Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000648628
Ethics application status
Approved
Date submitted
10/03/2023
Date registered
15/06/2023
Date last updated
15/06/2023
Date data sharing statement initially provided
15/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Structured breastfeeding support for healthcare professionals and parents

Scientific title
Investigating the effect of a structured breastfeeding support program for healthcare professionals and parents breastfeeding practices
Secondary ID [1] 309173 0
Funder: Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden.
Secondary ID:: 273762
Universal Trial Number (UTN)
Trial acronym
SIAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reproductive health and childbirth 329617 0
Breast feeding 329618 0
Condition category
Condition code
Reproductive Health and Childbirth 326252 326252 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aiming to develop and implement a complex intervention with appropriate evidence-based support strategies, to help mothers reach their breastfeeding goals. The project aims to review evidence-based breastfeeding practice in line with the Ten Steps to Successful Breastfeeding and WHO recommendations about breastfeeding. This implement research involve both quantitative and qualitative data.

Setting: The healthcare service in the region includes 15 antenatal clinics, 2 hospitals with breastfeeding outpatient clinics, and 26 child health centres. Antenatal care provided by midwives includes approximately 8–10 visits during pregnancy, a follow-up contact by telephone 7–10 days postpartum, and an antenatal care visit 8–12 weeks after delivery. Parents often see a child healthcare nurse at the child health centre 1-2 weeks postpartum. The infant’s first year includes approximately 12–13 visits to a child healthcare nurse and 3 visits to a physician.

All 15 antenatal clinics in the region had participated in a project aiming to provide safe and equal care, individually adapted to the family’s postpartum needs, with input from mothers regarding the design of care and evaluation of the project. The intervention was developed based on the results from this project. All 15 antenatal clinics in the region were invited to participate. First six antenatal clinics were non-randomly selected to constitute the intervention group of practical reasons, while the remaining nine clinics served as the control group. The intervention as well as the control group cared for about 1,650 women/year. After being informed about the breastfeeding project and the possibility to participate, all 15 antenatal clinics agreed to take part in the project.

Thereafter all 26 child healthcentres in the region were invited to participate in the breastfeeding project. The 11 child health centres with regular contact with the 6 antenatal clinics in the intervention group were invited to participate in the intervention group. Meanwhile, the 15 child health centres in regular contact with the nine antenatal clinics in the control group were invited to participate in the control group. Healthcare professionals in the control group were informed that they would receive the same breastfeeding training programme after the study was completed. After being informed about the project and the possibility to participate, eight of the 11 child health centres in the intervention group and nine of the 15 child health centres in the control group agreed to take part in the project. Among the reasons given for non-participation were “engaged in other projects” and “being short-staffed”.

Intervention: Midwives working at the antenatal care centres and child healthcare nurses at the child health centre in the intervention group participated in a breastfeeding training program in line with the Ten Steps to Successful Breastfeeding and WHO recommendations about breastfeeding. The training program involved two phases:
1. Phase one:
a. Online breastfeeding education (3.0 hours). The intervention group received an email with a web-link to 13 short online lectures before an inter-professional training day: Breastfeeding and professional support, Breastfeeding and health, Breastfeeding and self-efficacy, The very first breastfeeding session, Breastfeeding, skin to skin contact, and kangaroo mother care, Attachment, skin-to-skin contact, and breastfeeding, Expressing milk by hand, pumping and supplementation, How to prevent breastfeeding problems, Breastfeeding recommendations and the WHO code, Breastfeeding and complementary feeding, Breastfeeding patterns, Breastfeeding and growth, Breastfeeding, sleep and infant crying
b. Participants should also reflect about three questions before the training day (1.0 hours):
i. Personal experiences of and attitudes to breastfeeding,
ii. Evidence-based professional breastfeeding support, and
iii. What changes they would like to introduce at their workplace to make it easier for mothers to breastfeed.
2. Phase two: An inter-professional training day (8.5 hours, face-to-face). Healthcare professionals worked with their personal experiences and attitudes towards breastfeeding. They trained to offer and provide evidence-based support guided by material and the breastfeeding plan to parents in the intervention group. They trained to listen to the family and ask open-ended questions in the dialogue. The training day also included small group discussions on breastfeeding case scenarios.

All three persons responsible for the training day worked in the healthcare region. One was responsible for the development of care at the antenatal clinics, one was head of the antenatal clinic, and one was care developer at the child health centre. All three were experienced breastfeeding trainers and counsellors and had personal experiences of breastfeeding.

Data collection for healthcare professionals started July 2020. After the training healthcare professionals at the intervention site received their training program, recruitment start for parents at the intervention sites as well as at the control sites.

The breastfeeding support programme in the intervention group is described below.

Women visit both antenatal care and child health centre.
1. Antenatal care (one-on-one session):
a. Pregnant women received structured breastfeeding counselling during normal face to face visits at pregnancy weeks 28, 32 and 38 (5–10 min).
b. An individual breastfeeding plan was established in cooperation with the parents-to-be by pregnancy week 32. The plan included:
1) Self-studies during pregnancy,
2) QR-codes for four short online breastfeeding lectures, and
3) QR-codes for two leaflets.
c. The midwife followed up on the breastfeeding plan face to face during the normal visit 8–12 weeks postpartum.
2. Child health centre (one-on-one session) (post-natal care):
a. Parents received structured breastfeeding counselling face to face during the normal visits at two and six weeks, as well as three and five months postpartum (5–10 min).
b. The child healthcare nurse followed up on the breastfeeding plan face to face at each visit.

Structed breastfeeding counselling provided for both antenatal care and child health centre visits: The evidence-based picture and conversation material used by midwives during antenatal care and child healthcare nurses at the child health centre: Healthcare professionals used empathetic, reflective listening with open-ended questions, reflected and summarised. Healthcare professionals explore what the breastfeeding family already knows about breastfeeding, ask for permission to provide information and offer information.

-Antenatal care: During pregnancy the midwife talk about: Health benefits for mother and baby, Skin-to-skin contact and breastfeeding for the first time, How to tell when your baby wants to feed, and that breastfeeding is working. After birth they followed up women’s intentions, parents' experiences and expectations and what kind of breastfeeding support they want from their family and healthcare professionals. If mothers need more breastfeeding support, professionals should help them to contact the breastfeeding outpatient clinic.

-Child health centre: After birth the child healthcare nurse talk about: Sleep-deprived, Development phases, Breastfeeding for the first 6 months and Breastfeeding when your baby starts tasting solid food. They also followed up women’s intentions, parents' experiences and expectations and what kind of breastfeeding support they want from their family and healthcare professionals. If mothers need more breastfeeding support, professionals should help them to contact the breastfeeding outpatient clinic.

Standard education to healthcare professionals in the region: All healthcare professionals working in the region are normally invited to participate in a voluntary breastfeeding education course (3 hours) every year, with various themes. The course may, e.g. cover health benefits of breastfeeding or breastfeeding problems.

Standard care women: The midwife at antenatal care talked about breastfeeding, and women received a leaflet during the visit in pregnancy week 28.

Midwives in the intervention and control group requit parents for the qualitative evaluation. The midwives and later the child healthcare nurse filled in a checklist for these women of their attendance and if parents used the program.

Heads of the clinics and healthcare professionals at the antenatal clinics and child healthcare centres in the region receive verbal information about the study and the possibility of participating. Healthcare professionals working at the clinics that want to participate receive a mail with written information about the study. They were informed about the voluntary nature of participation and told that they could terminate their participation at any time. All healthcare professionals working at the clinics that want to participate in the intervention group receive the training program.

All parents receive information about the study and were given an opportunity to ask questions. They were informed about the voluntary nature of participation and told that they could terminate their participation at any time.

Intervention code [1] 325620 0
Behaviour
Intervention code [2] 325621 0
Lifestyle
Comparator / control treatment
Standard care in the control group healthcare professionals: All healthcare professionals working in the region are invited to participate in a voluntary breastfeeding education course face to face (3 hours) every year, with differing themes. The course may, e.g., cover health benefits of breastfeeding or breastfeeding problems. Healthcare professionals in the control group did not work together with HCPs in the intervention group.

Standard care in the control group: The midwife at antenatal care talked about breastfeeding, and women received a leaflet during the visit in pregnancy week 28.
Control group
Active

Outcomes
Primary outcome [1] 334122 0
Breastfeeding

Questionnaire: Breastfeeding and Infant Feeding Practices,

Timepoint [1] 334122 0
One, two, four, six, twelve and twenty four months after birth.
Secondary outcome [1] 419420 0
Does the implementation program affect the parents' responsiveness to the
infant?

Questionnaires to parents: Baby Care Questionnaire (BCQ),
Timepoint [1] 419420 0
Two months after birth.
Secondary outcome [2] 419421 0
Does the implementation program affect healthcare professionals perceptions of breastfeeding?

Questionnaires: Breastfeeding Support Confidence Scale (BSCS) designed specifically for this study.
Timepoint [2] 419421 0
Before the training. At the end of their inter-professional training day and one year after the training day.
Secondary outcome [3] 421838 0
Does the implementation program affect healthcare professionals experiences of providing breastfeeding support?

Eight fokusgroups with healthcare professionals. A interview guide with semi-structured questions designed specifically for this study. will be presented to focus groups of up to 6-8 healthcare professionals and one researcher, The responses will be audio-recorded for later analysis,

Timepoint [3] 421838 0
Focusgroups after the the traning program.
Secondary outcome [4] 421841 0
Does the implementation program affect the parents' confidence in breastfeeding?

Questionnaires: Breastfeeding Self Efficacy Scale- Short Form (BSES-SF).
Timepoint [4] 421841 0
During pregnancy and 2 months after the infant’s birth.
Secondary outcome [5] 422299 0
Does the implementation program affect the parents' responsiveness to the
infant?

Questionnaires to parents: Edinburgh Postnatal Depression,
Timepoint [5] 422299 0
During pregancy and two months after birth.
Secondary outcome [6] 422300 0
Does the implementation program affect healthcare professionals perceptions of breastfeeding?

Questionnaires: Attitude scale designed specifically for this study.
Timepoint [6] 422300 0
Before the training. At the end of their inter-professional training day and one year after the training day.
Secondary outcome [7] 422301 0
Does the implementation program affect the parents' experience in breastfeeding?

Questionnaires: Breastfeeding Emotional Scale,

Timepoint [7] 422301 0
Two and 12 months after the infant’s birth.
Secondary outcome [8] 422302 0
Does the implementation program affect the parents' experience in breastfeeding?

Questionnaires: Breastfeeding Physical Pain Scale,
Timepoint [8] 422302 0
Two and 12 months after the infant’s birth.
Secondary outcome [9] 422305 0
Does the implementation program affect the parents' experience in breastfeeding?

Diaries and telephone interviews with an semi-structured questions designed specifically for this study, by one researcher, The responses will be audio-recorded for later analysis,
Timepoint [9] 422305 0
During pregnancy 2, 4, 6 and 12 months after the infant’s birth.

Eligibility
Key inclusion criteria
The inclusion criteria for parents’ were that women were healthy and, at pregnancy
week 24, planned to initiate breastfeeding after birth. Another criterion was that the parents’ could communicate in Swedish.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Asylum-seeking women. Women under the age of 18. Mothers of children with chromosomal abnormality or major malformation (e.g. cleft lip, jaw, palate), Growth retardation ("small for gestational age"), and need for care in the neonatal ward. Women with diabetes and with ongoing substance abuse. Women with serious mental illness (psychosis, bipolar disorder, major depression that required hospitalization or ECT treatment) or developmental disability.

Study design
Purpose of the study
Educational / counselling / training
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
Parallel
Other design features
Implementation research
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
6/11/2023
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
800
Accrual to date
600
Final
Recruitment outside Australia
Country [1] 25312 0
Sweden
State/province [1] 25312 0
Region Sörmland

Funding & Sponsors
Funding source category [1] 313371 0
University
Name [1] 313371 0
Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden
Country [1] 313371 0
Sweden
Primary sponsor type
University
Name
Uppsala university
Address
Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden
Dag Hammarskjölds väg 14 B
752 37 Uppsala
Sweden
Country
Sweden
Secondary sponsor category [1] 315131 0
University
Name [1] 315131 0
Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden
Address [1] 315131 0
Centrum för klinisk forskning Region Sörmland
Sveavägen entré 9, våning 5 (Mälarsjukhuset)
631 88 Eskilstuna
Country [1] 315131 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312588 0
Etikprövningsmyndigheten
Ethics committee address [1] 312588 0
Ethics committee country [1] 312588 0
Sweden
Date submitted for ethics approval [1] 312588 0
Approval date [1] 312588 0
11/05/2020
Ethics approval number [1] 312588 0
2020-01425

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

Contacts
Principal investigator
Name 125198 0
A/Prof Eva-Lotta Funkquist
Address 125198 0
Department of Women’s and Children’s Health, Uppsala University
MTC-huset, Dag Hammarskjölds väg 14B, 1 tr
752 37 Uppsala
Sweden
Country 125198 0
Sweden
Phone 125198 0
+46730306201
Fax 125198 0
Email 125198 0
[email protected]
Contact person for public queries
Name 125199 0
Eva-Lotta Funkquist
Address 125199 0
Department of Women’s and Children’s Health, Uppsala University
MTC-huset, Dag Hammarskjölds väg 14B, 1 tr
752 37 Uppsala
Sweden
Country 125199 0
Sweden
Phone 125199 0
+46730306201
Fax 125199 0
+46730306201
Email 125199 0
[email protected]
Contact person for scientific queries
Name 125200 0
Eva-Lotta Funkquist
Address 125200 0
Department of Women’s and Children’s Health, Uppsala University
MTC-huset, Dag Hammarskjölds väg 14B, 1 tr
752 37 Uppsala
Sweden
Country 125200 0
Sweden
Phone 125200 0
+46730306201
Fax 125200 0
Email 125200 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
Individual patient data will not be shared publicly. Aggregate patient data and final results will be presented in articles


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
No additional documents have been identified.