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Trial registered on ANZCTR


Registration number
ACTRN12620000670976
Ethics application status
Approved
Date submitted
4/05/2020
Date registered
12/06/2020
Date last updated
12/06/2020
Date data sharing statement initially provided
12/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Real-world implementation, effectiveness and cost-effectiveness of INFANT: an evidence-based program addressing lifestyle behaviours from the start of life
Scientific title
Real-world implementation, effectiveness and cost-effectiveness of the Infant Feeding, Activity and Nutrition (INFANT) Program
Secondary ID [1] 300187 0
National Health and Medical Research Council (ID number: APP1161223).
Universal Trial Number (UTN)
U1111-1246-0893
Trial acronym
Large-scale INFANT
Linked study record
The Infant Feeding Activity and Nutrition Trial (INFANT) - ISRCTN81847050
This record is the original INFANT RCT that the current INFANT scale-up and embedded effectiveness trial is based upon.

Health condition
Health condition(s) or problem(s) studied:
Infant feeding 315742 0
Physical activity 315743 0
Sedentary behaviours 315744 0
Nutrition 315745 0
Child overweight and obesity 315747 0
Condition category
Condition code
Public Health 314021 314021 0 0
Health promotion/education
Diet and Nutrition 314023 314023 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Access to free routine Maternal and Child Health Services (available for all Victorian families with children from birth to school age) and INFANT. INFANT will consist of four face-to-face group-based sessions of approximately 8-15 parents during their baby's first year, complemented with the My Baby Now app/website.

Face-to-face group sessions
Face-to face program of four 1.5-hour sessions at infant age 3, 6, 9, 12 months delivered by trained service providers of organisations delivering INFANT. Service providers eligible to be facilitators include maternal and child health nurses, dietitians, community health workers or nominated delegates from service providers. Sessions focus on anticipatory guidance-based parental knowledge, skills, and social support around infant feeding, diet, active play, and sedentary behaviours to encourage healthy habits from the very start of life.

Mobile app/website (My Baby Now)
A smart-phone app/website (My Baby Now) has been developed to complement face-to-face delivery by providing ‘around the clock’, high-quality information and personalised/tailored support. The app contains the original INFANT content and also provides guidance on breastfeeding, best practice formula feeding and sleep with additional information up until child age 18 months of age. The app has been developed based on extensive formative work and a feasibility study of an earlier version of the app.

Adherence to the intervention will be monitored through group session attendance records (recorded by facilitators), and parent/caregiver self-report at 12 and 18 month surveys. App analytics will also be monitored to examine parent/caregiver engagement with the app.
Intervention code [1] 316465 0
Behaviour
Intervention code [2] 316466 0
Prevention
Comparator / control treatment
Access to free routine Maternal and Child Health Services (available for all Victorian families with children from birth to school age).
Control group
Active

Outcomes
Primary outcome [1] 322432 0
Child lifestyle pattern score ‘Discretionary food and screen time’ (a composite measure of child diet, physical activity and screen time), assessed using parent/caregiver reported survey/questionnaire measures.

Lifestyle patterns scores have been derived from previous INFANT trials:
Lioret S, Campbell KJ, McNaughton SA, Cameron AJ, Salmon J, Abbott G, Hesketh KD: Lifestyle patterns begin in early childhood, persist and are socioeconomically patterned, confirming the importance of early life interventions. Nutrients 2020, 12(3).
Timepoint [1] 322432 0
18 months of age
Secondary outcome [1] 378528 0
Child diet (fruit, vegetables, non-core drinks and snacks), measured using a parent/caregiver reported validated Food Frequency Questionnaire (FFQ).
Timepoint [1] 378528 0
12 and 18 months of age
Secondary outcome [2] 378529 0
Child time physically active, assessed using parent/caregiver self-reported INFANT-specific surveys/questionnaires used in previous INFANT trials.
Timepoint [2] 378529 0
12 and 18 months of age
Secondary outcome [3] 379221 0
Child time sedentary (screen time), assessed using parent/caregiver reported INFANT-specific surveys/questionnaires used in previous INFANT trials.
Timepoint [3] 379221 0
12 and 18 months of age
Secondary outcome [4] 382458 0
Proportion of mothers with any breastfeeding, assessed using parent/caregiver reported INFANT-specific surveys/questionnaires used in previous INFANT trials.
Timepoint [4] 382458 0
12 months of age
Secondary outcome [5] 382459 0
Child lifestyle pattern score ‘Fruit, vegetables and outdoor time’ (a composite measure of child diet, physical activity and screen time), assessed using parent/caregiver reported surveys/questionnaires.

Lifestyle patterns scores have been derived from previous INFANT trials:
Lioret S, Campbell KJ, McNaughton SA, Cameron AJ, Salmon J, Abbott G, Hesketh KD: Lifestyle patterns begin in early childhood, persist and are socioeconomically patterned, confirming the importance of early life interventions. Nutrients 2020, 12(3).
Timepoint [5] 382459 0
12 and 18 months of age
Secondary outcome [6] 382460 0
Child lifestyle pattern score ‘Discretionary food and screen time’ (a composite measure of child diet, physical activity and screen time), assessed using parent/caregiver reported surveys/questionnaires.

Lifestyle patterns scores have been derived from previous INFANT trials:
Lioret S, Campbell KJ, McNaughton SA, Cameron AJ, Salmon J, Abbott G, Hesketh KD: Lifestyle patterns begin in early childhood, persist and are socioeconomically patterned, confirming the importance of early life interventions. Nutrients 2020, 12(3).
Timepoint [6] 382460 0
12 months of age
Secondary outcome [7] 382461 0
Change in child BMIz score, derived from parent/caregiver reported measures of child height and weight, and data linkage to health records.
Timepoint [7] 382461 0
12 and 18 months of age

Eligibility
Key inclusion criteria
To be eligible to participate in the research data collection, caregivers must meet the following criteria:
- first-time parent/primary caregiver
- infant aged 0-3 months
- infant gestation 37 weeks or greater
- parent/primary carer has a personal mobile phone
- parent/primary carer is able to communicate in English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents or primary caregivers will not be eligible to participate if the infant is not their first child, if the infant is older than 3 months or born less than 37 weeks gestation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This trial will involve comparing primary and secondary outcomes between a sample of participants receiving usual Maternal and Child Health (MCH) care (comparison group) and a sample of participants receiving usual MCH care and INFANT (intervention group) from Victoria, Australia.

Comparison participants will be recruited prior to INFANT implementation from local government areas who have expressed interest in running INFANT. If we are unable to reach our sample size from these LGAs, recruitment will be extended to other LGAs ensuring a mix of metro, regional and regional LGAs and various levels of socioeconomic disadvantage. We will allow a 3-month gap between recruitment of the last comparison participant and the commencement of INFANT implementation and recruitment of intervention participants. This gap ensures comparison participant infants will be too old to enrol in INFANT sessions and thus reduce contamination.

This trial design is appropriate for assessing program effectiveness in real-world conditions, enabling natural dissemination and program uptake to be captured.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size and power considerations
Target sample size is 1,500 infants in each arm (total 3,000) and assumes an attrition rate of 33% thus resulting in a final sample of 2,000 infants (1,000/arm). This conservative estimate of attrition is informed by our original RCT which had a 15% attrition rate over 18 months. The statistical software PASS version 14.0.9 (NCSS, LLC) has been used for all calculations. Input was obtained from the Infant and Infant Extend studies where two measurement times (9 and 18 months of age) were available. Calculations are based on outcomes measured at 18 months; clustered observations, assuming that 190 groups will run in each arm with an average number of 5.4 children with complete data per group and a coefficient of variability in group size of 0.32, as observed in the Infant RCT (a=0.05; two-sided tests). The minimum detectable differences reported below are conservative, i.e. possibly larger than the true detectable differences, because in the comparison arm clustering will be weaker.

Minimum detectable differences: Primary outcome: The target sample size (~1,000 infants per arm) achieves 80% power to detect a mean difference between arms of at least 0.17 points in the lifestyle score ‘Discretionary food and screen time’ at 18 months [standard deviation within clusters (SD) =1.21, intracluster correlation coefficient (ICC) = 0.048]. In our former INFANT trial the difference in “Discretionary food and screen time” pattern was 0.29 (95% CI: 0.08, 0.49). Secondary outcomes: The target sample size (1,000 infants per arm) achieves 80% power to detect a) a 6.2% increase in the proportion of mothers with any breastfeeding at 12 months assuming the proportion in the control group will be 27% (ICC =0.05). b) Change in energy-balance behaviours at 12 and 18 months. The target sample size has 80% power of detecting a mean difference (at 18m) between study arms of: 1) 0.24 serve/day in fruit [SD=1.7, ICC=0.071]; 2) 0.25 serve/day in vegetables [SD=2.0, ICC=0.000]; 3) 0.06 serve/day in non-core drinks [SD=0.44, ICC=0.034]; 4) 0.06 serve/day in non-core sweet [SD=0.39, ICC=0.064]; 5) 0.05 serve/day in non-core savoury [SD=0.33, ICC=0.047]; 6) 6.7 min/day of screen use [SD=44, ICC=0.11]; and 7) 18.4 min/day of physical activity [SD=143, ICC=0.018]. While individual energy-balance behaviour changes appear small, modest increments in energy consumption (126-189kJ/day (30-45 calories)) are estimated to promote population weight gain over time. Collectively these changes have capacity to influence weight gain trajectories at a population level [38, 39]. c) A mean difference between arms of at least 0.13 change in BMIz score [SD=1.0, ICC= 0.021]. Assuming a mean BMIz of 0.41, a 0.13 reduction in BMIz to 0.28 equates to a 1.3% reduction in prevalence of overweight and obesity, considered meaningful at a population level.

Statistical analysis plan
Baseline characteristics will be compared between arms using linear mixed models (LMM) or generalized estimating equation(GEE) with link and distribution selected based on the type of variable. The effect of the intervention on the primary outcome (‘Discretionary food and screen time’) will be estimated using a LMM including arm, time (12 and 18 months), interaction arm-time and any baseline variable showing clear imbalance between arms (confounders) as fixed effects. The same LMM model will be used for numerical secondary outcomes. All mixed models will include MCH group as a random effect to account for clustering. The effect of the intervention on proportion of mothers with any breastfeeding at 12 months will be estimated using a GEE model with logit link and binary distribution including arm, time (12 and 18 months), interaction arm-time and baseline counfounders.


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 in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28947 0
3000 - Melbourne
Recruitment postcode(s) [2] 28949 0
3220 - Geelong
Recruitment postcode(s) [3] 28950 0
3305 - Portland
Recruitment postcode(s) [4] 28951 0
3805 - Narre Warren
Recruitment postcode(s) [5] 28952 0
3011 - Footscray
Recruitment postcode(s) [6] 28953 0
3840 - Morwell
Recruitment postcode(s) [7] 28954 0
3067 - Abbotsford
Recruitment postcode(s) [8] 28955 0
3658 - Broadford
Recruitment postcode(s) [9] 28956 0
3191 - Sandringham

Funding & Sponsors
Funding source category [1] 304620 0
Government body
Name [1] 304620 0
National Health and Medical Research Council
Address [1] 304620 0
GPO Box 1421, Canberra ACT 2601
Country [1] 304620 0
Australia
Funding source category [2] 304623 0
Charities/Societies/Foundations
Name [2] 304623 0
Vic Health
Address [2] 304623 0
Ground Floor 15–31 Pelham St, Carlton, VIC 3053
Country [2] 304623 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Geelong Waurn Ponds campus, 75 Pigdons Road, Waurn Ponds VIC 3216
Country
Australia
Secondary sponsor category [1] 306206 0
None
Name [1] 306206 0
Address [1] 306206 0
Country [1] 306206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305041 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 305041 0
Human Research Ethics Office, Deakin University, 221 Burwood Hwy, Burwood, VIC 3125
Ethics committee country [1] 305041 0
Australia
Date submitted for ethics approval [1] 305041 0
14/10/2019
Approval date [1] 305041 0
15/11/2019
Ethics approval number [1] 305041 0
2019-403

Summary
Brief summary
This trial is part of the real-world implementation of INFANT. INFANT is an established, efficacious group-based program offered to parents and caregivers of infants, generally through Maternal and Child Health (MCH), community health, and other existing service structures. INFANT aims to improve parents’ and caregivers’ knowledge and skills around promoting healthy eating, active play, and limiting screen time and, in turn, healthy growth from the start of life. A trained health professional runs four face-to-face sessions from child age 3-12 months focusing on healthy infant feeding, active play and sedentary time. This is complemented by the My Baby Now app/website resource for parents/caregivers .

From 2020, regions across Victoria will have the opportunity to deliver INFANT as part of their usual service. Regions will receive implementation guidance to support them in embedding INFANT into routine service delivery. The research component of this project will investigate the effectiveness of the program at-scale and to do this we will collect data from caregivers receiving usual care and data from caregivers receiving usual case plus INFANT (this trial). We will also be investigating what helps organisations within LGAs to adopt and deliver the program, how they embed this in their service and whether the program is cost-effective.

This project is internationally unique and will give significant insight into how best to take a controlled research trial and translate it into the real world, into existing state-wide services.
Trial website
www.infantprogram.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99074 0
Prof Karen Campbell
Address 99074 0
Deakin University, Geelong Waurn Ponds campus, 75 Pigdons Road, Waurn Ponds VIC 3216
Country 99074 0
Australia
Phone 99074 0
+61 3 522 78414
Fax 99074 0
Email 99074 0
karen.campbell@deakin.edu.au
Contact person for public queries
Name 99075 0
Ms Sarah Marshall
Address 99075 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 99075 0
Australia
Phone 99075 0
+61 3 5227 3541
Fax 99075 0
Email 99075 0
s.marshall@deakin.edu.au
Contact person for scientific queries
Name 99076 0
Prof Karen Campbell
Address 99076 0
Deakin University, Geelong Waurn Ponds campus, 75 Pigdons Road, Waurn Ponds VIC 3216
Country 99076 0
Australia
Phone 99076 0
+61 3 522 78414
Fax 99076 0
Email 99076 0
karen.campbell@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified outcome data.
When will data be available (start and end dates)?
The data will be available after Dec 2024. No end date specified.
Available to whom?
Data may be made available upon request with a methodologically sound proposal and with ethics approval.
Available for what types of analyses?
Meta-analyses.
How or where can data be obtained?
Via emailing the Principal Investigator - Professor Karen Campbell, Deakin University karen.campbell@deakin.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results