Lactation Clinical Trial
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
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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