Early Movers Pilot Intervention

NCT ID: NCT06538090

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-28

Study Completion Date

2025-07-30

Brief Summary

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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

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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.

Conditions

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Child Development Activity, Motor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Early Movers

Intervention Type BEHAVIORAL

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.

Control

Participant will receive standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Alberta Health services

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie Carson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Sam Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Victoria

Kylie Hesketh, PhD

Role: PRINCIPAL_INVESTIGATOR

Deakin University

Guy Faulkner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Lesley Pritchard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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Early Movers

Identifier Type: -

Identifier Source: org_study_id

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