An Evaluation of "Growing Healthy Places: Mississauga"

NCT ID: NCT07191925

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2027-11-30

Brief Summary

The goal of this intervention study is to learn if community co-designed activities to improve diet and physical activity can impact the health of children ages 6-13 in Mississauga, Canada. The main questions it aims to answer are:

1. Do the community co-designed interventions improve health-related quality of life of children after one year and two years?

2. Do the community co-designed interventions improve the physical activity and eating behaviors of children after one year and two years?

Ten intervention and 12 control schools will take part in this study. The schools were recruited from the Mississauga area using an application process. Selection and group assignment involved a multi-stage process with initial randomization followed by manual adjustment (to balance groups on key observable characteristics and respond to stakeholder concerns about spillovers and implementation feasibility).

Researchers will compare students in schools that receive the interventions to students in schools that receive no interventions to see if the interventions improve health-related quality of life, increase physical activity and improve eating behaviors.

Participants will:

• attend participating elementary or middle schools (in either intervention neighborhoods or control neighborhoods)
• complete an anonymous questionnaire about their wellbeing, physical activity, and eating behaviors at baseline, after one year, and after two years
• potentially participate in school and community programs (if in an intervention school neighborhood)

Conditions

Quality of Life (QOL); Physical Activity; Diet Quality; Obesity &Amp; Overweight; Body Esteem; Community

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Receive a community co-designed package of multi-level, multi-component interventions targeting physical activity and diet

Group Type: EXPERIMENTAL

Community Co-designed Physical Activity and Diet Intervention Package

Intervention Type: BEHAVIORAL

A package of 4-6 diet and physical activity interventions selected from a long-list of potential interventions and adapted to the unique school and neighborhood context via consultation with community stakeholders. Intervention packages are multi-level (i.e. targeting at least two of individual, external and structural environments), target elements of both diet and physical activity, and are health equity oriented in terms of both access and improvement. Long-list potential interventions include items related to school intramural programming, active transport, health education, community recreational programming, and structural/public space design improvements.

Control Group

Usual school and community practices with no interventions from the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Community Co-designed Physical Activity and Diet Intervention Package

A package of 4-6 diet and physical activity interventions selected from a long-list of potential interventions and adapted to the unique school and neighborhood context via consultation with community stakeholders. Intervention packages are multi-level (i.e. targeting at least two of individual, external and structural environments), target elements of both diet and physical activity, and are health equity oriented in terms of both access and improvement. Long-list potential interventions include items related to school intramural programming, active transport, health education, community recreational programming, and structural/public space design improvements.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Informed consent obtained by the child's parent or legal guardian before any study-related activities
• Aged 6-13 years (both 6 and 13 allowed) at the time of signing consent
• Enrolled in Grades 3-8 in one of the participating schools at the time of data collection

Exclusion Criteria

• Parent(s) or legal guardians do not provide fully informed consent
• Parent(s) or legal guardians withdraw their consent for their child participating in the research
• Child does not agree to participate on the data collection day

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Delivery Associates

UNKNOWN

Sponsor Role: collaborator

Ophea

UNKNOWN

Sponsor Role: collaborator

8 80 Cities

UNKNOWN

Sponsor Role: collaborator

The Behavioural Insights Team

OTHER

Sponsor Role: collaborator

Brock University

OTHER

Sponsor Role: lead

Responsible Party

Karen Patte, PhD

Associate Professor, Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School Board

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

REB24-273

Identifier Type: -

Identifier Source: org_study_id