The Choosing Healthy Eating for Infant Health (CHErIsH) Study (CHErIsH)
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Infant feeding
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Obesity focused on measuring Child Obesity, Infant Feeding, Feasibility study
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
Sites / Locations
- Mallow Primary Health Care Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infant feeding intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Intervention reach and recruitment
Number of invitations sent to parents, acceptances to participate, and refusals
Appropriateness of parent data collection processes and outcome measures
Number of missing items self report questionnaires and follow-up rates
Parent intervention fidelity
Checklist assessing intervention components received by parent (e.g., 'Did you receive a leaflet about infant feeding?').
Healthcare professional intervention fidelity
Checklist assessing intervention components delivered by HCPs (e.g., 'Did you provide parent with a leaflet about infant feeding?').
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.
Full Information
NCT ID
NCT04108572
First Posted
May 24, 2019
Last Updated
October 4, 2021
Sponsor
University College Cork
Collaborators
National University of Ireland, Galway, Ireland, University of Dublin, Trinity College
1. Study Identification
Unique Protocol Identification Number
NCT04108572
Brief Title
The Choosing Healthy Eating for Infant Health (CHErIsH) Study
Acronym
CHErIsH
Official Title
The Choosing Healthy Eating for Infant Health (CHErIsH) Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork
Collaborators
National University of Ireland, Galway, Ireland, University of Dublin, Trinity College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Are the intervention content, delivery and implementation procedures acceptable to parents who will receive the intervention, and HCPs who will deliver the intervention?
Are the data collection processes, including mode and duration of data collection and outcome measures used, acceptable to parents and HCPs?
Is the intervention feasible to deliver in primary care practice, in terms fidelity of delivery and receipt of the intervention?
Is the study feasible in terms of recruitment and retention procedures and data collection?
What are the costs associated with the intervention and its implementation strategy?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Child Obesity, Infant Feeding, Feasibility study
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomised feasibility study of an infant feeding intervention and implementation strategy, with embedded process evaluation and economic evaluation
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infant feeding intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Infant feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parent intervention feedback
Description
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.
Title
Healthcare professional intervention feedback
Description
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.
Secondary Outcome Measure Information:
Title
Intervention reach and recruitment
Description
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.
Title
Appropriateness of parent data collection processes and outcome measures
Description
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.
Title
Parent intervention fidelity
Description
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.
Title
Healthcare professional intervention fidelity
Description
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.
Title
Estimate of resources and costs needed to deliver the intervention
Description
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Patricia Kearney
Organizational Affiliation
University College Cork
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mallow Primary Health Care Centre
City
Cork
ZIP/Postal Code
T12 VFP4
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28486211
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.
Results Reference
background
PubMed Identifier
28677302
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.
Results Reference
background
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The Choosing Healthy Eating for Infant Health (CHErIsH) Study
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