The Choosing Healthy Eating for Infant Health (CHErIsH) Study

Pediatric Obesity Clinical Trial

— CHErIsH  

Official title:

The Choosing Healthy Eating for Infant Health (CHErIsH) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108572
• Other study ID #: HRB_CHErIsH
• Status: Completed
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Ireland	Mallow Primary Health Care Centre	Cork

Sponsors (3)

Lead Sponsor	Collaborator
University College Cork	National University of Ireland, Galway, Ireland, University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Intervention reach and recruitment	Number of invitations sent to parents, acceptances to participate, and refusals	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.
Secondary	Appropriateness of parent data collection processes and outcome measures	Number of missing items self report questionnaires and follow-up rates	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.
Secondary	Parent intervention fidelity	Checklist assessing intervention components received by parent (e.g., 'Did you receive a leaflet about infant feeding?').	Tp3= at infant's 13 month vaccination visit.
Secondary	Healthcare professional intervention fidelity	Checklist assessing intervention components delivered by HCPs (e.g., 'Did you provide parent with a leaflet about infant feeding?').	Tp3= at infant's 13 month vaccination visit.
Secondary	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.	Tp3= at infant's 13 month vaccination visit.