Baby-Friendly Community Health Services Evaluation

NCT01025362 | Completed DMC

• 1 other identifier: S-09277c2009/5783
• Study Type: interventional
• Target: 2,032
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lactation

Outcome Measures

Primary Outcomes (1)

• Exclusive breastfeeding prevalence

  infants age: five months

Secondary Outcomes (5)

• Exclusive breastfeeding prevalence

  infants age: 4 months

• Any breastfeeding prevalence

  infants age: 5 months and 11 months

• Mothers perception of quality of lactation counselling

  infants age: 5 months

• Mothers satisfaction with the breastfeeding experience

  Infants age: 6 months

• Mothers perception of breastfeeding pressure

  Infants age: 6 mon

Study Arms (2)

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

Behavioral: Lactation counseling

Standard care

ACTIVE COMPARATOR

The comparison group was mother and child health centres which continued offering standard care.

Behavioral: Standard care

Interventions

Lactation counseling BEHAVIORAL

The Baby-Friendly Community Health Service intervention to improve quality of lactation counseling.

Also known as: The Baby-Friendly Community Health Service

Lactation counseling

Standard care BEHAVIORAL

Child Health Services offered standard care

Standard care

Eligibility Criteria

• Age: 5 Months - 13 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Mothers with infants of five and eleven months age.
• Mothers who are able to understand Norwegian.

You may not qualify if:

• Mothers who do not understand Norwegian.
• Mothers with infants below five months and above twelve months age.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Rikshospitalet HF

Oslo, 0027, Norway

Location

Related Publications (1)

• 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.

  PMID: 28235835 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Beate F Loland, Md PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

NO (1)