SCORE! ACTIVE Trial

Not Applicable

Recruiting

• Conditions: Chronic Disease; Childhood Obesity

• Registration Number: NCT06844786
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Study Start: 2025-03-01
• Primary Completion: 2027-08-15
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale	Baseline to 6 months	Using CSAPPA, a 19-item scale that measures how children feel about their physical activity skills and their likelihood of choosing physical activities, a change in children's physical activity self-efficacy will be measured at 6 months as the primary outcome.

Secondary Outcome Measures

Name	Time	Method
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale	12 months from baseline; 18 months from baseline	Using CSAPPA, a change in children's physical activity self-efficacy will also be measured at 12 and 18 months as secondary outcomes.
Physical Activity & Sedentary Behavior Questionnaire	Baseline to 18 months	Changes in children's physical activity and sedentary behaviours will be measured using the Physical Activity \& Sedentary Behavior Questionnaire.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada