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Completed

NCT Number: NCT04108572

The Choosing Healthy Eating for Infant Health (CHErIsH) Study

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mallow Primary Health Care Centre

Cork, T12 VFP4, Ireland

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Parent intervention feedback

    Time frame: Tp3= at infant's 13 month vaccination visit.

    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.

  2. Healthcare professional intervention feedback

    Time frame: Tp3= at infant's 13 month vaccination visit.

    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 outcomes

  1. Intervention reach and recruitment

    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.

    Number of invitations sent to parents, acceptances to participate, and refusals

  2. Appropriateness of parent data collection processes and outcome measures

    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.

    Number of missing items self report questionnaires and follow-up rates

  3. Parent intervention fidelity

    Time frame: Tp3= at infant's 13 month vaccination visit.

    Checklist assessing intervention components received by parent (e.g., 'Did you receive a leaflet about infant feeding?').

  4. Healthcare professional intervention fidelity

    Time frame: Tp3= at infant's 13 month vaccination visit.

    Checklist assessing intervention components delivered by HCPs (e.g., 'Did you provide parent with a leaflet about infant feeding?').

  5. Estimate of resources and costs needed to deliver the intervention

    Time frame: Tp3= at infant's 13 month vaccination visit.

    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.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • National University of Ireland, Galway, Ireland
  • University of Dublin, Trinity College

Registry information

Acronym: CHErIsH

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2019
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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