The Choosing Healthy Eating for Infant Health (CHErIsH) Study

University College Cork (UCC)

Status: Completed

Conditions: Pediatric Obesity

Treatments: Behavioral: Infant feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT04108572

HRB_CHErIsH

Details and patient eligibility

About

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.

Full 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?

Enrollment: 50 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Infant feeding intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Infant feeding