Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001024831
Ethics application status
Approved
Date submitted
21/09/2012
Date registered
24/09/2012
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Date results provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Ringing Up about Breastfeeding: a randomised control trial exploring earlY telephone peer support for breastfeeding.
Scientific title
Does providing first time mothers (who are planning to breastfeed) with telephone peer support from volunteer mothers (compared with usual care) increase the proportion feeding their infant any breast milk at six months postpartum
Secondary ID [1] 281289 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
RUBY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 287219 0
Condition category
Condition code
Public Health 287819 287819 0 0
Health promotion/education
Reproductive Health and Childbirth 287823 287823 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Proactive telephone support provided by another mother with breastfeeding experience, in the early postnatal period i.e. weekly calls of varying duration (dependent upon need)for up to 12 weeks after birth. the volunteer mother providing support will have have had some training provided by the Australian Breastfeeding Association and be provided with ongoing support form the Peer Volunteer coordinator
Intervention code [1] 285525 0
Behaviour
Comparator / control treatment
Usual hospital care and community breastfeeding support - usually requiring women to actively seek support
Control group
Active

Outcomes
Primary outcome [1] 287786 0
Peer support provided by telephone in the postnatal period will increase the proportion of infants receiving any breast milk at six months by 10% compared with standard care(from 46% to 56%).Telephone interviews will be conducted for all participants 6 months after birth.
Timepoint [1] 287786 0
Baby six months of age
Secondary outcome [1] 298837 0
Test if telephone peer support intervention increases mean breastfeeding duration.Telephone interviews will be conducted for all participants 6 months after birth.
Timepoint [1] 298837 0
Baby six months of age
Secondary outcome [2] 298838 0
Test if telephone peer support increases exclusive breastfeeding at six months.Telephone interviews will be conducted for all participants 6 months after birth.
Timepoint [2] 298838 0
Baby six months of age
Secondary outcome [3] 298839 0
Evaluate the interventions from the participant and peer support volunteer perspectives. A telephone interview will be conducted at the conclusion of telephone support from the peer volunteer.
Peer volunteers will keep a record of contact with the breastfeeding mother and at trial completion peer volunteers will complete a short questionnaire evaluating their experience of providing support.
Timepoint [3] 298839 0
Six months
Secondary outcome [4] 298840 0
Evaluate the cost-effectiveness of peer support. The economic evaluation will first compare the incremental costs and all consequences of the intervention to the control group and then assess cost-effectiveness against any breastfeeding at six months. Data collection for economic evaluation is integrated in the process and outcome evaluation components e.g. household expenditure on infant feeding materials and equipment; health service use since discharge (e.g. admissions, GP visits, drug treatments, use of midwife/ MCHN/other sources of help and advice). Resource use detailed in activity logs will be costed using standard unit costs for telephone expenses and for time use of peers and participants. The trial team will keep detailed records of resources used in peer recruitment, training, support and coordination.
Timepoint [4] 298840 0
Six months

Eligibility
Key inclusion criteria
English speaking
Mother having her first live baby
Breastfeeding or intending to breastfeed
Singleton
Giving birth in a public hospital
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Very ill women.
Women who do not have the capacity to consent, including women who are highly dependent on medical care, and those with an intellectual or mental impairment to the extent that they could not provide informed consent.Mother of babies born prematurely or babies remaining in hospital after the mother's discharge after birth. Women with antenatal membership of the Australian Breastfeeding Association

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research midwives will recruit women to the trial in the postanatal wards of the study hospitals, at least 24hours after the birth(unless earlier discharge is planned) and prior to discharge from hospital.
The research midwife will review a computer generated list of all women who have given birth to their first baby in the previous 24hours , then approach staff in the postnatal ward to confirm eligibility.The research midwife will follow a protocal to approach women, explain the study, offer trial participation and obtain written consent. it will be made clear that women can withdraw at any time.
Allocation to an intervention or non-intervention group will be via a centralisied computer randomisation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be stratified by trial site, then randomised to one of the two trial arms. The randomisation sequence will be done using using small blocks of varying size.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Three sites
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2012
Actual
14/02/2013
Date of last participant enrolment
Anticipated
Actual
15/12/2015
Date of last data collection
Anticipated
Actual
17/08/2016
Sample size
Target
1152
Accrual to date
Final
1157
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18702 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 18703 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 18704 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 5597 0
3052
Recruitment postcode(s) [2] 5598 0
3021
Recruitment postcode(s) [3] 5599 0
3168
Recruitment postcode(s) [4] 33140 0
3052 - Parkville
Recruitment postcode(s) [5] 33141 0
3168 - Clayton
Recruitment postcode(s) [6] 33142 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 285852 0
Charities/Societies/Foundations
Name [1] 285852 0
Felton bequest
Country [1] 285852 0
Australia
Funding source category [2] 286050 0
University
Name [2] 286050 0
La Trobe University
Country [2] 286050 0
Australia
Primary sponsor type
University
Name
Mother and Child Health Research, La Trobe University
Address
215 Franklin Street
Melbourne 3000
Victoria
Country
Australia
Secondary sponsor category [1] 284675 0
Hospital
Name [1] 284675 0
The Royal Women's Hospital
Address [1] 284675 0
Corner Grattan Street and Flemington Road
Parkville 3052
Victoria
Country [1] 284675 0
Australia
Other collaborator category [1] 277031 0
Hospital
Name [1] 277031 0
Western Health :Sunshine Hospital
Address [1] 277031 0
Furlong Road
St Albans 3021
Victoria
Country [1] 277031 0
Australia
Other collaborator category [2] 277032 0
Hospital
Name [2] 277032 0
Southern Health:Monash Medical Centre
Address [2] 277032 0
246 Clayton Road
Clayton 3168
Victoria
Country [2] 277032 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288102 0
Royal Women's Hospital
Ethics committee address [1] 288102 0
Ethics committee country [1] 288102 0
Australia
Date submitted for ethics approval [1] 288102 0
Approval date [1] 288102 0
21/08/2012
Ethics approval number [1] 288102 0

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

Contacts
Principal investigator
Name 34601 0
Prof Della Forster
Address 34601 0
Judith Lumley Centre
Level 3, George Singer Building
La Trobe University
Bundoora, Victoria 3086
Country 34601 0
Australia
Phone 34601 0
+61 3 9479 8783
Fax 34601 0
Email 34601 0
[email protected]
Contact person for public queries
Name 17848 0
Fiona McLardie-Hore
Address 17848 0
Midwifery and Maternity Services Research
The Royal Womens Hospital
Locked Bag 300
Parkville 3052
Victoria
Country 17848 0
Australia
Phone 17848 0
+61 3 83452932
Fax 17848 0
Email 17848 0
[email protected]
Contact person for scientific queries
Name 8776 0
Della Forster
Address 8776 0
Mother and Child Health research
La Trobe University
215 Franklin Street
Melbourne 3000
Victoria
Country 8776 0
Australia
Phone 8776 0
+61 3 83418573
Fax 8776 0
Email 8776 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
SourceTitleYear of PublicationDOI
EmbaseProactive Peer (Mother-to-Mother) Breastfeeding Support by Telephone (Ringing up About Breastfeeding Early [RUBY]): A Multicentre, Unblinded, Randomised Controlled Trial.2019https://dx.doi.org/10.1016/j.eclinm.2019.02.003
EmbaseVolunteers' experiences of providing telephone-based breast-feeding peer support in the RUBY randomised controlled trial.2020https://dx.doi.org/10.1017/S136898002000124X
EmbaseImplementing a successful proactive telephone breastfeeding peer support intervention: volunteer recruitment, training, and intervention delivery in the RUBY randomised controlled trial.2021https://dx.doi.org/10.1186/s13006-021-00434-9
EmbaseIs proactive telephone-based breastfeeding peer support a cost-effective intervention? A within-trial cost-effectiveness analysis of the 'Ringing Up about Breastfeeding earlY' (RUBY) randomised controlled trial.2023https://dx.doi.org/10.1136/bmjopen-2022-067049
N.B. These documents automatically identified may not have been verified by the study sponsor.