The Choosing Healthy Eating for Infant Health (CHErIsH) Study

NCT04108572 | Completed

• 1 other identifier: HRB_CHErIsH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Child Obesity; Infant Feeding; Feasibility study

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Tp3= at infant's 13 month vaccination visit.

Secondary Outcomes (5)

• 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.

• 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.

• Parent intervention fidelity

  Tp3= at infant's 13 month vaccination visit.

• Healthcare professional intervention fidelity

  Tp3= at infant's 13 month vaccination visit.

• Estimate of resources and costs needed to deliver the intervention

  Tp3= at infant's 13 month vaccination visit.

Study Arms (1)

Infant feeding intervention

EXPERIMENTAL

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

Interventions

Infant feeding BEHAVIORAL

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.

Infant feeding intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Involved in the delivery of routine infant vaccinations
• Completed training to deliver the intervention.
• 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.

You may not qualify if:

• n/a

Sponsors & Collaborators

• University College Cork: lead
• National University of Ireland, Galway, Ireland: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

Mallow Primary Health Care Centre

Cork, T12 VFP4, Ireland

Location

Related Publications (2)

• 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.

  PMID: 28486211 BACKGROUND

• 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.

  PMID: 28677302 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof Patricia Kearney

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Non-randomised feasibility study of an infant feeding intervention and implementation strategy, with embedded process evaluation and economic evaluation

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: September 30, 2019
• Study Start: April 11, 2019
• Primary Completion: January 1, 2020
• Study Completion: December 31, 2020
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)