Community Intervention for Healthy Eating and Physical Activity

Overseen By Katelyn Battista, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Brock University

Disqualifiers: Consent withdrawal, Child non-agreement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if activities designed with community input can help children in Mississauga, Canada, improve their diet and physical activity. Researchers seek to discover if these activities can enhance the kids' health-related quality of life and improve their eating and exercise habits over one and two years. The study compares children attending schools with these programs to those in schools without them. Children in grades 3-8 at specific schools in the Mississauga area might be suitable for this trial. As an unphased trial, this study provides a unique opportunity for children to benefit from community-driven health programs and contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for children?

Research has shown that programs designed with community input to improve diet and exercise are generally safe and well-received. Co-design involves working closely with the community to create activities that meet their needs. Studies have found these programs can be successfully implemented in various locations, often leading to increased physical activity and improved social connections.

While specific data from clinical trials on children in this area is lacking, similar studies have not reported any major negative effects. This suggests these programs are likely safe for children. They focus on creating environments that encourage healthy habits, such as providing safe and welcoming places to play and exercise. Overall, these programs aim to support healthier lifestyles without introducing any known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Co-designed Physical Activity and Diet Intervention Package because it takes a fresh, holistic approach to promoting healthy lifestyles. Unlike traditional methods that might focus narrowly on either diet or exercise, this intervention combines multiple components, targeting both physical activity and dietary habits simultaneously. Moreover, it is co-designed with input from the community, ensuring that the interventions are culturally relevant and tailored to the specific needs of the population. This participatory approach not only empowers the community but also increases the likelihood of sustainable, long-term lifestyle changes.

What evidence suggests that this community co-designed intervention is effective for improving children's health?

Research has shown that when communities help design health programs, children's physical activity and eating habits improve. In this trial, participants in the intervention group will receive a community co-designed package of multi-level, multi-component interventions targeting physical activity and diet. Studies have found that such programs can increase the number of steps children take each day and the time they spend being active. Programs focusing on changing lifestyle habits can quickly improve health behaviors. These co-designed programs also foster social connections, benefiting overall well-being. Involving communities in creating these programs can lead to real improvements in children's health and lifestyle. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 6-13 in Mississauga, Canada who are enrolled in grades 3-8 at participating schools. Parents or guardians must give consent. It's designed to see if special programs can improve kids' health by promoting physical activity and healthy eating.

Inclusion Criteria

I am between 6 and 13 years old.

I am a student in grades 3-8 at a participating school.

My child's guardian has given consent for study-related activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Community co-designed activities to improve diet and physical activity are implemented in intervention schools

2 years

Continuous engagement through school programs

Follow-up

Participants are monitored for health-related quality of life, physical activity, and eating behaviors

2 years

Questionnaires at baseline, one-year, and two-year follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Community Co-designed Physical Activity and Diet Intervention Package

Trial Overview Researchers are testing a package of activities co-designed with the community aimed at improving diet and exercise among schoolchildren. They'll compare kids from schools with these programs to those without, looking at quality of life, physical activity, and eating habits over two years.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

Usual school and community practices with no interventions from the study

Who Is Running the Clinical Trial?

Brock University

Lead Sponsor

Trials

41

Recruited

6,500+

Novo Nordisk A/S

Industry Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Delivery Associates

Collaborator

Trials

1

Recruited

12,000+

Ophea

Collaborator

8 80 Cities

Collaborator

The Behavioural Insights Team

Collaborator

Trials

11

Recruited

2,055,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12285027/

Effectiveness of different intervention designs for improving ... Primary outcomes: steps per day, moderate-vigorous physical activity (MVPA) and combined physical activity. Secondary outcomes: sedentary time, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07191925

An Evaluation of "Growing Healthy Places: Mississauga" The goal of this intervention study is to learn if community co-designed activities to improve diet and physical activity can impact the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0033350625003750

The effectiveness of co-created lifestyle interventions in ... The findings showed that within a short timeframe (<6 months), co-created lifestyle interventions aimed at modifying lifestyle risk factors have a significant ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-018-6210-2

Implementation of a co-designed physical activity program for ... A partner-based health promotion intervention can be effectively implemented across settings to enhance PA, mobility and social connectedness in older adults.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8540362/

Co-Design Practices in Diet and Nutrition Research The primary objective of this review was to identify and describe co-design techniques used in nutrition research.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07191925

An Evaluation of "Growing Healthy Places: Mississauga" The goal of this intervention study is to learn if community co-designed activities to improve diet and physical activity can impact the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0031940625003554

Co-design of a personalised physical activity intervention ... The developed physical activity intervention included a shared decision-making process, programme set-up, ongoing support and resources. High levels of trust, ...

8. cdc.gov cdc.gov/physical-activity/php/strategies/increasing-physical-activity-through-community-design-prevention-strategies.html

Strategies for Physical Activity Through Community Design Activity-friendly communities include welcoming, safe, and convenient places to play, walk, roll and bike to enjoy destinations that the community has to offer.