Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000605695
Ethics application status
Approved
Date submitted
29/05/2014
Date registered
6/06/2014
Date last updated
5/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Parent Infant Feeding Initiative: a study to enhance breastfeeding duration
Scientific title
Parent Infant Feeding Initiative: A randomised controlled trial involving fathers and mothers to enhance breastfeeding duration with two medium level intervention groups, one high level intervention group and a control group receiving usual care.
Secondary ID [1] 284690 0
Nil
Universal Trial Number (UTN)
U1111-1155-7115
Trial acronym
PIFI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breastfeeding duration 292044 0
Condition category
Condition code
Public Health 292380 292380 0 0
Health promotion/education
Reproductive Health and Childbirth 292423 292423 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three (3) interventions - two medium level and one high level. Medium intervention 1 will consist of an additional specialised 1 hour antenatal education session delivered to the fathers when the mother is at least 32 weks gestation. The session content will focus on fatherhood and the positive role of fathers in relation to breastfeeding support, the importance/benefits of breast feeding to infants and mothers and anticipatory problem solving (eg. for breastfeeding issues like engorgement and mastitis). Infant developmental milestones and postnatal depression will also be specifically included. In addition, fathers will receive associated take-home educational print material for both parents to support the anticipatory problem solvoing and decision making component of the session. For medium intervention 2, the content will be similar to that for medium intervention 1 but it will be delivered sequentially with information relevant to the infant developmental milestones at the time. Material will be delivered to the father via the internet and mobile phone technology on a weekly basis for the first 6 weeks after birth and then every two weeks from 6-26 weeks or until breastfeeding stops, if earlier than 26 weeks. Materials will include goal setting exercises and short quizzes. Links to web-based materials will be provided, which participants will access using a unique log-in. High intervention comprises medium intervention 1 and medium intervention 2 combined (ie specialised antenatal class and social support).

Process evaluation at the end of the intervention will determine participant self-reported use and acceptance of materials with questions included in the final questionnaire. Participation in phone app exercises and visits to web-pages can also be monitored at the participant level.
Intervention code [1] 289480 0
Behaviour
Comparator / control treatment
The control group will have access to the usual care (standard antenatal education classes and postnatal services) provided by the hospital.
Control group
Active

Outcomes
Primary outcome [1] 292239 0
Duration of any breastfeeding
Timepoint [1] 292239 0
At six and 26 weeks after birth participants will self-report by telephone follow-up call or self-completion of an online questionnaire, designed specifically for this study.
Primary outcome [2] 292240 0
Duration of exclusive breastfeeding
Timepoint [2] 292240 0
At six and 26 weeks after birth participants will self-report by telephone follow-up call or self-completion of an online questionnaire, designed specifically for this study.
Secondary outcome [1] 308517 0
Age of introduction of formula
Timepoint [1] 308517 0
At six and 26 weeks after birth participants will self-report by telephone follow-up call or self-completion of an online questionnaire, designed specifically for this study.
Secondary outcome [2] 308529 0
Age of introduction of complementary foods (‘solids’)
Timepoint [2] 308529 0
At six and 26 weeks after birth participants will self-report by telephone follow-up call or self-completion of an online questionnaire, designed specifically for this study.
Secondary outcome [3] 308531 0
Maternal breastfeeding self-efficacy
Timepoint [3] 308531 0
At six and 26 weks after birth. Breastfeeding self-efficacy will be measured using the widely used short Breastfeeding self-efficacy scale developed and validated by Dennis and Faux. Dennis CL, Faux S: Development and psychometric testing of the Breastfeeding Self-Efficacy Scale. Research in nursing & health 1999, 22(5):399-409.
Secondary outcome [4] 308538 0
Infant feeding attitudes of both partners.
Timepoint [4] 308538 0
At six and 26 weeks after birth. Measured using the widely used Iowa Infant Feeding Attitude Scale developed and validated by de la Mora et al (de la Mora A, Russell DW, Dungy CI, Losch M, Dusdieker L: The Iowa Infant Feeding Attitude Scale: Analysis of reliability and validity. Journal of Applied Social Psychology 1999, 29(11):2362-2380) and subsequently validated and used by the researchers for use with fathers Scott J, Shaker I, Reid M: Parental attitudes toward breastfeeding: Their association with feeding outcome at hospital discharge. Birth 2004, 31(2):125-131.
Secondary outcome [5] 308631 0
Cost-effectiveness
Timepoint [5] 308631 0
Following conclusion of the study. This study will undertake a cost- consequences analysis conducted from the perspective of the health service. The economic analysis will compare the incremental costs of the PIFI intervention (difference in costs accrued in the control arm, compared to those in the intervention arms) with those of the incremental primary outcomes, all expressed in their natural units of measurement (e.g. weeks of breastfeeding). We will also attempt to provide cost-effectiveness data on longer term outcomes associated with breastfeeding, using existing WA epidemiological data and evidence from the literature to explore and model the linkage between breastfeeding incidence and duration and longer term health outcomes. Sensitivity analysis will be used to explore the uncertainty in the cost and outcome data. The study will also conduct a discrete choice experiment to explore participants’ perspectives of the PIFI initiative which will be used to elicit information on the benefits of the intervention. This aspect will allow for the exploration of individuals’ preferences for each of the alternative levels of intervention (i.e. control, medium intervention 1, medium intervention 2 and the high intervention). Discrete choice experiments are increasingly being used in economic analysis to measure the benefits associated with health care interventions

Eligibility
Key inclusion criteria
For couples to be eligible to participate they must own a ‘Smart’ phone and have internet access, reside within WA, both partners must intend to participate in the rearing of their child and there are no existing medical conditions in the mother that are likely to inhibit the initiation of breastfeeding or exclusive breastfeeding.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Couples don't own a ‘Smart’ phone nor have internet access, don't reside within WA, both partners don't intend to participate in the rearing of their child, couples are same sex and there are existing medical conditions in the mother that are likely to inhibit the initiation of breastfeeding or exclusive breastfeeding.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Fathers and their partners enrolling in the hospital-delivered antenatal classes will be randomised, with a random number generator with no blinding, to either a control or one of the intervention groups in each hospital prior to their first attendance at their antenatal classes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be determined through a computer-based random sequence generator (simple randomisation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Factorial
Other design features
This is a four-armed parallel randomised controlled trial. There is a control group, 2 medium level intervention groups and 1 high level intervention group (combination of two medium interventions).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
The key outcome variable for statistical analysis is duration of breastfeeding. It is assumed that at 26 weeks, there is at least a 10% difference in the proportion of mothers’ breastfeeding between any two of the groups. A sample size of 300 subjects (fathers) is required in each of the 3 intervention groups and control group to be able to detect the difference at 80% power and 5% level of significance, using a Log-rank survival test. Assuming a loss to follow-up of 25% in each group, a total of 400 for each group will be recruited (Total n recruited = 1600 fathers, total n required =1200). The sample size calculations were calculated in terms of the hazard ratio taking into account the censoring of data, as required since survival analysis will be used for the analysis of the main outcome variable – time to breastfeeding cessation.

Data Analyses
After data are cleaned, the missing values analysis procedure in SPSS Version 22 will be used to: describe the pattern of missing data; estimate means, standard deviations, covariance and correlations for different missing value methods; and impute the missing values with estimated means from regression or expectation minimization methods.

Multivariable survival and logistic regression analyses will be used to assess the effect of the treatment groups on the outcome after adjusting for covariates. The study has a factorial treatment structure comparing Antenatal Education (Yes, No) and Social Support (Yes, No). In addition to testing the main effects, this factorial treatment structure will allow the testing of the interaction between any two factors. It is hypothesised that the combined effect of both interventions will be significantly greater than the effect of either intervention in isolation. The main effects of Antenatal Education and Social Support together with all the interactions between these factors will be assessed in the analyses of the data. Survival analysis will be used to examine the effects of the various treatment groups on the duration of any and exclusive breastfeeding. A similar analysis will be performed for introduction of infant formula and complementary food. This type of analysis allows for the presence of censored data. ‘Censored data’ refers to those cases where breastfeeding continues beyond the end of the study period or beyond the time at which the subject dropped out of the study. Variables reported in the literature to be associated with duration of overall breastfeeding and age of introduction of complementary foods will be investigated using Cox’s proportional hazards model. This model allows joint estimation of the effects of predictor variables on the ‘hazard’ – the risk of cessation of breastfeeding / complementary food introduction. Possible covariates that will be considered in the Survival analysis will include amongst others: socio-demographic factors such as maternal age, level of education and return to work; biomedical factors such as parity, maternal smoking and weight status; and psychosocial factors such as infant feeding attitudes and breastfeeding self-efficacy.

Cost and cost effectiveness analysis
The study will undertake a costs analysis from the perspective of the health service and will develop an economic model to estimate the cost-effectiveness of the PIFI intervention. Costs will include direct costs associated with the program including set up costs and cost of delivering activities. In terms of outcome measurement we will include short-term outcomes that look at the cost per additional women breastfeeding and cost per percentage change in breastfeeding . We will also attempt to provide cost-effectiveness data on longer term outcomes associated with breastfeeding using existing WA epidemiological data and evidence from the literature to explore and model the linkage between breastfeeding incidence and health outcomes. Relevant data from this aspect of the study will then be included in our economic model and used to explore the cost-effectiveness of the PIFI intervention.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2015
Actual
1/08/2015
Date of last participant enrolment
Anticipated
31/12/2016
Actual
22/12/2016
Date of last data collection
Anticipated
31/08/2017
Actual
Sample size
Target
1600
Accrual to date
Final
1426
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4841 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [2] 4842 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [3] 4843 0
Osborne Park Hospital - Stirling
Recruitment hospital [4] 4844 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [5] 4846 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [6] 5854 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [7] 5954 0
St John of God Midland Public Hospital - Midland
Recruitment hospital [8] 6263 0
St John of God Hospital, Mt Lawtley - Mt Lawley
Recruitment postcode(s) [1] 13699 0
6050 - Mt Lawley

Funding & Sponsors
Funding source category [1] 289321 0
Government body
Name [1] 289321 0
Healthway
Country [1] 289321 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
PERTH WA 6845
Country
Australia
Secondary sponsor category [1] 287991 0
None
Name [1] 287991 0
Address [1] 287991 0
Country [1] 287991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291083 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291083 0
Ethics committee country [1] 291083 0
Australia
Date submitted for ethics approval [1] 291083 0
Approval date [1] 291083 0
15/05/2014
Ethics approval number [1] 291083 0
HR 82/2014
Ethics committee name [2] 293978 0
Sir Charles Gairdner Group
Ethics committee address [2] 293978 0
Ethics committee country [2] 293978 0
Australia
Date submitted for ethics approval [2] 293978 0
Approval date [2] 293978 0
20/11/2014
Ethics approval number [2] 293978 0
2014-111
Ethics committee name [3] 293979 0
St John of God Health Care
Ethics committee address [3] 293979 0
Ethics committee country [3] 293979 0
Australia
Date submitted for ethics approval [3] 293979 0
Approval date [3] 293979 0
08/04/2015
Ethics approval number [3] 293979 0
777
Ethics committee name [4] 295127 0
Women and Newborn Health Service HREC
Ethics committee address [4] 295127 0
Ethics committee country [4] 295127 0
Australia
Date submitted for ethics approval [4] 295127 0
Approval date [4] 295127 0
04/05/2016
Ethics approval number [4] 295127 0
2016037EW

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 61 61 0 0
/AnzctrAttachments/366435-PIFI Ethics HR82_2014.pdf
Attachments [2] 660 660 0 0
/AnzctrAttachments/366435-SJGH Ethics approval.pdf
Attachments [3] 661 661 0 0
/AnzctrAttachments/366435-2014-111 SCGG HREC Approval.pdf

Contacts
Principal investigator
Name 48798 0
Prof Jane Scott
Address 48798 0
School of Public Health
Curtin University
GPO Box U1987
PERTH WA 6845
Country 48798 0
Australia
Phone 48798 0
+61 8 9266 9050
Fax 48798 0
+61 8 9266 2958
Email 48798 0
[email protected]
Contact person for public queries
Name 48799 0
Anita Jorgensen
Address 48799 0
School of Public Health
Curtin University
GPO Box U1987
PERTH WA 6845
Country 48799 0
Australia
Phone 48799 0
+61 8 9226 2291
Fax 48799 0
+61 8 9266 2958
Email 48799 0
[email protected]
Contact person for scientific queries
Name 48800 0
Jane Scott
Address 48800 0
School of Public Health
Curtin University
GPO Box U1987
PERTH WA 6845
Country 48800 0
Australia
Phone 48800 0
+61 8 9266 9050
Fax 48800 0
+61 8 9266 2958
Email 48800 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA study to prolong breastfeeding duration: Design and rationale of the Parent Infant Feeding Initiative (PIFI) randomised controlled trial.2015https://dx.doi.org/10.1186/s12884-015-0601-5
EmbaseSupport for healthy breastfeeding mothers with healthy term babies.2017https://dx.doi.org/10.1002/14651858.CD001141.pub5
N.B. These documents automatically identified may not have been verified by the study sponsor.