Measurement properties of outcome measurement instruments used to measure caregiver feeding practices and feeding environment, infant diet, and infant anthropometry outcomes: Protocol for a systematic review

Karen Matvienko-Sikar; Dimity Dutch; Moira Duffy; Eibhlín Looney; Victoria Brown; John Browne; Darren Dahly; Declan Devane; Janas Harrington; Brittany J. Johnson; Rebecca K. Golley; Marian McBride; Patricia Kearney; Jamie Krikham; Anna Lene Seidler; Helen Skouteris; Caroline B. Terwee; Sarah Redsell

doi:10.12688/hrbopenres.14108.1

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Study Protocol

Measurement properties of outcome measurement instruments used to measure caregiver feeding practices and feeding environment, infant diet, and infant anthropometry outcomes: Protocol for a systematic review

[version 1; peer review: 1 approved]

Karen Matvienko-Sikar ¹, Dimity Dutch¹, Moira Duffy¹, [...] Eibhlín Looney¹, Victoria Brown², John Browne¹, Darren Dahly^1,3, Declan Devane^4,5, Janas Harrington¹, Brittany J. Johnson⁶, Rebecca K. Golley⁶, Marian McBride⁷, Patricia Kearney¹, Jamie Krikham⁸, Anna Lene Seidler⁹, Helen Skouteris¹⁰, Caroline B. Terwee^11,12, Sarah Redsell¹³

Karen Matvienko-Sikar ¹, Dimity Dutch¹, [...] Moira Duffy¹, Eibhlín Looney¹, Victoria Brown², John Browne¹, Darren Dahly^1,3, Declan Devane^4,5, Janas Harrington¹, Brittany J. Johnson⁶, Rebecca K. Golley⁶, Marian McBride⁷, Patricia Kearney¹, Jamie Krikham⁸, Anna Lene Seidler⁹, Helen Skouteris¹⁰, Caroline B. Terwee^11,12, Sarah Redsell¹³

PUBLISHED 21 Mar 2025

Author details Author details

¹ University College Cork School of Public Health, Cork, County Cork, Ireland
² Deakin Health Economics, Deakin University Institute for Health Transformation, Burwood, Victoria, Australia
³ HRB Clinical Research Facility, Cork, County Cork, Ireland
⁴ School of Nursing and Midwifery, University of Galway, Galway, County Galway, Ireland
⁵ HRB Trials Methodology Research Network, University of Galway, Galway, County Galway, Ireland
⁶ Flinders University, College of Nursing and Health Sciences, Caring Futures Institute, Adelaide, South Australia, Australia
⁷ Health & Wellbeing, Strategy & Research, Healthcare Strategy, Health Service Executive, Dublin, County Dublin, Ireland
⁸ Centre for Biostatistics, Manchester Academic Health Service Centre, The University of Manchester, Manchester, England, UK
⁹ German Center for Child and Adolescent Health, Universitatsmedizin Rostock, Rostock, Germany
¹⁰ Health and Social Care Unit, Monash University School of Public Health and Preventive Medicine, Melbourne, Victoria, Australia
¹¹ Amsterdam UMC Location VUmc Department of Epidemiology and Biostatistics, Amsterdam, North Holland, The Netherlands
¹² Methodology, Amsterdam Public Health Research Institute, Amsterdam, North Holland, The Netherlands
¹³ University of Nottingham School of Health Sciences, Nottingham, England, UK

Karen Matvienko-Sikar
Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Dimity Dutch
Roles: Methodology, Writing – Review & Editing

Moira Duffy
Roles: Methodology, Writing – Review & Editing

Eibhlín Looney
Roles: Methodology, Writing – Review & Editing

Victoria Brown
Roles: Conceptualization, Methodology, Writing – Review & Editing

John Browne
Roles: Conceptualization, Methodology, Writing – Review & Editing

Darren Dahly
Roles: Conceptualization, Methodology, Writing – Review & Editing

Declan Devane
Roles: Conceptualization, Methodology, Writing – Review & Editing

Janas Harrington
Roles: Conceptualization, Methodology, Writing – Review & Editing

Brittany J. Johnson
Roles: Methodology, Writing – Review & Editing

Rebecca K. Golley
Roles: Conceptualization, Methodology, Writing – Review & Editing

Marian McBride
Roles: Conceptualization, Methodology, Writing – Review & Editing

Patricia Kearney
Roles: Conceptualization, Methodology, Writing – Review & Editing

Jamie Krikham
Roles: Conceptualization, Methodology, Writing – Review & Editing

Anna Lene Seidler
Roles: Methodology, Writing – Review & Editing

Helen Skouteris
Roles: Conceptualization, Methodology, Writing – Review & Editing

Caroline B. Terwee
Roles: Conceptualization, Methodology, Writing – Review & Editing

Sarah Redsell
Roles: Conceptualization, Methodology, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Maternal and Child Health collection.

Abstract

Background

How, what and when infants are fed in the first year of life influences their health and development. Interventions to improve infant feeding demonstrate inconsistent findings, highlighting a need for standardisation of what and how outcomes are measured. A core outcome set of infant feeding outcomes for use in childhood obesity prevention interventions has previously been developed, and scoping reviews have been conducted to identify what outcome measurement instruments are currently used to measure these outcomes. The aim of this review is to evaluate the measurement properties of the identified outcome measurement instruments that measure outcomes included in the infant feeding core outcome set.

Methods

A systematic review will be conducted following the COSMIN Initiative guidance. PubMed, EMBASE, CINAHL and PsycINFO databases will be searched from inception to present. To be eligible for inclusion studies must include infants ≤ 1 year of age. Studies must also report the development and/or evaluation of one or more measurement property of the outcome measurement instruments identified in our previous reviews, or other relevant outcome measurement instruments identified by the study team. Study screening and selection will be conducted independently in duplicate. The COSMIN Risk of Bias checklist will be used to evaluate the methodological quality of each study, and measurement properties will be evaluated one-by-one based on the COSMIN Initiative guidance. Confidence in the final ratings will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group approach. Results will be presented in narrative and tabular format.

Discussion

Evaluating measurement properties of outcome measurement instruments to measure outcomes included in the infant feeding core outcome set will inform development of a core outcome measurement set. This will standardise measurement in trials of infant feeding interventions to prevent childhood obesity, thus improving evidence synthesis and reducing research waste.

Keywords

outcome measurement instruments, measurement properties, feeding practices, diet, anthropometry, childhood obesity

Corresponding author: Karen Matvienko-Sikar

Competing interests: No competing interests were disclosed.

Grant information: Health Research Board [HRB-EIA-2022-005].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 Matvienko-Sikar K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Matvienko-Sikar K, Dutch D, Duffy M et al. Measurement properties of outcome measurement instruments used to measure caregiver feeding practices and feeding environment, infant diet, and infant anthropometry outcomes: Protocol for a systematic review [version 1; peer review: 1 approved]. HRB Open Res 2025, 8:43 (https://doi.org/10.12688/hrbopenres.14108.1) First published: 21 Mar 2025, 8:43 (https://doi.org/10.12688/hrbopenres.14108.1) Latest published: 21 Mar 2025, 8:43 (https://doi.org/10.12688/hrbopenres.14108.1)

Introduction

Infant feeding, in terms of how, what and when infants are fed in the first year of life, has important implications for child health and development. Infant feeding includes aspects such as the duration of breastfeeding, timing of introduction of solids, the feeding environment, and parent/caregiver feeding practices and styles^1–6. Infant feeding has been associated with development of diabetes^7,8, respiratory illnesses^7,8, allergic rhinitis⁹, cardiovascular diseases⁸, neurodevelopment⁷, and parent-child bonding and interactions⁸. Infant feeding is also suggested to be an important factor in the development and prevention of childhood obesity^6,10–13, which is a public health challenge with approximately 37 million children under the age of 5 years estimated to have overweight or obesity in 2022¹⁴. Childhood obesity is associated with significant adverse outcomes for the individual, including Type 2 diabetes, autoimmune diseases, cardiovascular disease, increased risk of premature mortality, and impaired mental health^15,16. Infant feeding behaviours, knowledge and attitudes have been targeted in childhood obesity prevention interventions^6,10,17–19. However, evidence of effectiveness of such interventions is inconsistent and it remains unclear what interventions work, for whom, and in what contexts^10,18,20,21.

One potential reason for inconsistency in existing findings is heterogeneity in the outcomes that are measured and reported^{10,20,22–24}. For instance, in a previous review examining what outcomes are measured in infant feeding studies, 236 individual outcomes were identified across 126 studies²³. Such heterogeneity limits evidence synthesis and contributes to research waste^10,25,26. To address this, two core outcome sets (COS) for childhood obesity prevention have been developed: an infant feeding COS for childhood obesity prevention, which includes 26 outcomes across nine outcome domains²⁴; and a complementary Early Prevention of Childhood Obesity (EPOCH) COS for children up to 5 years of age²². A COS represent the minimum set of outcomes that should be measured and reported in trials, and other research, in specific health areas²⁶. While these COS provide invaluable resources for what to measure, it is essential to provide guidance on how best to measure these outcomes²⁷. This is because the quality, feasibility, and availability of outcome measurement instruments (OMIs) have been cited as barriers to COS use by trialists²⁸. Further, the use of poor-quality OMIs can bias trial findings²⁹.

To provide recommendations on what OMIs should be used to measure core outcomes for childhood obesity prevention, core outcome measurement sets (COMS) are being developed for both previously developed COS^27,30,31. Three scoping reviews have been conducted to date to identify what OMIs have been used to measure the 26 outcomes included in the infant feeding COS²⁷. These scoping reviews form part of the Standardised measurement for Childhood Obesity Prevention (SCOPE) study³¹, and were conducted for outcomes related to caregiver feeding practices and feeding environment, infant diet, and infant anthropometric outcomes²⁷. Findings of the reviews identified over 200 OMIs currently used to measure 23 infant feeding COS outcomes. OMIs for three outcomes (knowing how to offer solid foods, caregiver modelling of eating behaviours, offering healthy foods) were not identified in the reviews, which focused on trials conducted in infancy; it is likely these outcomes have been measured in older children and/or in non-trial designs and work is ongoing to identify OMIs for these outcomes. In addition, OMIs identified in the reviews differ by type such as questionnaires, individual questions, dietary recall, food diaries/records, weighing scales, and callipers.

Given the volume and inconsistencies in OMIs used to measure the COS outcomes, evaluation of the measurement properties and other characteristics of these OMIs (e.g., feasibility) is necessary to develop the SCOPE COMS. The COnsensus-based Standards for health Measurement INstruments (COSMIN) Initiative provide guidance on the evaluation of OMIs^32–34. Following COSMIN Initiative guidance, systematic reviews of the literature on the development and validation of OMIs are an important tool to determine if the OMIs are valid, reliable, feasible and interpretable^33,35. The COSMIN Initiative provides criteria to evaluate measurement properties identified in development and validation studies³³. It also provides guidance on summarising and grading available evidence to make recommendations/suggestions about potentially suitable OMIs for use in future research³³. As such, the aim of this review is to systematically review the measurement properties and feasibility of the OMIs for infant (≤ 1 year) caregiver feeding practices and feeding environment, diet and anthropometric outcomes included in an infant feeding core outcome set for childhood obesity prevention.

Methods

The evaluation of measurement properties of OMIs identified in our previously conducted scoping reviews²⁷ will follow COSMIN Initiative guidelines³³. We will conduct a systematic review to identify evidence on measurement properties for established OMIs that have undergone measurement property testing. This protocol is reported in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P)³⁶. See Supplementary File 1 for PRISMA-P checklist³⁷. The review protocol is registered in the PROSPERO systematic review database (CRD420250650995).

Preliminary OMI screening

Over 200 OMIs were identified in our three scoping reviews²⁷, which is not a feasible number to examine for measurement properties. Therefore, a systematic approach will be taken to screen OMIs for inclusion in the current review. OMIs identified in our scoping reviews²⁷ will be sourced, if possible, including obtaining copies of questionnaires and details of objective measurements. Where OMIs are not found in the published papers identified in the previous reviews²⁷, study authors will be contacted and requested to provide the OMI used, with reminders sent if no reply is received. OMIs that cannot be obtained through literature searches or via contact with study authors will not be included in the screening and review stages. Screening of OMIs will be conducted using prespecified criteria including: 1) whether a recent review was conducted for the OMI following COSMIN guidelines^33,38 or rated as moderate to high quality using the AMSTAR 2 tool³⁹; 2) whether the OMI is fit for purpose (e.g., sufficient face and content validity); 3) whether the OMI is relevant for the population of interest; 4) whether the OMI is affordable to use; and 5) whether the OMI is practical to use. For this review, a 6^th criterion is related to whether the OMI could be used in both the infant feeding COMS³¹ and the EPOCH COMS³⁰. The EPOCH COMS is designed to be a complementary COMS for use beyond 12 months of age to measure outcomes included in a COS for early intervention trials to prevent obesity in childhood³⁰. Preliminary screening of OMIs will be done independently in duplicate, with any disagreements resolved by consensus or brought to a third reviewer. To ensure the needs and preferences of parents/caregivers are considered in the preliminary screening, Patient and Public Involvement (PPI) representatives pilot-tested the screening criteria with seven OMIs and will contribute to screening 20% of the OMIs in this review, in addition to the duplicate screeners. PPI representatives include mothers of infants ≤ 1 year old, with a range of infant feeding experiences. See Supplementary File 2 for full preliminary screening criteria and details.

Study eligibility. Study eligibility in the systematic reviews is determined by the constructs of interest, population, instrument type and measurement instruments (see Table 1). The constructs of interest are predetermined by those included in an infant feeding COS for childhood obesity prevention²⁴. See Supplementary File 3 for details of outcomes and their definitions. The population is infants ≤ 1 year of age. The instrument types are also predetermined by our previous scoping reviews²⁷ and the results of preliminary screening stage.

Table 1. Study eligibility criteria.

Construct of interest	The OMI should measure one of the 26 outcomes included in an infant feeding core outcome set for childhood obesity prevention²⁴. The outcomes and their definitions are included in Supplementary File 3.
Population	Infants ≤ 1 year of age, born at full-term and not less than 37 weeks’ gestation; as per COSMIN Initiative guidelines, this should consist of at least 50% of the study population. Where it is unclear if at least 50% of infants were born at full term, study authors will be contacted for this information.
Instrument type	OMIs identified in our previous reviews²⁷, and any other relevant OMIs identified by the study team, including additional OMIs provided by contacted study authors, will be eligible for inclusion. These OMIs include, for example, questionnaires, single survey items, food diaries, dietary recall, weighing scales, callipers, air displacement plethysmography.
Measurement properties	Eligible papers must report on development and/or evaluation of one or more measurement property of the previously identified OMIs²⁷: content validity, structural validity, cross-cultural validity, internal consistency, reliability, measurement error, construct validity, criterion validity, responsiveness.

Inclusion criteria: Studies must report on the development and/or evaluation of one or more measurement properties of previously identified OMIs that are used to measure an outcome included in the infant feeding core outcome set²⁴. At least 50% of the study population must include infants ≤ 1 year of age, born at full-term. Only published full-text papers will be included as the likelihood of identifying comprehensive information on measurement properties in other types of publications (e.g. abstracts or reviews) is considered small³³. English-language only publications will be eligible for inclusion but will be no restrictions on location or date of publication.

Exclusion criteria: Studies that do not meet the inclusion criteria, that report on development and evaluation of an OMI that is not included in the review search, or that report using an OMI as a comparison tool for validation of another OMI will also be excluded.

Search strategy. PubMed, EMBASE, CINAHL and PsycINFO databases will be searched from inception to present. Summary search blocks are presented in Table 2, full search terms are presented in Supplementary File 4. Reference lists of identified papers will also be searched to ensure all studies are identified.

Table 2. Summary search blocks.

Population	Terms related to infancy
[AND] Measurement properties	COSMIN sensitive search filter for measurement properties, which includes terms related to all measurement properties⁴⁰
[AND] Instrument names	Pre-identified caregiver infant-feeding practices and feeding environment OMI names (Search 1) Pre-identified diet OMI names (Search 2) Anthropometric OMI names (search 3)
[NOT]	COSMIN Exclusion filter to remove irrelevant studies, e.g., animal studies and case reports⁴⁰

Study screening and selection. Identified studies from each search will be downloaded and deduplicated using Covidence software. Covidence software will also be used for study screening. All titles and abstracts of identified studies will be independently screened in duplicate against inclusion/exclusion criteria. Full texts of potentially eligible studies will then be screened independently and in duplicate. Any discrepancies at either screening stage will be resolved through consensus discussion or recourse to a third reviewer if needed.

Data extraction. Data extraction is informed by COSMIN Initiative guidance³³ and the COSMIN taxonomy of measurement properties^29,33. Extracted data will include: study and participant characteristics (title, author, year of publication, country, language, setting, participant type (e.g., child, caregiver, healthcare professional), age, gender, and sample size); OMI characteristics (name, version, OMI language, construct measured, target population, intended context of use, number of items, response options, possible range of scoring, scoring algorithm, measurement model, recall period, measurement properties, and how well the scope of the OMI has been described); feasibility characteristics (time to administer, OMI openly available, licensing information, costs, available translations; interpretability characteristics (percentage of patients with lowest and highest scores, number of items with missing values, minimal important change/minimal important difference, credibility score). Measurement property data to be extracted, if reported, include data on face and content validity, structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity (e.g., doubly labelled water as a gold standard for energy intake), construct validity (e.g., associations between breastfeeding duration and child anthropometric outcomes), and responsiveness. Different data will be extracted depending on the OMIs used, e.g., data on a number of items, recall period, and internal consistency may not be applicable to objective anthropometric OMIs. Data extraction will be conducted using the COSMIN review management file (https://www.cosmin.nl/tools/guideline-conducting-systematic-review-outcomemeasures/). Pilot data extraction will be conducted independently by two reviewers with a subset of studies to ensure the data extraction form is fit for purpose. All subsequent data extraction will be conducted by a single reviewer, and all extracted data will be checked by a second reviewer.

Quality assessment. The COSMIN Risk of Bias checklist⁴¹ will be used to evaluate the methodological quality of each study, with studies evaluated as very good, adequate, doubtful or inadequate. The COSMIN Risk of Bias tool includes standards referring to design requirements and preferred statistical methods. It adopts a “worst score counts” principle whereby the lowest rating for any quality standard determines the overall rating⁴¹. Quality assessment will be conducted by two reviewers independently and in duplicate, with any disagreements resolved by consensus discussion or recourse to a third reviewer as needed. The COSMIN criteria for good measurement properties³³ will be applied by two reviewers independently in duplicate, with results rated as sufficient (+), insufficient (-) or indeterminate (?).

Evaluating measurement properties of the OMIs. Measurement properties of identified OMIs will be evaluated one-by-one, starting with content validity, based on the COSMIN Initiative guidance³³. Reliability, measurement error, criterion validity, hypotheses testing for construct validity and responsiveness will be examined as appropriate. The review team will define hypotheses for evaluating construct validity and responsiveness as recommended in the COSMIN guidance³³. The measurement properties for each OMI will then be summarised as per COSMIN Initiative guidance for consistent and inconsistent study results³³. Results will be summarised by one reviewer and checked by a second reviewer. Summarised results will then be rated independently by two reviewers using the COSMIN criteria for good measurement properties, with summarised results rated as sufficient (+), insufficient (-), or indeterminate (?).

Certainty assessment. Confidence in the final ratings will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group approach to grading the quality of the evidence^33,42. Four factors are considered when grading the quality of the evidence for OMIs, namely the risk of bias, inconsistency of results, imprecision (e.g., total sample size), and indirectness (e.g., evidence from different populations)³³. Following the GRADE approach, evidence is downgraded to moderate, low, or very low evidence when there is a risk of bias, unexplained inconsistency, indirect results, or imprecision. The evidence can be downgraded to very low when the evidence is based on one inadequate study only³³. Grading the quality of the evidence will be done by two reviewers independently, with any discrepancies resolved by consensus discussion or recourse to a third reviewer.

Reporting. The summary of the evidence, based on the results of reviewed studies and the graded quality of the evidence on the measurement properties of OMIs, will be presented in the three respective review papers: 1) caregiver infant-feeding practices and feeding environment outcomes, 2) diet outcomes, and 3) anthropometric outcomes. The summary of the results, overall rating of the summarised result (sufficient, insufficient or indeterminate), and the quality of the evidence will be presented narratively and in tabular format. OMIs will be categorised as: a) suggested for use; b) potentially suggested for use; and c) not suggested for use. Findings will be reported following the PRISMA-COSMIN guideline for reporting of systematic reviews of OMI³².

Discussion

Evaluation of the measurement properties of OMIs that are currently used to measure core feeding practices and environment, diet, and anthropometric outcomes is essential to inform the development of a COMS. Following the evaluation of measurement properties, the next step is to conduct prioritisation and consensus processes with key stakeholders through an e-Delphi and consensus meeting, respectively. These processes will be conducted following the evaluation of OMI measurement properties as outlined here by bringing those OMIs categorised as suggested for use and potentially suggested for use forward to the e-Delphi survey, with the results of the e-Delphi survey informing the consensus meeting. The findings of these reviews and the subsequent consensus processes will, therefore, lead to the finalisation of the infant feeding COMS for childhood obesity prevention. Developing and using a COMS can standardise OMIs used in trials of infant feeding interventions to prevent childhood obesity, which will improve evidence synthesis and reduce research waste in this area.

Ethical considerations

As this is a systematic review, there are no potential ethical issues. As such, ethical approval is not required.

Dissemination

Findings from this study will be disseminated as three review publications based on the following groupings: caregiver feeding practices and environment OMIs, child diet OMIs, and child anthropometric OMIs. Findings will also be disseminated as presentations at academic conferences.

Data availability

Underlying data

No data are associated with this article.

Extended data

Open Science Framework: Measurement properties of outcome measurement instruments used to measure caregiver feeding practices and feeding environment, infant diet, and infant anthropometry outcomes, https://doi.org/10.17605/OSF.IO/UAXGK³⁷.

This project contains the following extended data:

- Supplementary file 1: PRISMA-P checklist
- Supplementary file 2: Screening criteria
- Supplementary file 3: COS outcomes and definitions
- Supplementary file 4: Search strategy

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgements

We would like to thank the members of the PPI group who have kindly contributed to pilot-testing the preliminary screening criteria for use in this review and their continued involvement in screening OMIs.

Faculty Opinions recommended

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