Early Movers Pilot Intervention

Not Applicable

Recruiting

• Conditions: Child Development; Activity, Motor
• Interventions: Behavioral: Early Movers

• Registration Number: NCT06538090
• Lead Sponsor: University of Alberta

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-05
• Study Start: 2024-10-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-05-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Movers Intervention	Early Movers	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.

Primary Outcome Measures

Name	Time	Method
Parent acceptability (interviews)	4-month follow-up (Infant age: 6 months)	Brief semi-structured interviews with parents from the intervention group only
Parent acceptability (questionnaire)	4-month follow-up (Infant age: 6 months)	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
Feasibility (recruitment)	At recruitment completion, approximately 6 months from the start of 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.
Feasibility (retention)	At data collection completion, approximately 10 months from the start of recruitment	How many participants drop out
Feasibility (procedures; field observations)	Throughout the 6 months of recruitment	Field observations recorded by the research coordinator while at public health centres
Feasibility (procedures, interviews)	4-month follow-up (Infant age: 6 months)	Brief semi-structured interviews with parents from the intervention group only
Public health staff acceptability (interviews)	At recruitment completion, approximately 6 months from the start of recruitment	Brief semi-structured interviews with public health staff
Feasibility (data collection)	Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)	Completion rates of movement behaviour and development measures assessed in the questionnaire
Parent acceptability (app usage)	Between baseline (Infant age: 2 months) and 4-month follow-up (Infant age: 6 months)	App usage will be tracked in the intervention group only

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada