Early Movers Pilot Intervention

The Early Movers Pilot Intervention: Encouraging Healthy Movement Behaviours in Infants

Our Early Movers longitudinal study found that adherence to the Canadian 24-Hour Movement Guidelines in infancy is low across demographic groups, impacting overall development. Early Movers is a parent-focused intervention designed to increase dissemination and activation of the 24-Hour Movement Behaviour Guidelines for the Early Years. It adapts an established Australian intervention called INFANT. An important first step is conducting a pilot study.

Study Overview

• Status: Completed
• Conditions: Child Development; Activity, Motor
• Intervention / Treatment: Behavioral: Early Movers

Detailed Description

Our goal is to examine the feasibility and acceptability of the Early Movers intervention, a scalable, theory-based, parent-focused intervention designed to increase dissemination and activation of the 24-Hour Movement Behaviour Guidelines for the Early Years.

Primary Objectives:

1. Explore the feasibility of the Early Movers intervention protocol, including recruitment, retention, data collection, and procedures. Specifically, we will examine:

   1. the willingness of first-time parents to enroll and remain in the study,
   2. data collection completion rates, and
   3. the integrity of the protocol components to all work together and run smoothly.
2. Explore the acceptability of the intervention by parents and public health staff.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • University of Alberta

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

-First time parents of infants who are aged 2 months 0 days through 2 months 30 days at baseline.

Exclusion Criteria:

• Parents who do not confidently speak or read English
• Infants who are regularly cared for by an adult other then their parent/guardian for a number of hours per week (e.g. full time child care)
• Infants born preterm (gestational age <37 weeks)
• Infants born underweight (<2500 g)
• Infants with a medical condition or health complication since birth that could impact their movement behaviours and/or development

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Movers Intervention; Participants will receive an educational resource (i.e., hard copy hand-out), access to a digital app with an online toolkit and weekly text messages that includes tips and supportive messaging.	Behavioral: Early Movers; The intervention includes: 1) an educational resource (i.e., hard-copy handout) developed for this study on the 24-Hour Movement Guidelines provided to parents at 2-month immunization appointments by public health nurses, who will answer any questions, followed by a discussion with research staff. 2) Follow-up support via access to a digital app with evidence-based information and support through an online toolkit, an anonymous forum, as well as weekly text messages that include tips and supportive messaging related to the guidelines.
No Intervention: Control; Participant will receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (recruitment)	How many appointments the research coordinator attends, how many families the research coordinator speaks to, how many families are eligible, and how many families enroll in the trial.	At recruitment completion, approximately 6 months from the start of recruitment
Feasibility (retention)	How many participants drop out	At data collection completion, approximately 10 months from the start of recruitment
Feasibility (procedures; field observations)	Field observations recorded by the research coordinator while at public health centres	Throughout the 6 months of recruitment
Feasibility (procedures, interviews)	Brief semi-structured interviews with public health staff	At recruitment completion, approximately 6 months from the start of recruitment
Feasibility (procedures, interviews)	Brief semi-structured interviews with parents from the intervention group only	4-month follow-up (Infant age: 6 months)
Feasibility (data collection)	Completion rates of movement behaviour and development measures assessed in the questionnaire	Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Parent acceptability (interviews)	Brief semi-structured interviews with parents from the intervention group only	4-month follow-up (Infant age: 6 months)
Parent acceptability (questionnaire)	Intervention usefulness, satisfaction (content and delivery), and novelty assessed via a parental questionnaire in the intervention group only. This scale includes 4 items with values of 1-5; higher values mean more acceptability	4-month follow-up (Infant age: 6 months)
Parent acceptability (app usage)	App usage will be tracked in the intervention group only	Between baseline (Infant age: 2 months) and 4-month follow-up (Infant age: 6 months)
Public health staff acceptability (interviews)	Brief semi-structured interviews with public health staff	At recruitment completion, approximately 6 months from the start of recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Tummy time measured in a parental questionnaire	Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Sedentary behaviour	Screen time, back time, reading time, restrained time in a stroller, car seat, etc. measured in a parental questionnaire	Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Sleep	Sleep measured in a parental questionnaire	Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Development	Development will be measured with the Ages and Stages Questionnaire (ASQ-3)	Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian Institutes of Health Research (CIHR); Alberta Health services
• Investigators: Principal Investigator: Guy Faulkner, PhD, University of British Columbia; Principal Investigator: Lesley Pritchard, PhD, University of Alberta; Principal Investigator: Valerie Carson, PhD, University of Alberta; Principal Investigator: Sam Liu, PhD, University of Victoria; Principal Investigator: Kylie Hesketh, PhD, Deakin University

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Questionnaires; Semi-structured Interviews
• Other Study ID Numbers: Early Movers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to ethical reasons, individual participant data (IPD) will not be publicly available. De-identified data may be available to other researchers upon reasonable request.

Drug and device information, study documents

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