An interventional study of Infant feeding in Pediatric Obesity, sponsored by University College Cork. Completed at 1 site in Ireland. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by University College Cork · Not applicable, Interventional, and Prevention
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.
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:
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 50 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Health care professionals):
Inclusion Criteria (Parents):
Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: Tp3= at infant's 13 month vaccination visit.
Intervention reach and recruitment
Number of invitations sent to parents, acceptances to participate, and refusals
Time frame: 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
Time frame: 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?').
Time frame: 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?').
Time frame: 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.
Time frame: Tp3= at infant's 13 month vaccination visit.
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University College Cork