Clinical Trials Directory

Trials / Completed

CompletedNCT04108572

The Choosing Healthy Eating for Infant Health (CHErIsH) Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
University College Cork · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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?

Conditions

Interventions

TypeNameDescription
BEHAVIORALInfant feedingVerbally 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.

Timeline

Start date
2019-04-11
Primary completion
2020-01-01
Completion
2020-12-31
First posted
2019-09-30
Last updated
2021-10-05

Locations

1 site across 1 country: Ireland

Source: ClinicalTrials.gov record NCT04108572. Inclusion in this directory is not an endorsement.