The Early Movers Pilot Intervention: Encouraging Healthy Movement Behaviours in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Parent acceptability (interviews)
研究概览
简要总结
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.
详细描述
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:
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Explore the feasibility of the Early Movers intervention protocol, including recruitment, retention, data collection, and procedures. Specifically, we will examine:
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the willingness of first-time parents to enroll and remain in the study,
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data collection completion rates, and
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the integrity of the protocol components to all work together and run smoothly.
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Explore the acceptability of the intervention by parents and public health staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 2 Months 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First time parents of infants who are aged 2 months 0 days through 2 months 30 days at baseline.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Early Movers (Behavioral)
Control
Participant will receive standard care.
结局指标
主要结局
Parent acceptability (interviews)
时间窗: 4-month follow-up (Infant age: 6 months)
Brief semi-structured interviews with parents from the intervention group only
Parent acceptability (questionnaire)
时间窗: 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
Feasibility (recruitment)
时间窗: 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.
Feasibility (retention)
时间窗: At data collection completion, approximately 10 months from the start of recruitment
How many participants drop out
Feasibility (data collection)
时间窗: 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
Parent acceptability (app usage)
时间窗: 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
Feasibility (procedures; field observations)
时间窗: Throughout the 6 months of recruitment
Field observations recorded by the research coordinator while at public health centres
Feasibility (procedures, interviews)
时间窗: 4-month follow-up (Infant age: 6 months)
Brief semi-structured interviews with parents from the intervention group only
Public health staff acceptability (interviews)
时间窗: At recruitment completion, approximately 6 months from the start of recruitment
Brief semi-structured interviews with public health staff
Feasibility (procedures, interviews)
时间窗: At recruitment completion, approximately 6 months from the start of recruitment
Brief semi-structured interviews with public health staff
次要结局
- 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))
- Physical activity(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))