Clinical trial NCT06844786: SCORE! ACTIVE Trial
Official title: SCORE! ACTIVE: Advancing Codesigned Health Promotion and Physical Activity Interventions to Improve Self-Efficacy and Health: A Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Childhood Obesity
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2025-02-25
Enrollment: 1400
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Newcomer families (those who have been in Canada for 10 years or less) with at least 1 child aged 5 up to 11 (11.99 years) living in a Hamilton, Ontario.
* At least one parent/guardian born outside of Canada and residing in Canada ≤ 10 years.
* Families must be living in one of the designated neighbourhood clusters

Exclusion Criteria:

* Children participating in organized physical activity programs for 3 or more times per week
* Families with involvement with child protection services and/or foster care

Primary outcomes:
measure: Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale
timeFrame: 12 months from baseline; 18 months from baseline
measure: Physical Activity & Sedentary Behavior Questionnaire
timeFrame: Baseline to 18 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: