An Evaluation of "Growing Healthy Places: Mississauga"

NCT07191925 | Active Not Recruiting

• 1 other identifier: REB24-273
• Study Type: interventional
• Target: 4,900
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

health behavior; child health; multi-level; community intervention

Outcome Measures

Primary Outcomes (1)

• Health-related Quality of Life as assessed by KIDSCREEN-10 index

  Health-related quality of life will be proxied by the KIDSCREEN-10 scale, which is developed from 27-item KIDSCREEN-27 scale and assesses health-related quality of life on five dimensions: physical, psychological, autonomy and parent relations, peers and social support, school environment. Each item uses a 5-point Likert-style response based on how strong the respondent is feeling or the frequency of doing / feeling things over the last week. KIDSCREEN instruments were originally designed for ages 8-18 but have been validated in ages 6-18. Item wording is slightly adapted for typical Canadian phrasing. Responses to each item are coded 1-5, items scores are summed, and the total score is linearly transformed to a 0-100 scale. A higher score corresponds to a higher health-related quality of life.

  Baseline, one-year follow-up, two-year follow-up.

Secondary Outcomes (1)

• Average daily moderate-to-vigorous physical activity (MVPA)

  Baseline, one-year follow-up, two-year follow-up

Other Outcomes (22)

• Total daily physical activity time including walking

  Baseline, one-year follow-up, two-year follow-up

• Average daily sedentary time (out-of-school recreational screen time)

  Baseline, one-year follow-up, two-year follow-up

• Estimated energy expenditure

  Baseline, one-year follow-up, two-year follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Community Co-designed Physical Activity and Diet Intervention Package

Control Group

NO INTERVENTION

Usual school and community practices with no interventions from the study

Interventions

Community Co-designed Physical Activity and Diet Intervention Package 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.

Intervention Group

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brock University: lead
• Novo Nordisk A/S: collaborator
• Delivery Associates: collaborator
• Ophea: collaborator
• 8 80 Cities: collaborator
• The Behavioural Insights Team: collaborator

Study Sites (1)

School Board

Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Motor Activity; Obesity; Overweight; Health Behavior

Condition Hierarchy (Ancestors)

Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Health Sciences

Model Details: Clustered intervention: participants within 22 school clusters (10 intervention, 12 control) from 11 unique neighborhoods assigned to either intervention or control for the study duration

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 25, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CA (1)