The Choosing Healthy Eating for Infant Health (CHErIsH) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

Official Title
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The Choosing Healthy Eating for Infant Health (CHErIsH) Study

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: Infant feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Health care professionals): Involved in the delivery of routine infant vaccinations Completed training to deliver the intervention. Inclusion Criteria (Parents): Parent of an infant ≤ 6 weeks of age at study recruitment. Intends to attend a participating GP and/or PN in the primary care centre for child's vaccination visits. Is over 18 years of age. Can provide written informed consent to participate. Exclusion Criteria: n/a
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Non-randomised feasibility study of an infant feeding intervention and implementation strategy, with embedded process evaluation and economic evaluation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant feeding intervention<br>The intervention will be delivered to parents by practice nurses and/or GPs in MPHC at each of the vaccination visits, prior to administration of the vaccination. These vaccination visits take place at 2, 4, 6, 12 and 13 months. This intervention consists of 1) verbally delivered pre-specified infant feeding messages, and 2) provision of additional infant-feeding resources including an information leaflet, a magnet, an infant bib and access to an informational website. | Behavioral: Infant feeding<br>* Verbally delivered pre-specified infant feeding message. The messages focus on appropriate milk feeding and establishing complementary feeding and solid food introduction in relation to timing and practical guidance around processes of feeding and provision of additional infant-feeding resources including information leaflet, a magnet, an infant bib and access to an informational website.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent intervention feedback | 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. | Tp3= at infant's 13 month vaccination visit. | 
| Healthcare professional intervention feedback | 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. | Tp3= at infant's 13 month vaccination visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention reach and recruitment | Number of invitations sent to parents, acceptances to participate, and refusals | 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. | 
| Appropriateness of parent data collection processes and outcome measures | Number of missing items self report questionnaires and follow-up rates | 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 | Checklist assessing intervention components received by parent (e.g., 'Did you receive a leaflet about infant feeding?'). | Tp3= at infant's 13 month vaccination visit. | 
| Healthcare professional intervention fidelity | Checklist assessing intervention components delivered by HCPs (e.g., 'Did you provide parent with a leaflet about infant feeding?'). | Tp3= at infant's 13 month vaccination visit. | 
| Estimate of resources and costs needed to deliver the intervention | Resources in relation the intervention will be identified. Costs incurred as a consequence of the intervention and implementation strategy will be identified. This will include all time and resources expended, and costs borne by Healthcare Centre including the training and time spent by healthcare professionals and administrative staff involved in the study. | Tp3= at infant's 13 month vaccination visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child Obesity, Infant Feeding, Feasibility study