SCORE! ACTIVE Trial (ACTIVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease; Childhood Obesity
• Intervention / Treatment: Other: Physical activity program; Other: Navigation; Other: Health promotion

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 Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • Recruiting
      • McMaster University
      • Principal Investigator: Gita Wahi, MD
      • Contact: Patricia Montague, MSc.; Phone Number: 21523 905-525-9140; Email: pmontag@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SCORE! ACTIVE; 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.

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 Names: SCORE! Club; 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 Names: SCORE! Navigator; 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.; Other Names: Health promotion messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale	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.	Baseline to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Public Health Agency of Canada (PHAC)

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Disease Attributes; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity; Chronic Disease
• Other Study ID Numbers: 17739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No