SCORE! ACTIVE Trial

Hamilton Health Sciences (HHS)

Status: Enrolling

Conditions: Chronic Disease; Childhood Obesity

Treatments: Other: Health promotion; Other: Physical activity program; Other: Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06844786

17739

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 5 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 1 patient group

SCORE! ACTIVE

Experimental group

Description:

This is the only arm of the study. The interventions included in this arm are physical activity programming (SCORE! CLUB), navigator services (SCORE! navigator), and health promotion messaging. All clusters will receive this intervention.

Treatment:

Other: Navigation

Other: Physical activity program

Other: Health promotion