Clinical trial NCT06538090: Early Movers Pilot Intervention
Official title: The Early Movers Pilot Intervention: Encouraging Healthy Movement Behaviours in Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Activity, Motor
Keywords: Questionnaires
Semi-structured Interviews
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Alberta Health services
First posted: 2024-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will be randomly assigned to group 1 (intervention) or group 2 (control), in a computer generated 1:1 sequence.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility (recruitment)
timeFrame: At recruitment completion, approximately 6 months from the start of recruitment
measure: Feasibility (retention)
timeFrame: At data collection completion, approximately 10 months from the start of recruitment
measure: Feasibility (procedures; field observations)
timeFrame: Throughout the 6 months of recruitment
measure: Feasibility (procedures, interviews)
timeFrame: At recruitment completion, approximately 6 months from the start of recruitment
measure: Feasibility (procedures, interviews)
timeFrame: 4-month follow-up (Infant age: 6 months)
measure: Feasibility (data collection)
timeFrame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
measure: Parent acceptability (interviews)
timeFrame: 4-month follow-up (Infant age: 6 months)
measure: Parent acceptability (questionnaire)
timeFrame: 4-month follow-up (Infant age: 6 months)
measure: Parent acceptability (app usage)
timeFrame: Between baseline (Infant age: 2 months) and 4-month follow-up (Infant age: 6 months)
measure: Public health staff acceptability (interviews)
timeFrame: At recruitment completion, approximately 6 months from the start of recruitment
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
measure: Sedentary behaviour
timeFrame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
measure: Sleep
timeFrame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
measure: Development
timeFrame: Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Valerie Carson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Victoria
name: Sam Liu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deakin University
name: Kylie Hesketh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Guy Faulkner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Lesley Pritchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: