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The Choosing Healthy Eating for Infant Health (CHErIsH) Study (CHErIsH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04108572
Recruitment Status : Enrolling by invitation
First Posted : September 30, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
National University of Ireland, Galway, Ireland
University of Dublin, Trinity College
Information provided by (Responsible Party):
Patricia Kearney, University College Cork

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Infant feeding Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: The Choosing Healthy Eating for Infant Health (CHErIsH) Study
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Infant feeding intervention
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
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 Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108572


Locations
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Ireland
Mallow Primary Health Care Centre
Cork, Ireland, T12 VFP4
Sponsors and Collaborators
University College Cork
National University of Ireland, Galway, Ireland
University of Dublin, Trinity College
Investigators
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Principal Investigator: Prof Patricia Kearney University College Cork

Publications:
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Responsible Party: Patricia Kearney, Principle Investigator, University College Cork
ClinicalTrials.gov Identifier: NCT04108572    
Other Study ID Numbers: HRB_CHErIsH
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Kearney, University College Cork:
Child Obesity
Infant Feeding
Feasibility study
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms