The Choosing Healthy Eating for Infant Health (CHErIsH) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Healthcare professional intervention feedback
研究概览
简要总结
The Choosing Healthy Eating for Infant Health (CHErIsH) intervention is a complex infant feeding intervention delivered at infant vaccination visits, alongside a healthcare professional (HCP) level implementation strategy to support delivery. The primary aim of CHErIsH pilot feasibility study is to collect and examine data on the acceptability and feasibility of the delivery of the brief infant-feeding intervention by HCPs to parents at child vaccination visits, and the strategy to support the implementation of this intervention in primary care for HCPs. Furthermore, half of all potential participants will be invited to provide maternal and infant biomarkers and/or take part in SWAT (study within a trial) which includes questions about infant feeding that were put together as part of a Core Outcome Set. These questions are important as they give a better understanding about what works and what doesn't. This will facilitate the refinement of the intervention and its implementation strategy, and inform the next step of the CHErIsH study, such as a definitive trial.
详细描述
The Choosing Healthy Eating for Infant Health (CHErIsH) intervention is a non-randomised feasibility study of an infant feeding intervention and implementation strategy, with embedded process evaluation and economic evaluation.
The CHErIsH feasibility study will address the following research questions:
- Are the intervention content, delivery and implementation procedures acceptable to parents who will receive the intervention, and HCPs who will deliver the intervention?
- Are the data collection processes, including mode and duration of data collection and outcome measures used, acceptable to parents and HCPs?
- Is the intervention feasible to deliver in primary care practice, in terms fidelity of delivery and receipt of the intervention?
- Is the study feasible in terms of recruitment and retention procedures and data collection?
- What are the costs associated with the intervention and its implementation strategy?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Healthcare professional intervention feedback
时间窗: Tp3= at infant's 13 month vaccination visit.
Four-item measures of implementation outcomes including Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM) will be used together to assess the acceptability, appropriateness and feasibility of the parent-level intervention (following intervention cessation). Scale values range from 1 to 5. 1 = completely disagree and 5 completely agree.
Parent intervention feedback
时间窗: Tp3= at infant's 13 month vaccination visit.
Four-item measures of implementation outcomes including Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM) will be used together to assess the acceptability, appropriateness and feasibility of the parent-level intervention (following intervention cessation). Scale values range from 1 to 5. 1 = completely disagree and 5 completely agree.
次要结局
- Appropriateness of parent data collection processes and outcome measures(Tp1= baseline, prior to infant's 2-month vaccination visit; Tp2= by the infant's 6-month vaccination visit); Tp3= at infant's 13 month vaccination visit.)
- Estimate of resources and costs needed to deliver the intervention(Tp3= at infant's 13 month vaccination visit.)
- Intervention reach and recruitment(Tp1= baseline, prior to infant's 2-month vaccination visit; Tp2= by the infant's 6-month vaccination visit); Tp3= at infant's 13 month vaccination visit.)
- Parent intervention fidelity(Tp3= at infant's 13 month vaccination visit.)
- Healthcare professional intervention fidelity(Tp3= at infant's 13 month vaccination visit.)
研究者
Patricia Kearney
Principle Investigator
University College Cork