Baby-Friendly Community Health Services Evaluation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Anne Berug, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01025362
First received: December 2, 2009
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The Norwegian Government's "The Norwegian Action Plan on Nutrition" (2007-2011) goal is to increase of the proportion of children receiving breast milk. The initiative "Baby-Friendly Community Health Services (BFCHS)" is one of the action plan's initiatives 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 counselling 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 their children for 4 months?
  • What effect does the certification process have on the proportion of mothers who breastfeed their children 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 clinic's breastfeeding counselling? Methods Cluster randomised 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 in order to map breastfeeding prevalence and the impression of community health services breastfeeding counselling of the mothers living in the participating community health service districts.

Post-survey: A corresponding data collection will be implemented after the initiative community health services have been certified as BFCHS. The post-survey will take place about two years after baseline.

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.


Condition Intervention Phase
Lactation
Behavioral: Lactation counseling
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Baby-Friendly Community Health Services Evaluation: A Cluster Randomised Controlled Study

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Breastfeeding prevalence [ Time Frame: infants age: six months and twelve months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mothers` perceived quality of lactation counselling [ Time Frame: Infant age, six and twelve months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1900
Study Start Date: August 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactation counseling Behavioral: Lactation counseling

Intervention arm:the well baby clinics will implement the Baby Friendly Initiative to improve their lactation counseling.

Control arm:Usual practice.

Other Name: Baby Friendly Hospital Initiative

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 behaviour 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 counselling 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 randomised 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.

  Eligibility

Ages Eligible for Study:   5 Months to 13 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers with infants of six and twelve months age.
  • Mothers who are able to understand Norwegian.

Exclusion Criteria:

  • Mothers who do not understand Norwegian.
  • Mothers with infants below six and months and abov twelve months age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025362

Contacts
Contact: Anne B Bærug, MSc 4723075400 ext 02 anne.baerug@ous-hf.no
Contact: Elisabeth Tufte, MPh 4723075408 etufte@ous-hf.no

Locations
Norway
Rikshospitalet HF Recruiting
Oslo, Norway, 0027
Contact: Anne B Bærug, MSc    4723075400 ext 02    anne.baerug@ous-hf.no   
Principal Investigator: Beate F Løland, Md PhD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Beate F Loland, Md PhD
  More Information

No publications provided

Responsible Party: Anne Berug, director, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01025362     History of Changes
Other Study ID Numbers: S-09277c2009/5783
Study First Received: December 2, 2009
Last Updated: July 9, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

ClinicalTrials.gov processed this record on August 18, 2014