LactationNCT01025362
Baby-Friendly Community Health Services Evaluation
A study testing Lactation counseling in people with Lactation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The Norwegian Action Plan on Nutrition aim at increasing the prevalence of breastfeeding. The initiative "Baby-Friendly Community Health Services (BFCHS)" is an initiative to reach this goal. Read more about this study
- Who is it for?
- Ages 5 to 13 months
- Conditions the study is for
- Lactation
- What is being tested?
- Lactation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,032 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2009to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mothers with infants of five and eleven months age.
- Mothers who are able to understand Norwegian.
Who cannot join
- Mothers who do not understand Norwegian.
- Mothers with infants below five months and above twelve months age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baby-Friendly Community Health Services Evaluation: A Cluster Randomised Controlled Study
The Norwegian Action Plan on Nutrition aim at increasing the prevalence of breastfeeding. The initiative "Baby-Friendly Community Health Services (BFCHS)" is an initiative to reach this goal. BFCHS is developed from the concept "The Baby-Friendly Hospital Initiative" by WHO/UNICEF, and the intention is to increase the quality of breastfeeding counseling at Norwegian well-baby clinics.
The purpose of the study
Read more
The study seeks to answer the following research questions:
- What effect does the process of being certified as a BFCHS have on the proportion of mothers who exclusively breastfeed their children for 5 months?
- What effect does the process of being certified as a BFCHS have on the proportion of mothers who exclusively breastfeed for 4 months?
- What effect does the certification process have on the proportion of mothers who breastfeed at 11 months of age?
- What effect does the certification process have on the differences in breastfeeding due to social inequality?
- What effect does the certification process have on the mothers impression of the quality of the well-baby clinics lactation counseling?
- What effect does the certification process have on mothers satisfaction with the breastfeeding experience?
- What effect does the certification process have on perceived pressure to breastfeed? Methods Cluster randomized controlled study Sampling The survey unit, cluster, will be the community health services. All community health services in six counties in Norway will be invited to participate.
Inclusion criteria: Norwegian speaking mothers who have 5 month and 11 month old children.
Data collection Respondents are identified through the National Population Register (DSF). The data collection takes place using a postal questionnaire.
Baseline: Data collection before the intervention is implemented to assess breastfeeding prevalence and distribution of covariates in the two study arms.
Post-survey: The post-survey to assess the effect, will take place about two years after baseline when the community health services have been certified.
Sample size It is expected that the project could increase the breastfeeding prevalence with 5 percentage points. This assumption is the basis for the sample size. The initial aim is to recruit about 50 well-baby clinics.
Read the detailed description
In 2007 the Norwegian Government launched "The Norwegian Action Plan on Nutrition" (2007-2011) which emphasizes breast milk as optimal nutrition as well as being one of the most effective ways to promote health and prevent disease. It is well known that breast milk reduces the prevalence and severity of infectious diseases like diarrhoea, lower respiratory tract infections, ear infections, urinary tract infections as well as bacterial meningitis and necrotic enterocolitis. Current research suggests that breast milk can have long term health effects such as reduced risk of overweight, leukemia and diabetes type I and type II. Breastfeeding is associated with better cognitive development. Women who breastfeed also have significant added health benefits such as a reduced risk of breast cancer.
Almost all women produce breast milk, but the act of breastfeeding is a complicated interaction between mother and child and is affected by a number of factors. A large number of mothers have breastfeeding difficulties, and a significant number stop before they had intended to. If women were given qualified help it is possible that many of these problems could have been prevented or treated. In the Norwegian subsidiary study to The WHO Multicentre Growth Reference Study, where mothers received qualified breastfeeding instruction, 86% of children were exclusively breastfed at the 4 month stage as compared with the norm of 44%.
Today mothers are discharged earlier from hospital than ever before. Many of these women have not managed to properly establish breastfeeding. Due to this, many problems which were previously discovered in the maternity ward are now relegated to the primary health care services.
The disparity in breastfeeding between different socioeconomic groups in Norway primarily follows the same pattern as that found in health generally.For example, the chance that a mother with higher education will be breastfeeding her child at the age of 6 months is twice as high compared to a mother with only primary school education. Improving health service access to the entire population would contribute to advancing the health and health promoting behavior in those groups with the poorest prospects.
The National Resource Centre for Breastfeeding (NRCB) is cooperating with Norwegian Public Health Nurses Association and the Norwegian Directorate of Health in the initiative Baby-Friendly Community Health Services (BFCHS). The purpose of this initiative is to improve the quality of breastfeeding advice at Norwegian community health services.
While WHO has developed an international standard for breastfeeding counseling for maternity wards, there is no similar standard for primary care services as yet.
A newly updated Cochrane-overview about the effect of offering support to breastfeeding mothers identified 16 studies which assessed the effect of support from health workers. The studies showed a small effect on all breastfeeding at the four month stage, but could not show any difference at other stages. An American survey identified 38 randomized controlled studies on the effect of initiatives in primary care services to promote breastfeeding, all from industrialized countries.This review indicates that initiatives to increase the competency of health workers can have a positive effect on the prevalence of breastfeeding.
- Conditions
- Lactation
- Being tested
- Lactation counseling, Standard care
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactation counselingBehavioural
Also called The Baby-Friendly Community Health Service
The Baby-Friendly Community Health Service intervention to improve quality of lactation counseling.
Standard careBehavioural
Child Health Services offered standard care
| Study group | Role | What they receive |
|---|---|---|
| Lactation counseling | Experimental | Intervention arm: The mother and child health centres will implement The Baby-Friendly Initiative to improve their lactation counseling.
Other Names: The Baby Friendly Community Health Service Receives: Behavioral: Lactation counseling |
| Standard care | Active comparator | The comparison group was mother and child health centres which continued offering standard care. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding prevalence
Measured: infants age: five months
Secondary outcomes (5)
Exclusive breastfeeding prevalence
Measured: infants age: 4 months
Any breastfeeding prevalence
Measured: infants age: 5 months and 11 months
Mothers perception of quality of lactation counselling
Measured: infants age: 5 months
Mothers satisfaction with the breastfeeding experience
Measured: Infants age: 6 months
Mothers perception of breastfeeding pressure
Measured: Infants age: 6 mon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LactationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Berug, Oslo University Hospital
- Investigators
- Beate F Loland, Md PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025362
- Sponsor's protocol ID
- S-09277c2009/5783
- Status last verified
- Oct 2014
- First submitted
- 2 Dec 2009
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baerug A, Laake P, Loland BF, Tylleskar T, Tufte E, Fretheim A. Explaining socioeconomic inequalities in exclusive breast feeding in Norway. Arch Dis Child. 2017 Aug;102(8):708-714. doi: 10.1136/archdischild-2016-312038. Epub 2017 Feb 24.
PubMed 28235835
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby-Friendly Community Health Services Evaluation: A Cluster Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01025362
- Acronym / sponsor ID
- S-09277c2009/5783
- Conditions
- Lactation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,032 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Norwegian Action Plan on Nutrition aim at increasing the prevalence of breastfeeding. The initiative "Baby-Friendly Community Health Services (BFCHS)" is an initiative to reach this goal. BFCHS is developed from the concept "The Baby-Friendly Hospital Initiative" by WHO/UNICEF, and the intention is to increase the quality of breastfeeding counseling at Norwegian well-baby clinics.
The purpose of the study
The study seeks to answer the following research questions:
- What effect does the process of being certified as a BFCHS have on the proportion of mothers who exclusively breastfeed their children for 5 months?
- What effect does the process of being certified as a BFCHS have on the proportion of mothers who exclusively breastfeed for 4 months?
- What effect does the certification process have on the proportion of mothers who breastfeed at 11 months of age?
- What effect does the certification process have on the differences in breastfeeding due to social inequality?
- What effect does the certification process have on the mothers impression of the quality of the well-baby clinics lactation counseling?
- What effect does the certification process have on mothers satisfaction with the breastfeeding experience?
- What effect does the certification process have on perceived pressure to breastfeed? Methods Cluster randomized controlled study Sampling The survey unit, cluster, will be the community health services. All community health services in six counties in Norway will be invited to participate.
Inclusion criteria: Norwegian speaking mothers who have 5 month and 11 month old children.
Data collection Respondents are identified through the National Population Register (DSF). The data collection takes place using a postal questionnaire.
Baseline: Data collection before the intervention is implemented to assess breastfeeding prevalence and distribution of covariates in the two study arms.
Post-survey: The post-survey to assess the effect, will take place about two years after baseline when the community health services have been certified.
Sample size It is expected that the project could increase the breastfeeding prevalence with 5 percentage points. This assumption is the basis for the sample size. The initial aim is to recruit about 50 well-baby clinics.
Detailed description
In 2007 the Norwegian Government launched "The Norwegian Action Plan on Nutrition" (2007-2011) which emphasizes breast milk as optimal nutrition as well as being one of the most effective ways to promote health and prevent disease. It is well known that breast milk reduces the prevalence and severity of infectious diseases like diarrhoea, lower respiratory tract infections, ear infections, urinary tract infections as well as bacterial meningitis and necrotic enterocolitis. Current research suggests that breast milk can have long term health effects such as reduced risk of overweight, leukemia and diabetes type I and type II. Breastfeeding is associated with better cognitive development. Women who breastfeed also have significant added health benefits such as a reduced risk of breast cancer.
Almost all women produce breast milk, but the act of breastfeeding is a complicated interaction between mother and child and is affected by a number of factors. A large number of mothers have breastfeeding difficulties, and a significant number stop before they had intended to. If women were given qualified help it is possible that many of these problems could have been prevented or treated. In the Norwegian subsidiary study to The WHO Multicentre Growth Reference Study, where mothers received qualified breastfeeding instruction, 86% of children were exclusively breastfed at the 4 month stage as compared with the norm of 44%.
Today mothers are discharged earlier from hospital than ever before. Many of these women have not managed to properly establish breastfeeding. Due to this, many problems which were previously discovered in the maternity ward are now relegated to the primary health care services.
The disparity in breastfeeding between different socioeconomic groups in Norway primarily follows the same pattern as that found in health generally.For example, the chance that a mother with higher education will be breastfeeding her child at the age of 6 months is twice as high compared to a mother with only primary school education. Improving health service access to the entire population would contribute to advancing the health and health promoting behavior in those groups with the poorest prospects.
The National Resource Centre for Breastfeeding (NRCB) is cooperating with Norwegian Public Health Nurses Association and the Norwegian Directorate of Health in the initiative Baby-Friendly Community Health Services (BFCHS). The purpose of this initiative is to improve the quality of breastfeeding advice at Norwegian community health services.
While WHO has developed an international standard for breastfeeding counseling for maternity wards, there is no similar standard for primary care services as yet.
A newly updated Cochrane-overview about the effect of offering support to breastfeeding mothers identified 16 studies which assessed the effect of support from health workers. The studies showed a small effect on all breastfeeding at the four month stage, but could not show any difference at other stages. An American survey identified 38 randomized controlled studies on the effect of initiatives in primary care services to promote breastfeeding, all from industrialized countries.This review indicates that initiatives to increase the competency of health workers can have a positive effect on the prevalence of breastfeeding.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactation counseling | Experimental | Behavioral: Lactation counselingIntervention arm: The mother and child health centres will implement The Baby-Friendly Initiative to improve their lactation counseling. Other Names: The Baby Friendly Community Health Service |
| Standard care | Active comparator | Behavioral: Standard careThe comparison group was mother and child health centres which continued offering standard care. |
Who may qualify
- Ages
- 5 to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Mothers with infants of five and eleven months age.
- Mothers who are able to understand Norwegian.
Key exclusion criteria (2 listed)
- Mothers who do not understand Norwegian.
- Mothers with infants below five months and above twelve months age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactation counselingAlso: The Baby-Friendly Community Health ServiceThe Baby-Friendly Community Health Service intervention to improve quality of lactation counseling. | Behavioural | Lactation counseling |
| Standard careChild Health Services offered standard care | Behavioural | Standard care |
Primary outcome
Exclusive breastfeeding prevalence
Time frame: infants age: five months
5 secondary outcomes
Exclusive breastfeeding prevalence
Time frame: infants age: 4 months
Any breastfeeding prevalence
Time frame: infants age: 5 months and 11 months
Mothers perception of quality of lactation counselling
Time frame: infants age: 5 months
Mothers satisfaction with the breastfeeding experience
Time frame: Infants age: 6 months
Mothers perception of breastfeeding pressure
Time frame: Infants age: 6 mon
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Derived from this study: PubMed 28235835Baerug A, Laake P, Loland BF, Tylleskar T, Tufte E, Fretheim A. Explaining socioeconomic inequalities in exclusive breast feeding in Norway. Arch Dis Child. 2017 Aug;102(8):708-714. doi: 10.1136/archdischild-2016-312038. Epub 2017 Feb 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate F Loland, Md PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactation counseling in people with Lactation, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding prevalence (time frame: infants age: five months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01025362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.