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Trial registered on ANZCTR


Registration number
ACTRN12620000459921
Ethics application status
Approved
Date submitted
19/03/2020
Date registered
8/04/2020
Date last updated
8/04/2020
Date data sharing statement initially provided
8/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel methods of infant feeding in New Zealand - cause for concern or optimism?
Scientific title
Novel methods of infant feeding in New Zealand - an observational study of the impact of baby food pouches and baby-led weaning on iron status and body mass index
Secondary ID [1] 300760 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FFNZ (First Foods New Zealand)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron status 316702 0
Body mass index (BMI) 316703 0
Condition category
Condition code
Blood 314943 314943 0 0
Other blood disorders
Diet and Nutrition 314944 314944 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
From the baseline visit (between 7.0 and 9.9 months of age) to approximately 2 weeks after the baseline visit, we will collect data on infant feeding (including retrospective information about complementary feeding practices), choking, oral motor skills, use of culturally important foods, and parents’ attitudes around environmental sustainability aspects of infant feeding (questionnaire); dietary intake (two 24-hour recalls with photographic prompts); body mass index (length and weight); eating behaviours (questionnaire and video recording), iron status (blood test), and dental health (photographs of infant’s teeth).
For a subsample of breastfeeding mother-infant dyads, we will also obtain accurate data on the amount of breast milk infants consume using the stable isotope (deuterium oxide) ‘dose-to-mother’ technique. We will also analyse the nutrient content of the mother's breast milk using an expressed breast milk sample.
Intervention code [1] 317147 0
Not applicable
Comparator / control treatment
Observational study – No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323258 0
Mean plasma ferritin concentration measured by assay
Timepoint [1] 323258 0
Approximately 2 weeks after baseline visit
Primary outcome [2] 323259 0
Mean BMI z-score calculated using World Health Organization reference data
Timepoint [2] 323259 0
Baseline visit (between 7.0 and 9.9 months of age)
Secondary outcome [1] 381325 0
Prevalence of frequent food pouch use assessed via questionnaire, developed specifically for this study
Timepoint [1] 381325 0
Baseline visit (between 7.0 and 9.9 months of age)
Secondary outcome [2] 381326 0
Prevalence of Baby-Led Weaning (BLW) assessed via questionnaire (Fu et al., Appetite 1(130):110-6, 2018)
Timepoint [2] 381326 0
Baseline visit (between 7.0 and 9.9 months of age)
Secondary outcome [3] 381327 0
Prevalence of iron deficiency anaemia assessed using iron status categories defined using haemoglobin (measured on venous blood via automated analyser), body iron (calculated as the log ratio of soluble transferrin receptor to plasma ferritin concentration)
Timepoint [3] 381327 0
Approximately 2 weeks after baseline visit
Secondary outcome [4] 381328 0
Prevalence of iron deficiency assessed using iron status categories defined using haemoglobin (measured on venous blood via automated analyser), body iron (calculated as the log ratio of soluble transferrin receptor to plasma ferritin concentration)
Timepoint [4] 381328 0
Approximately 2 weeks after baseline visit
Secondary outcome [5] 381329 0
Prevalence of iron depletion assessed using iron status categories defined using haemoglobin (measured on venous blood via automated analyser), body iron (calculated as the log ratio of soluble transferrin receptor to plasma ferritin concentration), and plasma ferritin (measured by assay) concentrations
Timepoint [5] 381329 0
Approximately 2 weeks after baseline visit
Secondary outcome [6] 381330 0
Food and nutrient intake assessed using two 24-h recalls and a questionnaire designed specifically for this study
Timepoint [6] 381330 0
Baseline visit (between 7.0 and 9.9 months of age) (first 24-h recall and questionnaire) + approximately 1 week after baseline visit (second 24-h recall)
Secondary outcome [7] 381331 0
Energy self-regulation assessed using two subscales from the Children’s Eating Behaviour Questionnaire (CEBQ), which measure satiety responsiveness (eating appropriately in response to appetite) and food responsiveness (eating in response to environmental food cues rather than hunger)
Timepoint [7] 381331 0
Baseline visit (between 7.0 and 9.9 months of age)
Secondary outcome [8] 381332 0
Food fussiness assessed using the five items in the “picky eating” subscale of the Toddler-Parent Mealtime Behavior Questionnaire
Timepoint [8] 381332 0
Baseline visit (between 7.0 and 9.9 months of age)
Secondary outcome [9] 381333 0
Caregiver responsiveness to child feeding cues relevant to obesity measured by coding video documentation of the baby’s (non-milk) evening meal using the Responsiveness to Child Feeding Cues Scale (Hodges et al. Appetite 65;210-9, 2013)
Timepoint [9] 381333 0
Approximately 2 weeks after baseline visit
Secondary outcome [10] 381334 0
Choking assessed using a questionnaire that was adapted from a previously validated questionnaire (Fangupo et al. 138(4), 2016)
Timepoint [10] 381334 0
Baseline visit (between 7.0 and 9.9 months of age)
Secondary outcome [11] 381335 0
Dental caries assessed by examination of photographs of the infant’s teeth by a single blinded registered dental practitioner, with blinded evaluation of a subset by another examiner, using validated indices for caries
Timepoint [11] 381335 0
Approximately 1 week after baseline visit
Secondary outcome [12] 381336 0
Developmental defects of enamel assessed by examination of photographs of the infant’s teeth by a single blinded registered dental practitioner, with blinded evaluation of a subset by another examiner, using validated indices for developmental defects of enamel
Timepoint [12] 381336 0
Approximately 1 week after baseline visit
Secondary outcome [13] 381486 0
Amount of breast milk infants consume assessed using the stable isotope (deuterium oxide) ‘dose-to-mother’ technique in a subsample of breastfeeding mother-infant dyads
Timepoint [13] 381486 0
Approximately 2 weeks after baseline visit
Secondary outcome [14] 381487 0
Oral motor skills assessed using the Child Oral and Motor Proficiency Scale (ChOMPS) and the Pediatric Eating Assessment Tool (PediEAT)
Timepoint [14] 381487 0
Approximately 2 weeks after baseline visit
Secondary outcome [15] 381501 0
Cost of infant feeding for baby food pouch users assessed by assigning costs to foods and drinks reported in two 24-hour recalls
Timepoint [15] 381501 0
Baseline visit (between 7.0 and 9.9 months of age) (first 24-h recall) + approximately 1 week after baseline visit (second 24-h recall)

Eligibility
Key inclusion criteria
* Parents or guardians are 16 years of age or older, and
* Live in Auckland, Wellington or Dunedin (New Zealand), and
* Infant is 7.0 to 9.9 months of age
Minimum age
7 Months
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Parent or guardian is not able to communicate in English
* Infant has participated in a nutrition intervention study in which parents were asked to change the way in which the infant was fed

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Our sample size calculation is based on comparing serum ferritin concentration and BMI z-score in infants following BLW and traditional spoon feeding (TSF) as there are currently no data on pouch use. Our recent studies suggest 29% of infants will meet the definition of BLW (Fu et al., Appetite 1(130):110-6, 2018) and 70% of enrolled infants will provide a blood sample (Daniels et al., BMJ Open 8(6), 2018). A recruitment size of 625 would therefore enable us to collect complete data from 125 BLW and 312 TSF infants – sufficient to detect 5 micrograms/L lower serum ferritin concentration in the BLW group assuming a SD of 17 micrograms/L in TSF (Daniels et al., BMJ Open 8(6), 2018); and a difference of 0.3 BMI z-score, both with 80% power and alpha = 0.05. With a sample size of 625, we will be able to estimate the prevalence of frequent pouch use to a 95% precision level of at least +/- 4%.
Regression models will be used to determine differences between groups. Propensity score matching will be undertaken to try and remove bias caused by differences in demographics between the groups (e.g., maternal education), infant age (to the nearest week) and sex. Estimates of BLW, frequent pouch use, nutrient intake, status, and adequacy will be calculated for the whole sample along with 95% confidence intervals. If the sample is not demographically representative of the wider population, statistical weighting of these estimates will be undertaken using the survey command in Stata (StataCorp, Texas).
Adequacy of nutrient intake will be assessed using 24-hour recall data adjusted to provide estimates of usual intake (using the Multiple Source Method (Harttig et al., Eur J Clin Nutr 65:S87-91, 2011)). The BRINDA method (Diana et al., Br J Nutr 118(10):830-9) will be used to adjust plasma ferritin, and therefore body iron and iron status, for the impact of inflammation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22441 0
New Zealand
State/province [1] 22441 0

Funding & Sponsors
Funding source category [1] 305221 0
Government body
Name [1] 305221 0
Health Research Council of New Zealand
Address [1] 305221 0
Health Research Council of New Zealand, PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 305221 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Anne-Louise Heath
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 305579 0
Individual
Name [1] 305579 0
Professor Rachael Taylor
Address [1] 305579 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country [1] 305579 0
New Zealand
Other collaborator category [1] 281242 0
Individual
Name [1] 281242 0
Dr Jillian Haszard
Address [1] 281242 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country [1] 281242 0
New Zealand
Other collaborator category [2] 281243 0
Individual
Name [2] 281243 0
Dr Lisa Te Morenga
Address [2] 281243 0
Faculty of Health
Victoria University of Wellington
PO Box 600
Wellington 6140
Country [2] 281243 0
New Zealand
Other collaborator category [3] 281244 0
Individual
Name [3] 281244 0
Dr Cathryn Conlon
Address [3] 281244 0
College of Health
Massey University
Private Bag 102904
Auckland 0745
Country [3] 281244 0
New Zealand
Other collaborator category [4] 281245 0
Individual
Name [4] 281245 0
Dr Kathryn Beck
Address [4] 281245 0
College of Health
Massey University
Private Bag 102904
Auckland 0745
Country [4] 281245 0
New Zealand
Other collaborator category [5] 281246 0
Individual
Name [5] 281246 0
Associate Professor Pamela von Hurst
Address [5] 281246 0
College of Health
Massey University
Private Bag 102904
Auckland 0745
Country [5] 281246 0
New Zealand
Other collaborator category [6] 281247 0
Individual
Name [6] 281247 0
Mrs Alison Meldrum
Address [6] 281247 0
Department of Oral Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country [6] 281247 0
New Zealand
Other collaborator category [7] 281248 0
Individual
Name [7] 281248 0
Professor Lisa Houghton
Address [7] 281248 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country [7] 281248 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305568 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 305568 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 305568 0
New Zealand
Date submitted for ethics approval [1] 305568 0
30/07/2019
Approval date [1] 305568 0
13/11/2019
Ethics approval number [1] 305568 0
19/STH/151

Summary
Brief summary
Researchers, health professionals, and policy makers know surprisingly little about how and what infants are fed during their remarkable journey from consuming a 100% milk diet at birth, to consuming the same foods as their family around their first birthday. In fact, we don’t know what babies are eating in New Zealand even though there has been a revolution in infant feeding with domination of the market by baby food ‘pouches’, and massive uptake of BLW, a virtually unstudied approach to introducing solids in which babies feed themselves only finger foods from the start of complementary feeding.
The First Foods New Zealand study will determine the impact of pouches and BLW on iron deficiency, growth, choking, oral motor skills and dental health in an observational study of 625 Dunedin, Wellington and Auckland infants. The study will also investigate culturally important foods for Maori and Pacific Island people, as well as other ethnicities; investigate parent attitudes surrounding environmental sustainability aspects of infant feeding; and investigate the cost of infant feeding for baby food pouch users. The results will enable the Ministry of Health, health professionals, and Plunket to advise New Zealand parents on how to introduce solids safely.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100802 0
A/Prof Anne-Louise Heath
Address 100802 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 100802 0
New Zealand
Phone 100802 0
+64 3 479 8379
Fax 100802 0
Email 100802 0
anne-louise.heath@otago.ac.nz
Contact person for public queries
Name 100803 0
A/Prof Anne-Louise Heath
Address 100803 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 100803 0
New Zealand
Phone 100803 0
+64 3 479 8379
Fax 100803 0
Email 100803 0
anne-louise.heath@otago.ac.nz
Contact person for scientific queries
Name 100804 0
A/Prof Anne-Louise Heath
Address 100804 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 100804 0
New Zealand
Phone 100804 0
+64 3 479 8379
Fax 100804 0
Email 100804 0
anne-louise.heath@otago.ac.nz

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 other documents available
Summary results
No Results