Trial record 1 of 566 for:    breastfeeding
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Proactive Breastfeeding Support in First Time Mothers

This study is not yet open for participant recruitment.
Verified November 2013 by University of Split
Sponsor:
Information provided by (Responsible Party):
Irena Zakarija-Grkovic, University of Split
ClinicalTrials.gov Identifier:
NCT01998087
First received: November 22, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

In Croatia, between 95% and 98% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any breast 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 information and phone calls. This will be tested by randomising women, attending their primary health care provider for routine antenatal visits between 27 and 32 weeks, to an intervention educational program focused on promoting and supporting breastfeeding, and to a control group who will receive educational support aimed at general pregnancy and parenting issues. 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, quality of life, social support and attitudes toward infant feeding


Condition Intervention
Breastfeeding
Behavioral: Breastfeeding support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Written Breastfeeding Information in Pregnancy and Breastfeeding Support Phone Calls to First Time Mothers on Breastfeeding Rates Versus General Pregnancy and Parenting Information and Phone Calls: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Split:

Primary Outcome Measures:
  • Exclusive breastfeeding [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Any breastfeeding [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exclusive breastfeeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Any breastfeeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Maternal attitudes toward infant feeding [ Time Frame: Before (at recruitment) and after (at 3 months) ] [ Designated as safety issue: No ]
    Validated Iowa Infant Feeding Attitude Scale to be used.

  • Quality of Life [ Time Frame: Before (at recruitment) and after interventions (at 3 months) ] [ Designated as safety issue: No ]
    Standardised tool

  • Breastfeeding self-efficacy scale [ Time Frame: At 3 & 6 months post birth ] [ Designated as safety issue: No ]
    Validated tool measuring a mother's confidence in her ability to breastfeed


Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breastfeeding support
A breastfeeding brochure will be distributed to expectant mothers at 27 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three standardized phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following birth of the baby.
Behavioral: Breastfeeding support
A breastfeeding brochure will be distributed to expectant mothers at 27 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following the birth of the baby.
Active Comparator: Control group
The control group of mothers will receive a brochure in pregnancy covering general pregnancy and parenting issues and follow-up phone calls but breastfeeding issues will not be specifically addressed. If a mother raises any breastfeeding issue she will be referred to appropriate support.
Behavioral: Breastfeeding support
A breastfeeding brochure will be distributed to expectant mothers at 27 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following the birth of the baby.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • expectant women, between 27 and 32 weeks gestation, attending any of 4 pre- determined antenatal clinics
  • primigravidae
  • can read and write Croatian
  • resides in Croatia or plans to stay in Croatia until 6 months following the birth

Exclusion Criteria:

  • multigravidae
  • women expecting twins/multiples
  • refuses to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01998087

Contacts
Contact: Drita Puharic, RN, MSc ++385989035526 drita.puharic@hotmail.com

Sponsors and Collaborators
University of Split
Investigators
Principal Investigator: Irena Zakarija-Grkovic, MD, PhD University of Split
  More Information

No publications provided

Responsible Party: Irena Zakarija-Grkovic, Lecturer/researcher, University of Split
ClinicalTrials.gov Identifier: NCT01998087     History of Changes
Other Study ID Numbers: 2181-198-03-04-13-0027
Study First Received: November 22, 2013
Last Updated: November 27, 2013
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Split:
Breastfeeding
Exclusive breastfeeding
Proactive breastfeeding support
Telephone breastfeeding support
Infant feeding attitudes
Breastfeeding self-efficacy

ClinicalTrials.gov processed this record on April 16, 2014