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Early Movers Pilot Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06538090
Enrollment
60
Registered
2024-08-05
Start date
2024-10-28
Completion date
2025-07-30
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activity, Motor, Child Development

Keywords

Questionnaires, Semi-structured Interviews

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.

Interventions

BEHAVIORALEarly 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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Alberta Health services
CollaboratorOTHER
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants: While the families will not be told explicitly if they have been assigned to the intervention or control group, they may be able to determine their group based on the information regarding movement behaviours they receive/do not receive during their 2 month immunization appointment. Research Coordinator: The research coordinator will be aware of the group allocations as they will be in charge of coordinating random assignment and have to schedule other measures based on their specific allocation.

Intervention model description

All participants will be randomly assigned to group 1 (intervention) or group 2 (control), in a computer generated 1:1 sequence.

Eligibility

Sex/Gender
ALL
Age
2 Months to 2 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Public health staff acceptability (interviews)At recruitment completion, approximately 6 months from the start of recruitmentBrief 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 (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
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
Feasibility (recruitment)At recruitment completion, approximately 6 months from the start of recruitmentHow 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 recruitmentHow many participants drop out
Feasibility (procedures; field observations)Throughout the 6 months of recruitmentField observations recorded by the research coordinator while at public health centres
Feasibility (procedures, interviews)At recruitment completion, approximately 6 months from the start of recruitmentBrief semi-structured interviews with public health staff

Secondary

MeasureTime frameDescription
Sedentary behaviourBaseline (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
SleepBaseline (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
DevelopmentBaseline (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)
Physical activityBaseline (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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026