Child DevelopmentNCT06538090
Early Movers Pilot Intervention
A study testing Early Movers in people with Child Development and Activity, Motor, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Activity, Motor
- What is being tested?
- Early Movers
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 28 Oct 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -First time parents of infants who are aged 2 months 0 days through 2 months 30 days at baseline.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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:
- Explore the feasibility of the Early Movers intervention protocol, including recruitment, retention, data collection, and procedures. Specifically, we will examine:
- the willingness of first-time parents to enroll and remain in the study,
- data collection completion rates, and
- the integrity of the protocol components to all work together and run smoothly.
- Explore the acceptability of the intervention by parents and public health staff.
- Conditions
- Child Development, Activity, Motor
- Being tested
- Early Movers
- Keywords
- Questionnaires, Semi-structured Interviews
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early MoversBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Movers Intervention | Experimental | 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. Receives: Behavioral: Early Movers |
| Control | No intervention | Participant will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At recruitment completion, approximately 6 months from the start of recruitment
Feasibility (retention)
How many participants drop out
Measured: 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
Measured: Throughout the 6 months of recruitment
Feasibility (procedures, interviews)
Brief semi-structured interviews with public health staff
Measured: 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
Measured: 4-month follow-up (Infant age: 6 months)
Feasibility (data collection)
Completion rates of movement behaviour and development measures assessed in the questionnaire
Measured: 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
Measured: 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
Measured: 4-month follow-up (Infant age: 6 months)
Parent acceptability (app usage)
App usage will be tracked in the intervention group only
Measured: 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
Measured: At recruitment completion, approximately 6 months from the start of recruitment
Secondary outcomes (4)
Physical activity
Tummy time measured in a parental questionnaire
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start28 Oct 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will be randomly assigned to group 1 (intervention) or group 2 (control), in a computer generated 1:1 sequence.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Valerie Carson, PhD, Principal investigator, University of AlbertaSam Liu, PhD, Principal investigator, University of VictoriaKylie Hesketh, PhD, Principal investigator, Deakin UniversityGuy Faulkner, PhD, Principal investigator, University of British ColumbiaLesley Pritchard, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538090
- Sponsor's protocol ID
- Early Movers
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Movers Pilot Intervention: Encouraging Healthy Movement Behaviours in Infants
- ClinicalTrials.gov ID
- NCT06538090
- Acronym / sponsor ID
- Early Movers
- Conditions
- Child Development, Activity, Motor
- Keywords
- Questionnaires, Semi-structured Interviews
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Health services
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Explore the feasibility of the Early Movers intervention protocol, including recruitment, retention, data collection, and procedures. Specifically, we will examine:
- the willingness of first-time parents to enroll and remain in the study,
- data collection completion rates, and
- the integrity of the protocol components to all work together and run smoothly.
- Explore the acceptability of the intervention by parents and public health staff.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will be randomly assigned to group 1 (intervention) or group 2 (control), in a computer generated 1:1 sequence.
| Arm | Type | Receives |
|---|---|---|
| Early Movers Intervention | Experimental | Behavioral: Early MoversParticipants 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. |
| Control | No intervention | –Participant will receive standard care. |
Who may qualify
- Ages
- 2 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -First time parents of infants who are aged 2 months 0 days through 2 months 30 days at baseline.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early MoversThe 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. | Behavioural | Early Movers Intervention |
Primary outcome
Feasibility (recruitment)
Time frame: 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)
Time frame: At data collection completion, approximately 10 months from the start of recruitment
How many participants drop out
Feasibility (procedures; field observations)
Time frame: Throughout the 6 months of recruitment
Field observations recorded by the research coordinator while at public health centres
Feasibility (procedures, interviews)
Time frame: At recruitment completion, approximately 6 months from the start of recruitment
Brief semi-structured interviews with public health staff
Feasibility (procedures, interviews)
Time frame: 4-month follow-up (Infant age: 6 months)
Brief semi-structured interviews with parents from the intervention group only
Feasibility (data collection)
Time frame: 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)
Time frame: 4-month follow-up (Infant age: 6 months)
Brief semi-structured interviews with parents from the intervention group only
Parent acceptability (questionnaire)
Time frame: 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)
Time frame: 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
Public health staff acceptability (interviews)
Time frame: At recruitment completion, approximately 6 months from the start of recruitment
Brief semi-structured interviews with public health staff
4 secondary outcomes
Physical activity
Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Sedentary behaviour
Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Sleep
Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Development
Time frame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Carson, PhD principal investigator
University of Alberta
Sam Liu, PhD principal investigator
University of Victoria
Kylie Hesketh, PhD principal investigator
Deakin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Movers in people with Child Development and Activity, Motor, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (recruitment) (time frame: At recruitment completion, approximately 6 months from the start of recruitment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.