Clinical trial NCT04108572: The Choosing Healthy Eating for Infant Health (CHErIsH) Study
Official title: The Choosing Healthy Eating for Infant Health (CHErIsH) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Child Obesity
Infant Feeding
Feasibility study
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: National University of Ireland, Galway, Ireland
name: University of Dublin, Trinity College
First posted: 2019-09-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomised feasibility study of an infant feeding intervention and implementation strategy, with embedded process evaluation and economic evaluation
Primary purpose: PREVENTION

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?

Eligibility 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

Primary outcomes:
measure: Parent intervention feedback
timeFrame: Tp3= at infant's 13 month vaccination visit.
measure: Healthcare professional intervention feedback
timeFrame: Tp3= at infant's 13 month vaccination visit.
Secondary outcomes:
measure: Intervention reach and recruitment
timeFrame: 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.
measure: Appropriateness of parent data collection processes and outcome measures
timeFrame: 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.
measure: Parent intervention fidelity
timeFrame: Tp3= at infant's 13 month vaccination visit.
measure: Healthcare professional intervention fidelity
timeFrame: Tp3= at infant's 13 month vaccination visit.
measure: Estimate of resources and costs needed to deliver the intervention
timeFrame: Tp3= at infant's 13 month vaccination visit.
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Mallow Primary Health Care Centre
Study officials:
affiliation: University College Cork
name: Prof Patricia Kearney
role: PRINCIPAL_INVESTIGATOR
References:
citation: Queally M, Doherty E, Finucane FM, O'Neill C. Low expectations: Do teachers underestimate the ability of overweight children or the children of overweight mothers? Econ Hum Biol. 2017 Nov;27(Pt A):26-32. doi: 10.1016/j.ehb.2017.04.006. Epub 2017 Apr 28.
citation: Black L, Matvienko-Sikar K, Kearney PM. The association between childcare arrangements and risk of overweight and obesity in childhood: a systematic review. Obes Rev. 2017 Oct;18(10):1170-1190. doi: 10.1111/obr.12575. Epub 2017 Jul 4.