Clinical trial NCT01998087: Proactive Breastfeeding Support in First Time Mothers
Official title: The Effect of Written Information and Support Phone Calls for First Time Mothers on Breastfeeding Rates: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding
Keywords: Exclusive breastfeeding
Breastfeeding
Proactive breastfeeding support
Telephone breastfeeding support
Infant feeding attitudes
Breastfeeding self-efficacy
Breastfeeding difficulties
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any human milk for their babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other pregnancy and parenting related written information is routinely provided to expectant couples. In our study we would like to find out whether providing written breastfeeding information in pregnancy and breastfeeding focused support phone calls during pregnancy and after the birth of the baby result in better outcomes than providing general pregnancy/parenting information and support phone calls. This will be tested by randomising women, attending their primary health care provider for routine antenatal visits between 20 and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an intervention focused on general pregnancy and parenting issues, and to a non-intervention control group. Women will be followed-up for 6 months after the birth of their baby and data will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy, breastfeeding difficulties, social support and attitudes toward infant feeding.


Eligibility criteria: Inclusion Criteria:

* expectant women, between 20 and 32 weeks gestation, attending any of 6 pre- determined antenatal clinics
* primigravidae
* singleton pregnancy
* can read and write Croatian
* resides in Croatia or plans to stay in Croatia at least 12 months following the birth

Exclusion Criteria:

* multigravidae
* women expecting twins/multiples
* refuses to participate
* inability to communicate in Croatian by phone
* planning to leave the County of Split Dalmatia within a year of giving birth
* severe maternal psychiatric or medical problems

Primary outcomes:
measure: Exclusive breastfeeding
timeFrame: 3 months
Secondary outcomes:
measure: Any breastfeeding
timeFrame: 3 & 6 months
Other outcomes:
measure: Maternal attitudes toward infant feeding
timeFrame: Before (at recruitment) and after (at 3 months)
measure: Breastfeeding self-efficacy scale
timeFrame: At 3 months post birth
measure: Breastfeeding difficulties
timeFrame: At 3 months postbirth
Locations:
city: Split
country: Croatia
facility: Cito Obstetrics and Gynaecology Clinic
state: Outside AUS
Study officials:
affiliation: University Hospital of Split
name: Irena Zakarija-Grkovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puharic D, Malicki M, Borovac JA, Sparac V, Poljak B, Aracic N, Marinovic N, Luetic N, Zakarija-Grkovic I. The effect of a combined intervention on exclusive breastfeeding in primiparas: A randomised controlled trial. Matern Child Nutr. 2020 Jul;16(3):e12948. doi: 10.1111/mcn.12948. Epub 2020 Jan 13.