24 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Novo Nordisk
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
city: Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: