NCT06844786

SCORE! ACTIVE Trial

SCORE! ACTIVE: Advancing Codesigned Health Promotion and Physical Activity Interventions to Improve Self-Efficacy and Health: A Stepped Wedge Cluster Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Accepted

Summary

Hamilton is a city with a growing newcomer population. Families who are new to Canada do not always have the same resources to access healthy active living (HAL) activities as compared to Canadian-born families. The SCORE! ACTIVE trial will recruit newcomer families with young children in Hamilton and help provide them with access to HAL activities. Through this, the investigators want to see if newcomer children's perspectives of physical activity will change over time. They will also see if increasing newcomer children's access to these resources will promote an increase in HAL behaviours.

Detailed description

The investigators will conduct a pragmatic, stepped-wedge cluster randomized trial in 14 neighbourhoods to determine the impact of SCORE! ACTIVE trial on the primary outcome of PA self-efficacy among 5-11-year-old children. The SW-CRT involves the sequential transition of clusters, in this case neighbourhoods, from control to intervention conditions in a randomized order. In this case, the method is pragmatic because recruitment and initial baseline measures in each community will occur just before the initiation of the intervention. There have been methodological challenges noted with SW-CRT including identification and recruitment bias, within cluster bias, and secular trends. However, this design is ideal for the implementation of the SCORE! ACTIVE trial because for practical reasons, it is not possible to deliver the intervention to many clusters at the same time. The trial will be reported using CONSORT guidelines and extension of SW-CRT.

Conditions

• Chronic Disease
• Childhood Obesity

Interventions

Type	Name	Description
OTHER	Physical activity program	SCORE! Club is offered twice a week for enrolled participants. Modules will include soccer, arts and health, Sportball, and nature-based activities.
OTHER	Navigation	Participants will have access to a navigator from the study team who will help them access resources relating to recreation and physical activity in their communities. For example, the navigator will help direct families with low income to the recreation assistance program if they are interested in such a service.
OTHER	Health promotion	Health promotion messaging will be provided to participants via social media and other physical methods (i.e., flyers). Topics will include diet, sleep, physical activity, and other related items.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-08-15
• Completion: 2028-08-31
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: Canada