Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000354987
Ethics application status
Approved
Date submitted
31/03/2011
Date registered
5/04/2011
Date last updated
5/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breastfeeding and quality of care
Scientific title
Breastfeeding and quality of care

A process oriented training intervention for health professionals
Secondary ID [1] 259894 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast feeding success 265494 0
professional support 265502 0
mothers feelings for and relation to her baby 265503 0
Condition category
Condition code
Reproductive Health and Childbirth 265645 265645 0 0
Childbirth and postnatal care
Public Health 265655 265655 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intervention was conducted through a process-oriented program on parental support and breastfeeding counseling for midwives and postnatal nurses from the antenatal and child health centers in the study area. The training program included evidence-based methods to parental support and breastfeeding counseling. The learning methods were based on lectures and collegial discussions on professional stance, reflective processes, problem-solving processes, and practical skills in relation to breastfeeding. In all seven lectures and seminars were held during the training period. Between the meetings each participant wrote a diary with personal reflections on the issues that were discussed in the lectures. The training program was carried out from September 1999 through March 2000.
Intervention code [1] 264320 0
Behaviour
Comparator / control treatment
Two control-groups and one intervention group were used in this study. Before any effects of the process-oriented training program could be detected data were collected for a baseline group called control group A (CGA, n=167). The baseline group (CGA) allowed detection of changes over time and any spillover effects of the intervention. The recruitment of the CGA mothers took place between April 2000 and October 2000 from the control sites. After the healthcare professionals at the intervention sites had received their process-oriented training program, recruitment started for mothers at the intervention sites (IG) as well as at the control sites (CGB n= 172) in a consecutive order between October 2000 and April 2003. All mothers were followed at three days, three and nine months postpartum. Datacollection from CGA and CGB only differed in time for data collection, otherwise the control group mothers belonged to the same control site.
Control group
Active

Outcomes
Primary outcome [1] 262437 0
breast feeding success
perceived professional and social support
perceived maternal feelings for and relation to her baby measured by self-reported questionnaires
Timepoint [1] 262437 0
Data collection historical control group started April 2000 and ended in October 2000.
Intervention that was a process oriented training of health care professionals in the intervention municipalities. The training program was carried out from September 1999 through March 2000.
Data collection for intervention group and simultaneous control group started in October 2000 and ended in January 2003.
It should be noted that the mothers were not aware of if they were in the intervention or in any of the control groups
Secondary outcome [1] 273779 0
nil
Timepoint [1] 273779 0
nil

Eligibility
Key inclusion criteria
Eligible participants for this study were Swedish-speaking, first-time mothers who gave birth to a singleton, healthy infant at term, and had received care from healthcare professionals at either the intervention site or the control site.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers who gave birth to children with life-threatening diseases or malformations were excluded.

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)
Allocation to intervention or control group were done at municipality level, i.e. mothers living in and cared for at intervention site health centers were allocated to intervention group and mothers living in and cared for at control site health centers were allocated to control group. The mothers were invited in the study consecutively at the maternity ward.
The midwives at the maternity ward provided information and questionnaires and they knew if the mothers were intervention or control since allocation to intervention or control was already decided based on the mothers living area. However these midwives were not aware of the content of the intervention and they could not affect allocation of mothers. The mothers did not know if their antenatal midwife and postnatal nurse had had the process-oriented training program or not since randomization was done on municipality level. Hence the mothers were not aware if they belonged to intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Based on the findings of a baseline study, ten municipalities in the selected area were grouped into pairs according to size and breastfeeding duration. The antenatal and child health centers in these ten largest municipalities, were randomized to either the intervention site or the control site. Randomization was done by tossing a coin. Antenatal midwives and postnatal nurses at the intervention site were invited to the process-oriented training program.
The intervention was blinded for the mothers but not for participating midwives and post natal nurses, since the mothers did not know if they were cared for by health professionals that had had process oriented training or not
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A historical control group where data was collected before effects of the intervention could be detected and a simultaneous control group where data was collected at the same time as the invention group. Data was collected using questionnaires at three days and three and nine months after birth.
It should be noted that the mothers were not aware of if they were in the intervention or in any of the control groups
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
584
Accrual to date
Final
Recruitment outside Australia
Country [1] 3326 0
Sweden
State/province [1] 3326 0
West Gotaland

Funding & Sponsors
Funding source category [1] 264779 0
Charities/Societies/Foundations
Name [1] 264779 0
the Skaraborg Institute for Research and Development
Country [1] 264779 0
Sweden
Funding source category [2] 264780 0
Government body
Name [2] 264780 0
the Board of Research for Health and Caring Sciences, Swedish Research Council
Country [2] 264780 0
Sweden
Funding source category [3] 264781 0
University
Name [3] 264781 0
School of Life Sciences, University of Skovde
Country [3] 264781 0
Sweden
Funding source category [4] 264782 0
Hospital
Name [4] 264782 0
the Science Committee, Central Hospital, Skovde
Country [4] 264782 0
Sweden
Funding source category [5] 264783 0
Hospital
Name [5] 264783 0
the Primary Care Unit in Skaraborg
Country [5] 264783 0
Sweden
Primary sponsor type
University
Name
School of Life Sciences
Address
School of Life Sciences
University of Skovde
Box 408
S 541 28 Skovde
SWEDEN
Country
Sweden
Secondary sponsor category [1] 263896 0
Hospital
Name [1] 263896 0
the Primary Care Unit in Skaraborg
Address [1] 263896 0
the Primary Care Unit in Skaraborg
Regionens Hus
S 542 87 Mariestad
+46501 620 00
Country [1] 263896 0
Sweden
Other collaborator category [1] 251923 0
Hospital
Name [1] 251923 0
the Science Committee, Central Hospital, Skovde
Address [1] 251923 0
Karnsjukhuset i Skovde
S 541 85 Skovde
SWEDEN
+46500-43 10 00
Country [1] 251923 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266759 0
The Ethics Committee of the Medical Faculty of Gothenburg University, in Gothenburg, Sweden, approved the study L 188-99
Ethics committee address [1] 266759 0
Ethics committee country [1] 266759 0
Sweden
Date submitted for ethics approval [1] 266759 0
Approval date [1] 266759 0
19/04/1999
Ethics approval number [1] 266759 0
L 188 99

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

Contacts
Principal investigator
Name 32420 0
Address 32420 0
Country 32420 0
Phone 32420 0
Fax 32420 0
Email 32420 0
Contact person for public queries
Name 15667 0
Anette Ekstrom
Address 15667 0
School of Life sciences
University of Skovde
Box 408
S 541 28 Skovde
Country 15667 0
Sweden
Phone 15667 0
+46500 448414
Fax 15667 0
nil
Email 15667 0
[email protected]
Contact person for scientific queries
Name 6595 0
Anette Ekstrom
Address 6595 0
School of Life sciences
University of Skovde
Box 408
S 541 28 Skovde
Country 6595 0
Sweden
Phone 6595 0
+46500 448414
Fax 6595 0
Email 6595 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
EmbaseNurses and midwives professional support increases with improved attitudes - design and effects of a longitudinal randomized controlled process-oriented intervention.2015https://dx.doi.org/10.1186/s12884-015-0712-z
N.B. These documents automatically identified may not have been verified by the study sponsor.