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CompletedNCT06538090Updated Aug 1, 2025

Early Movers Pilot Intervention

An interventional study of Early Movers in Child Development and Activity, Motor, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 2 Months to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by University of Alberta · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
2 Months to 2 Months
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Child Development
  • Activity, Motor

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Keywords

  • Questionnaires
  • Semi-structured Interviews
03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 2 Months
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    Participant will receive standard care.

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At recruitment completion, approximately 6 months from the start of recruitment

  2. Feasibility (retention)

    How many participants drop out

    Time frame: At data collection completion, approximately 10 months from the start of recruitment

  3. Feasibility (procedures; field observations)

    Field observations recorded by the research coordinator while at public health centres

    Time frame: Throughout the 6 months of recruitment

  4. Feasibility (procedures, interviews)

    Brief semi-structured interviews with public health staff

    Time frame: At recruitment completion, approximately 6 months from the start of recruitment

  5. Feasibility (procedures, interviews)

    Brief semi-structured interviews with parents from the intervention group only

    Time frame: 4-month follow-up (Infant age: 6 months)

  6. Feasibility (data collection)

    Completion rates of movement behaviour and development measures assessed in the questionnaire

    Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

  7. Parent acceptability (interviews)

    Brief semi-structured interviews with parents from the intervention group only

    Time frame: 4-month follow-up (Infant age: 6 months)

  8. 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

    Time frame: 4-month follow-up (Infant age: 6 months)

  9. Parent acceptability (app usage)

    App usage will be tracked in the intervention group only

    Time frame: Between baseline (Infant age: 2 months) and 4-month follow-up (Infant age: 6 months)

  10. Public health staff acceptability (interviews)

    Brief semi-structured interviews with public health staff

    Time frame: At recruitment completion, approximately 6 months from the start of recruitment

Secondary outcomes

  1. Physical activity

    Tummy time measured in a parental questionnaire

    Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

  2. Sedentary behaviour

    Screen time, back time, reading time, restrained time in a stroller, car seat, etc. measured in a parental questionnaire

    Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

  3. Sleep

    Sleep measured in a parental questionnaire

    Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

  4. Development

    Development will be measured with the Ages and Stages Questionnaire (ASQ-3)

    Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

07

Study locations

1 site
  • University of Alberta
    Edmonton, Alberta T6G 2R3, Canada
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06538090
Lead sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR), Alberta Health services
Responsible party
Sponsor
First posted
Aug 5, 2024
Start date
Oct 28, 2024
Primary completion
Jul 30, 2025
Completion
Jul 30, 2025
Last update
Aug 1, 2025

Study contacts

Valerie Carson, PhD
principal investigator · University of Alberta
Sam Liu, PhD
principal investigator · University of Victoria
Kylie Hesketh, PhD
principal investigator · Deakin University
Guy Faulkner, PhD
principal investigator · University of British Columbia
Lesley Pritchard, PhD
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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