Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000598189
Ethics application status
Approved
Date submitted
21/02/2019
Date registered
17/04/2019
Date last updated
6/04/2020
Date data sharing statement initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mealtimes Matter: Childcare as window into food insecurity and food socialisation in low-income communities
Scientific title
Observation of feeding practices and eating behaviors of children in childcare in low income communities
Secondary ID [1] 297462 0
None
Universal Trial Number (UTN)
Trial acronym
Mealtimes Matter
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children's eating behaviors; including food fussiness 311651 0
Condition category
Condition code
Diet and Nutrition 310273 310273 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Mealtimes in Early Childhood Education Centres (ECEC services) will be observed. In situ observations of childcare mealtime practices will be conducted approximately 4-weeks after the online survey will be completed by parents (this survey has been developed for the purpose of this study and includes standard items regarding food secutiry, feeding practices and children's fussy eating behaviours).

Observations using standard tools will capture six areas of mealtime practice: (1) mealtime structure, (2) child-educator relational quality, (3) restriction and reward, (4) meal content and timing, (5) child eating behaviours, and (6) feeding practices. Observations of practices,
child behaviour, child-educator interactions, and educator behaviour will be conducted over 1 to 2 days within each service.
Intervention code [1] 313718 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319171 0
Mealtime and feeding practices in Early Childhood Education Centres (ECEC). Measured via the Environmental Policy Assessment and Observation (EPAO)[1]. Selected items will be used to examine nutrition, feeding practices and behaviours in each service during mealtimes and be used to evaluate photographs taken of participating children's meals.

[1] Ward, D., Hales, D., Haverly, K., Marks, J., Benjamin, S., Ball, S., & Trost, S. (2008). An instrument to assess the obesogenic environment of child care centers. American Journal of Health Behaviour, 32(4), 380-386.
Timepoint [1] 319171 0
During observational ECEC site visit; observations will be collected over one or two days at each ECEC service.
Primary outcome [2] 319177 0
Mealtime and feeding practices in ECEC services, measured via the*Environmental Policy Assessment and Observation extended version (Expanded Feeding Practices; EPAO-EFP)[2, 3]. Selected items will be used to examine educator feeding practices.

[2] Halloran, K. M. (2016). Head start teacher nutrition knowledge, attitudes and diet as predictors of classroom mealtime behaviors with children (Doctoral dissertation). Retrieved from https://digitalcommons.uri.edu/oa_diss/433/

[3] Fallon, M., Halloran, K., Gorman, K., Ward, D., Greene, G., & Tovar, A. (2018). Self-reported and observed feeding practices of Rhode Island Head Start teachers: Knowing what not to do. Appetite, 120, 310-317. doi: 10.1016/j.appet.2017.09.009
Timepoint [2] 319177 0
During observational ECEC site visit; observations will be collected over one or two days at each ECEC service.
Primary outcome [3] 319178 0
Mealtime and feeding practices in Early Childhood Education Centres (ECEC). Measured via the Family Mealtime Coding System (FMCS)[4] adapted to be used in ECEC settings to examine educators' feeding practices with target children. Constitutes measurement of frequency of observed behaviours (e.g., physical prompt, use of incentives).

[4] Haycraft, E. L., & Blissett, J. M. (2008). Maternal and paternal controlling feeding practices: Reliability and relationships with BMI. Obesity, 16(7), 1552-1558.
Timepoint [3] 319178 0
During observational ECEC site visit; observations will be collected over one or two days at each ECEC service.
Secondary outcome [1] 367174 0
Feeding Practices and Structure Questionnaire (FPSQ)[5] assesses home feeding practices and mealtime structure.

[5] Jansen, E., Harris, H. A., Mallan, K.M., Daniels, L., & Thorpe, K. (2017). Measurement invariance of the feeding practices and Structure Questionnaire-28 among a community of socioeconomically disadvantaged mothers and fathers. Appetite, 120, 115-122. doi: 10.1016/j.appet.2017.08.030
Timepoint [1] 367174 0
Parent survey will be completed approximately 4-weeks prior to observational site visit.
Secondary outcome [2] 367175 0
The Hunger Vital Sign 2-item questionnaire [6] assesses food insecurity at home.

[6] Hager, E. R., Quigg, A. M., Black, M. M., Coleman, S. M., Heeren, T., Rose-Jacobs, R., … Frank, D. A. (2010). Development and validity of a 2-item screen to identify families at risk for food insecurity. Pediatrics, 126(1), e26-e32. doi: 10.1542/peds.2009-3146
Timepoint [2] 367175 0
Parent survey will be completed approximately 4-weeks prior to observational site visit.
Secondary outcome [3] 367176 0
Household Food and Nutrition Security Scale (HFNSS) [7, 8] also assesses food security at home,

[7] Kleve, S., Gallegos, D., Ashby, S., Palermo, C., & McKechnie, R. (2018). Preliminary Validation and Piloting of a Comprehensive Measure of Household Food Security in Australia. Public Health Nutrition, 21(3), 526–534. doi: 10.1017/S1368980017003007
[8] Archer, C., Gallegos, D., & McKechnie, R. (2017). Developing measures of food and nutrition security within an Australian context. Public Health Nutrition, 20(14), 2513-2522. doi:10.1017/S1368980017001288
Timepoint [3] 367176 0
Parent survey will be completed approximately 4-weeks prior to observational site visit.
Secondary outcome [4] 367177 0
Child Eating Behaviour Questionnaire (CEBQ) [9] assesses the child's eating behaviour at home.

[9] Wardle, J., Guthrie, C. A., Sanderson, S., & Rapoport, L. (2001). Development of the Children's Eating Behaviour Questionnaire. Journal of Child Psychology and Psychiatry, 42(7), 963-970. doi: 10.1111/1469-7610.00792
Timepoint [4] 367177 0
Parent survey will be completed approximately 4-weeks prior to observational site visit.
Secondary outcome [5] 367184 0
Children's Dietary Questionnaire [10] assesses the child's intake patterns of foods for which intake is recommended (positive indicators - fruit, vegetables, water, reduced fat products) and foods for which intake is discouraged (negative indicators - high fat/sugar foods [non-core foods], sweetened beverages and full fat dairy products).

[10] Magarey, A., Golley, R., Spurrier, N., Goodwin, E., & Ong, F. (2009). Reliability and validity of the Children's Dietary Questionnaire; a new tool to measure children's dietary patterns. International Journal of Pediatric Obesity, 4(4), 257-265. doi: 10.3109/17477160902846161
Timepoint [5] 367184 0
Parent survey will be completed approximately 4-weeks prior to observational site visit.
Secondary outcome [6] 367188 0
Anthropometric measurement of each child's height, weight, and waist circumference will be conducted as per the WHO standard protocols, with scores used to provide a composite measure - Body Mass Index (BMI) Z-scores.
Timepoint [6] 367188 0
During observational ECEC site visit; observations will be collected over one or two days at each ECEC service.
Secondary outcome [7] 367192 0
Individualised Classroom Assessment Scoring System (inCLASS) [11] assesses individual child behaviour within a class context in rotations of observations of 4 children (15 minute cycles/ child). Three measures are generated – task engagement, engagement with educator, engagement with peers. During mealtimes, target children selected from each service will be observed during the mealtime periods. Random selection of target children from the pool of consenting children, attending to gender and parental ratings of children’s food fussiness, will be conducted.

[11] Downer J, Booren L, Lima O, Luckner A, Pianta R. (2010). The Individualized Classroom Assessment Scoring System (inCLASS). Early Childhood Research Quarterly, 25(1), 1-16. doi: 10.1016/j.ecresq.2009.08.004
Timepoint [7] 367192 0
During observational ECEC site visit; observations will be collected over one or two days at each ECEC service.

Eligibility
Key inclusion criteria
Inclusion criteria at the service level will include services located in Logan City (Queensland, Australia) with a 3-5 age group room. Inclusion criteria at the child level will include enrolment in the 3-5 age group room.

Parents must be 18-years or older and are required to read and complete questionnaires in English (or seek assistance from the research team over the phone). Families who do not have proficient English will be consulted through community liaison officers as per protocols used in prior studies. The definition of parent is not limited to biological parents, but includes a main caregiver of the child, extending to step-, adoptive- or grand-parents.
Minimum age
3 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Mediation analyses will be conducted to examine the relationship between parent feeding practices, childcare practices and child fussy eating behaviours.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/05/2019
Actual
18/07/2019
Date of last participant enrolment
Anticipated
Actual
14/11/2019
Date of last data collection
Anticipated
Actual
29/11/2019
Sample size
Target
100
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 302031 0
Other Collaborative groups
Name [1] 302031 0
The Life Course Centre
Country [1] 302031 0
Australia
Primary sponsor type
Individual
Name
Professor Karen Thorpe
Address
The University of Queensland
Institute of Social Sciences Research
Level 2, Cycad Building (1018)
80 Meiers Rd
Indooroopilly Queensland 4068 Australia
Country
Australia
Secondary sponsor category [1] 301830 0
Individual
Name [1] 301830 0
Dr Sally Staton
Address [1] 301830 0
The University of Queensland
Institute of Social Sciences Research
Level 2, Cycad Building (1018)
80 Meiers Rd
Indooroopilly Queensland 4068 Australia
Country [1] 301830 0
Australia
Secondary sponsor category [2] 301846 0
Individual
Name [2] 301846 0
Dr Holly Harris
Address [2] 301846 0
School of Public Health, The University of Queensland
266 Herston Rd,
Herston Queensland 4006 Australia
Country [2] 301846 0
Australia
Secondary sponsor category [3] 301847 0
Individual
Name [3] 301847 0
Associate Professor Alina Morawska
Address [3] 301847 0
Parenting and Family Support Centre
The University of Queensland
19/13 Upland Rd,
St Lucia Queensland 4067 Australia
Country [3] 301847 0
Australia
Secondary sponsor category [4] 301848 0
Individual
Name [4] 301848 0
Associate Professor Cameron Parsell
Address [4] 301848 0
The University of Queensland, UQ Development Fellow. Associate with:
Institute of Social Sciences Research
Level 2, Cycad Building (1018)
80 Meiers Rd
Indooroopilly Queensland 4068 Australia
Country [4] 301848 0
Australia
Secondary sponsor category [5] 301849 0
Individual
Name [5] 301849 0
Professor Danielle Gallegos
Address [5] 301849 0
School of Exercise and Nutrition Sciences, Queensland University of Technology
O Block, Room O-A409
Kelvin Grove
Victoria Park Road
Kelvin Grove QLD 4059
Country [5] 301849 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302712 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 302712 0
Ethics committee country [1] 302712 0
Australia
Date submitted for ethics approval [1] 302712 0
Approval date [1] 302712 0
08/02/2019
Ethics approval number [1] 302712 0
2018002381

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91134 0
Prof Karen Thorpe
Address 91134 0
INSTITUTE OF SOCIAL SCIENCES RESEARCH
80 Meiers Rd, Indooroopilly QLD 4068
Country 91134 0
Australia
Phone 91134 0
+61 7 3346 7742
Fax 91134 0
Email 91134 0
[email protected]
Contact person for public queries
Name 91135 0
Karen Thorpe
Address 91135 0
INSTITUTE OF SOCIAL SCIENCES RESEARCH
80 Meiers Rd, Indooroopilly QLD 4068
Country 91135 0
Australia
Phone 91135 0
+61 7 3346 7742
Fax 91135 0
Email 91135 0
[email protected]
Contact person for scientific queries
Name 91136 0
Karen Thorpe
Address 91136 0
INSTITUTE OF SOCIAL SCIENCES RESEARCH
80 Meiers Rd, Indooroopilly QLD 4068
Country 91136 0
Australia
Phone 91136 0
+61 7 3346 7742
Fax 91136 0
Email 91136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.