The Choosing Healthy Eating for Infant Health (CHErIsH) Study

Not Applicable

Completed

• Conditions: Pediatric Obesity
• Interventions: Behavioral: Infant feeding

• Registration Number: NCT04108572
• Lead Sponsor: University College Cork

Brief Summary

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

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:

1. Are the intervention content, delivery and implementation procedures acceptable to parents who will receive the intervention, and HCPs who will deliver the intervention?

2. Are the data collection processes, including mode and duration of data collection and outcome measures used, acceptable to parents and HCPs?

3. Is the intervention feasible to deliver in primary care practice, in terms fidelity of delivery and receipt of the intervention?

4. Is the study feasible in terms of recruitment and retention procedures and data collection?

5. What are the costs associated with the intervention and its implementation strategy?

Study Timeline

• Study Start: 2019-04-11
• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-30
• Primary Completion: 2020-01-01
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• n/a

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infant feeding intervention	Infant feeding	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.

Primary Outcome Measures

Name	Time	Method
Healthcare professional intervention feedback	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	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.

Secondary Outcome Measures

Name	Time	Method
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.	Number of missing items self report questionnaires and follow-up rates
Estimate of resources and costs needed to deliver the intervention	Tp3= at infant's 13 month vaccination visit.	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.
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.	Number of invitations sent to parents, acceptances to participate, and refusals
Parent intervention fidelity	Tp3= at infant's 13 month vaccination visit.	Checklist assessing intervention components received by parent (e.g., 'Did you receive a leaflet about infant feeding?').
Healthcare professional intervention fidelity	Tp3= at infant's 13 month vaccination visit.	Checklist assessing intervention components delivered by HCPs (e.g., 'Did you provide parent with a leaflet about infant feeding?').

Trial Locations

Locations (1)

Mallow Primary Health Care Centre; 🇮🇪 Cork, Ireland