Early Movers Pilot Intervention

NCT06538090 | Completed

• 1 other identifier: Early Movers
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development; Activity, Motor

Keywords

Questionnaires; Semi-structured Interviews

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• Physical activity

  Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

• Sedentary behaviour

  Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

• Sleep

  Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

• Development

  Baseline (Infant age: 2 months), 2-month follow-up (Infant age: 4 months), 4-month follow (Infant age: 6 months)

Study Arms (2)

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.

Behavioral: Early Movers

Control

NO INTERVENTION

Participant will receive standard care.

Interventions

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.

Early Movers Intervention

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• First time parents of infants who are aged 2 months 0 days through 2 months 30 days at baseline.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Health services: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Valerie Carson, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Sam Liu, PhD

  University of Victoria

  PRINCIPAL INVESTIGATOR

• Kylie Hesketh, PhD

  Deakin University

  PRINCIPAL INVESTIGATOR

• Guy Faulkner, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Lesley Pritchard, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: October 28, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)