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Real-world implementation, effectiveness and cost-effectiveness of INFANT: an evidence-based program addressing lifestyle behaviours from the start of life

Real-world implementation, effectiveness and cost-effectiveness of the Infant Feeding, Activity and Nutrition (INFANT) Program

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000670976
Acronym
Large-scale INFANT
Enrollment
3000
Registered
2020-06-12
Start date
2020-07-01
Completion date
2022-02-01
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 INFAN

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.

Sponsors

Deakin University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026