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Completed

NCT Number: NCT06538090

Early Movers Pilot Intervention

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.

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Key information

Age range

2 month–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Movers

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.

Primary outcomes

  1. 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.

  2. Feasibility (retention)

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

    How many participants drop out

  3. Feasibility (procedures; field observations)

    Time frame: Throughout the 6 months of recruitment

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

  4. Feasibility (procedures, interviews)

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

    Brief semi-structured interviews with public health staff

  5. Feasibility (procedures, interviews)

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

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

  6. 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

  7. Parent acceptability (interviews)

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

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

  8. 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

  9. 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

  10. 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

Secondary outcomes

  1. Physical activity

    Time frame: 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

  2. Sedentary behaviour

    Time frame: 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

  3. Sleep

    Time frame: 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

  4. Development

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Health services
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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