Pediatric ObesityCHErIsHNCT04108572
The Choosing Healthy Eating for Infant Health (CHErIsH) Study
A study testing Infant feeding in people with Pediatric Obesity, run by University College Cork at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Infant feeding
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 11 Apr 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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?
- Conditions
- Pediatric Obesity
- Being tested
- Infant feeding
- Keywords
- Child Obesity, Infant Feeding, Feasibility study
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant feedingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Infant feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Tp3= at infant's 13 month vaccination visit.
Secondary outcomes (5)
Intervention reach and recruitment
Number of invitations sent to parents, acceptances to participate, and refusals
Measured: 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
Number of missing items self report questionnaires and follow-up rates
Measured: 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
Checklist assessing intervention components received by parent (e.g., 'Did you receive a leaflet about infant feeding?').
Measured: Tp3= at infant's 13 month vaccination visit.
Healthcare professional intervention fidelity
Checklist assessing intervention components delivered by HCPs (e.g., 'Did you provide parent with a leaflet about infant feeding?').
Measured: Tp3= at infant's 13 month vaccination visit.
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.
Measured: Tp3= at infant's 13 month vaccination visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start11 Apr 2019
- Primary completion1 Jan 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland, University of Dublin, Trinity College
- Responsible party
- Principal investigator, Patricia Kearney, University College Cork
- Investigators
- Prof Patricia Kearney, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108572
- Sponsor's protocol ID
- HRB_CHErIsH
- Acronym
- CHErIsH
- Status last verified
- Oct 2021
- First submitted
- 24 May 2019
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28486211Black 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.
PubMed 28677302
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Choosing Healthy Eating for Infant Health (CHErIsH) Study
- ClinicalTrials.gov ID
- NCT04108572
- Acronym / sponsor ID
- CHErIsH / HRB_CHErIsH
- Conditions
- Pediatric Obesity
- Keywords
- Child Obesity, Infant Feeding, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland, University of Dublin, Trinity College
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomised feasibility study of an infant feeding intervention and implementation strategy, with embedded process evaluation and economic evaluation
| Arm | Type | Receives |
|---|---|---|
| Infant feeding intervention | Experimental | Behavioral: Infant feedingThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant feedingVerbally 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. | Behavioural | Infant feeding intervention |
Primary outcome
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.
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.
5 secondary outcomes
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.
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.
Parent intervention fidelity
Time frame: Tp3= at infant's 13 month vaccination visit.
Healthcare professional intervention fidelity
Time frame: Tp3= at infant's 13 month vaccination visit.
Estimate of resources and costs needed to deliver the intervention
Time frame: Tp3= at infant's 13 month vaccination visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 28486211Queally 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.
- Background: PubMed 28677302Black 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Patricia Kearney principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant feeding in people with Pediatric Obesity, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent intervention feedback (time frame: Tp3= at infant's 13 month vaccination visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108572, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.