Cities for Better Health Childhood Obesity Prevention Initiative

• Conditions: Obesity

• Registration Number: NCT06855563
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Study First Posted: 2025-03-04
• Study Start: 2025-04-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

Novo Nordisk; 🇧🇷 Campinas, Brazil

Novo Nordisk Investigational Site; 🇪🇸 Madrid, Spain