Quality of Life (QOL)NCT07191925
An Evaluation of "Growing Healthy Places: Mississauga"
A study testing Community Co-designed Physical Activity and Diet Intervention Package in people with Quality of Life (QOL) and Physical Activity, run by Brock University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life (QOL), Physical Activity, Diet Quality
- What is being tested?
- Community Co-designed Physical Activity and Diet Intervention Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,900 participants
- Where
- 1 siteCanada
- Study dates
- 16 Oct 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Do the community co-designed interventions improve health-related quality of life of children after one year and two years?
- Do the community co-designed interventions improve the physical activity and eating behaviors of children after one year and two years?
Read more
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
- Being tested
- Community Co-designed Physical Activity and Diet Intervention Package
- Keywords
- health behavior, child health, multi-level, community intervention
- Medical subject headings
- Motor Activity, Obesity, Overweight, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Co-designed Physical Activity and Diet Intervention PackageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receive a community co-designed package of multi-level, multi-component interventions targeting physical activity and diet Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, one-year follow-up, two-year follow-up.
Secondary outcomes (1)
Average daily moderate-to-vigorous physical activity (MVPA)
Daily minutes of moderate-to-vigorous physical activity is measured using a single questionnaire item adapted from the Youth Health - Physical Activity \& Sedentary Behavior Module questionnaire. The question that asks students to indicate the total time range in minutes spent doing moderate or vigorous physical activities the previous day (with examples provided). Provided time intervals are adjusted depending on the age of the participant to facilitate accurate recall. Total MVPA time is calculated by assuming the midpoint of the time interval.
Measured: Baseline, one-year follow-up, two-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start16 Oct 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life (QOL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 4,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Delivery Associates, Ophea, 8 80 Cities, The Behavioural Insights Team
- Responsible party
- Principal investigator, Karen Patte, PhD, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191925
- Sponsor's protocol ID
- REB24-273
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data will be shared with global research collaborators (The Behavioural Insights Team, Oxford University). Novo Nordisk A/S will receive grouped data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of "Growing Healthy Places: Mississauga"
- ClinicalTrials.gov ID
- NCT07191925
- Acronym / sponsor ID
- REB24-273
- Conditions
- Quality of Life (QOL), Physical Activity, Diet Quality, Obesity &Amp; Overweight, Body Esteem, Community
- Keywords
- health behavior, child health, multi-level, community intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,900 participants (estimated)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Delivery Associates, Ophea, 8 80 Cities, The Behavioural Insights Team
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do the community co-designed interventions improve health-related quality of life of children after one year and two years?
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Community Co-designed Physical Activity and Diet Intervention PackageReceive a community co-designed package of multi-level, multi-component interventions targeting physical activity and diet |
| Control Group | No intervention | –Usual school and community practices with no interventions from the study |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Co-designed Physical Activity and Diet Intervention PackageA 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. | Behavioural | Intervention Group |
Primary outcome
Health-related Quality of Life as assessed by KIDSCREEN-10 index
Time frame: Baseline, one-year follow-up, two-year follow-up.
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.
1 secondary outcome
Average daily moderate-to-vigorous physical activity (MVPA)
Time frame: Baseline, one-year follow-up, two-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual data will be shared with global research collaborators (The Behavioural Insights Team, Oxford University). Novo Nordisk A/S will receive grouped data.
Related trials for Quality of Life (QOL)
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Co-designed Physical Activity and Diet Intervention Package in people with Quality of Life (QOL) and Physical Activity, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life as assessed by KIDSCREEN-10 index (time frame: Baseline, one-year follow-up, two-year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.