Early Movers Pilot Intervention
NCT Number: NCT06538090
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Development|Activity, Motor
Interventions: BEHAVIORAL: Early Movers
Sponsor: University of Alberta
Collaborators: Canadian Institutes of Health Research (CIHR)|Alberta Health services
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-09-30

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.

Primary Outcome Measures: 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., At recruitment completion, approximately 6 months from the start of recruitment|Feasibility (retention), How many participants drop out, 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, Throughout the 6 months of recruitment|Feasibility (procedures, interviews), Brief semi-structured interviews with public health staff, 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, 4-month follow-up (Infant age: 6 months)|Feasibility (data collection), Completion rates of movement behaviour and development measures assessed in the questionnaire, 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, 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, 4-month follow-up (Infant age: 6 months)|Parent acceptability (app usage), App usage will be tracked in the intervention group only, 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, At recruitment completion, approximately 6 months from the start of recruitment
Secondary Outcome Measures: Physical activity, Tummy time measured in a parental questionnaire, 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, 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, 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), Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)