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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 13
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Australia
Novo Nordisk Investigational Site
NOT_YET_RECRUITING
Loagan
Brazil
Novo Nordisk
RECRUITING
Campinas
Canada
Novo Nordisk Investigational Site
NOT_YET_RECRUITING
Mississauga
Japan
Novo Nordisk
RECRUITING
Chiba
South Africa
Novo Nordisk Investigational Site
NOT_YET_RECRUITING
Johannesburg
Spain
Novo Nordisk Investigational Site
NOT_YET_RECRUITING
Madrid
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 36000
Treatments
Experimental: Intervention group
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.
No_intervention: Comparison group
The comparison group will be made up of (children in) neighbourhoods where intervention packages are not implemented.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov