NCT03890978

Brief Summary

World Health Organization (2001) recommended that infants should be exclusively breastfed for the first 6 months and could be continued in the second year of life or longer. The rate of exclusive breastfeeding (EBF) in Jordan is in progressive decline. In 2002 the EBF rate among babies less than 6 months old was 26.7% and unfortunately this rate dropped to 22% in 2007 and to 23% in 2012. In Jordan, 68% of babies receive breast milk within 24 hours of birth and the large majority continues to do so for 12.5 months, but EBF rates are very low. While health and nutrition experts recommend that introduction of complementary foods should start only when an infant is six months old, other liquids such as water, juice, and formula milk are being introduced to most Jordanian infants in the first couple of months . Thus, urgent attention is directed towards improving exclusive breastfeeding rates during the first six months of life.Despite scientific evidence concerning the benefits of breast milk, the practice of EBF is still uncommon in Jordan. Even with the consolidation of numerous strategies to promote breastfeeding and the general public health recommendation that infants should be exclusively breastfed during the first six months of life, the duration of breastfeeding in Jordan is in progressive decline and the percentage of infants exclusively breastfed for the first six months of life is still low and worrisome. A review of previous studies in Jordan, showed that most of these are descriptive studies focused on studying the factors affecting the rate of EBF and the reasons why women stop breastfeeding their children. There is no study on improving EBF for women in Jordan so far. To date there have been no interventions using mobile phones to improve breastfeeding and other feeding practices in Jordan. The aim of this research is to improve the EBF rates and duration through using a mobile phone-based EBF promotion (Text message). A randomized controlled trial with follow-up from recruitment until 6 months post-delivery will be conducted to implement EBF promotion intervention using mobile phone text messages in southern Jordan, and evaluate its impact on breastfeeding practices. The intervention group will receive EBF promotional messages and the control group will receive child health care-related messages (except breastfeeding messages) from the time of discharge until 6 months post delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

March 24, 2019

Last Update Submit

March 26, 2019

Conditions

Keywords

exclusive, breastfeeding, text messages, Jordan

Outcome Measures

Primary Outcomes (1)

  • The rate of the Exclusive Breastfeeding

    The primary outcome is the rate of EBF at 1 to 6 months of the infants' age measured at monthly intervals after delivery

    from birth of baby to 6 months post birth

Secondary Outcomes (2)

  • median duration of EBF

    from birth of baby to 6 months post birth

  • rates of early initiation of breastfeeding

    within 1 hour after birth

Study Arms (2)

intervention

EXPERIMENTAL

The intervention group will receive EBF promotional messages from the time of discharge until 6 months post delivery.

Other: promotional Exclusive breastfeeding text messages

control

OTHER

the control group will receive child health care-related messages (except breastfeeding messages) from the time of discharge until 6 months post delivery.

Other: promotional Exclusive breastfeeding text messages

Interventions

promotional Exclusive breastfeeding text messages will be send to women via mobile phone

controlintervention

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • speak and write in Arabic language
  • could access a mobile phone that could display Arabic language fonts,
  • express interest in breastfeeding
  • had an uncomplicated singleton pregnancy
  • who lived in an area with mobile network coverage

You may not qualify if:

  • Non-Arabic speaking mothers
  • who do not express interest in breastfeeding
  • had pregnancy complications, a multiple pregnancy, and known medical conditions including mental illness that might hinder breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry Of Health

Karak, 61166, Jordan

Location

Related Publications (21)

  • Abuidhail J, Al-Modallal H, Yousif R, Almresi N. Exclusive breast feeding (EBF) in Jordan: prevalence, duration, practices, and barriers. Midwifery. 2014 Mar;30(3):331-7. doi: 10.1016/j.midw.2013.01.005. Epub 2013 Feb 26.

    PMID: 23484776BACKGROUND
  • Ahmed AH, Ouzzani M. Interactive web-based breastfeeding monitoring: feasibility, usability, and acceptability. J Hum Lact. 2012 Nov;28(4):468-75. doi: 10.1177/0890334412451869. Epub 2012 Aug 3.

    PMID: 22864059BACKGROUND
  • Akca A, Corbacioglu Esmer A, Ozyurek ES, Aydin A, Korkmaz N, Gorgen H, Akbayir O. The influence of the systematic birth preparation program on childbirth satisfaction. Arch Gynecol Obstet. 2017 May;295(5):1127-1133. doi: 10.1007/s00404-017-4345-5. Epub 2017 Mar 16.

    PMID: 28303340BACKGROUND
  • Al Juaid DA, Binns CW, Giglia RC. Breastfeeding in Saudi Arabia: a review. Int Breastfeed J. 2014 Jan 14;9(1):1. doi: 10.1186/1746-4358-9-1.

    PMID: 24422991BACKGROUND
  • Alzaheb RA. Factors Influencing Exclusive Breastfeeding in Tabuk, Saudi Arabia. Clin Med Insights Pediatr. 2017 Mar 10;11:1179556517698136. doi: 10.1177/1179556517698136. eCollection 2017.

    PMID: 28469519BACKGROUND
  • Araban M, Karimian Z, Karimian Kakolaki Z, McQueen KA, Dennis CL. Randomized Controlled Trial of a Prenatal Breastfeeding Self-Efficacy Intervention in Primiparous Women in Iran. J Obstet Gynecol Neonatal Nurs. 2018 Mar;47(2):173-183. doi: 10.1016/j.jogn.2018.01.005. Epub 2018 Feb 3.

    PMID: 29406289BACKGROUND
  • Dennis CL, Kingston D. A systematic review of telephone support for women during pregnancy and the early postpartum period. J Obstet Gynecol Neonatal Nurs. 2008 May-Jun;37(3):301-14. doi: 10.1111/j.1552-6909.2008.00235.x.

    PMID: 18507601BACKGROUND
  • Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

    PMID: 14649593BACKGROUND
  • Flax VL, Negerie M, Ibrahim AU, Leatherman S, Daza EJ, Bentley ME. Integrating group counseling, cell phone messaging, and participant-generated songs and dramas into a microcredit program increases Nigerian women's adherence to international breastfeeding recommendations. J Nutr. 2014 Jul;144(7):1120-4. doi: 10.3945/jn.113.190124. Epub 2014 May 8.

    PMID: 24812071BACKGROUND
  • Gallegos D, Russell-Bennett R, Previte J, Parkinson J. Can a text message a week improve breastfeeding? BMC Pregnancy Childbirth. 2014 Nov 6;14:374. doi: 10.1186/s12884-014-0374-2.

    PMID: 25369808BACKGROUND
  • Jiang H, Li M, Wen LM, Hu Q, Yang D, He G, Baur LA, Dibley MJ, Qian X. Effect of short message service on infant feeding practice: findings from a community-based study in Shanghai, China. JAMA Pediatr. 2014 May;168(5):471-8. doi: 10.1001/jamapediatrics.2014.58.

    PMID: 24639004BACKGROUND
  • Jones JR, Kogan MD, Singh GK, Dee DL, Grummer-Strawn LM. Factors associated with exclusive breastfeeding in the United States. Pediatrics. 2011 Dec;128(6):1117-25. doi: 10.1542/peds.2011-0841. Epub 2011 Nov 28.

    PMID: 22123898BACKGROUND
  • Jordan ET, Ray EM, Johnson P, Evans WD. Text4Baby: using text messaging to improve maternal and newborn health. Nurs Womens Health. 2011 Jun-Jul;15(3):206-12. doi: 10.1111/j.1751-486X.2011.01635.x. No abstract available.

    PMID: 21672170BACKGROUND
  • Kannisto KA, Koivunen MH, Valimaki MA. Use of mobile phone text message reminders in health care services: a narrative literature review. J Med Internet Res. 2014 Oct 17;16(10):e222. doi: 10.2196/jmir.3442.

    PMID: 25326646BACKGROUND
  • Khasawneh W, Khasawneh AA. Predictors and barriers to breastfeeding in north of Jordan: could we do better? Int Breastfeed J. 2017 Dec 8;12:49. doi: 10.1186/s13006-017-0140-y. eCollection 2017.

    PMID: 29234457BACKGROUND
  • Khresheh R, Suhaimat A, Jalamdeh F, Barclay L. The effect of a postnatal education and support program on breastfeeding among primiparous women: a randomized controlled trial. Int J Nurs Stud. 2011 Sep;48(9):1058-65. doi: 10.1016/j.ijnurstu.2011.02.001. Epub 2011 Feb 24.

    PMID: 21353220BACKGROUND
  • Odone A, Ferrari A, Spagnoli F, Visciarelli S, Shefer A, Pasquarella C, Signorelli C. Effectiveness of interventions that apply new media to improve vaccine uptake and vaccine coverage. Hum Vaccin Immunother. 2015;11(1):72-82. doi: 10.4161/hv.34313. Epub 2014 Nov 1.

    PMID: 25483518BACKGROUND
  • Oweis A, Tayem A, Froelicher ES. Breastfeeding practices among Jordanian women. Int J Nurs Pract. 2009 Feb;15(1):32-40. doi: 10.1111/j.1440-172X.2008.01720.x.

    PMID: 19187167BACKGROUND
  • Racine EF, Frick K, Guthrie JF, Strobino D. Individual net-benefit maximization: a model for understanding breastfeeding cessation among low-income women. Matern Child Health J. 2009 Mar;13(2):241-9. doi: 10.1007/s10995-008-0337-1. Epub 2008 Mar 21.

    PMID: 18357417BACKGROUND
  • Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.

    PMID: 27060875BACKGROUND
  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Reham M Khresheh, PhD

    Mutah University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reham Mohammad Khresheh

Study Record Dates

First Submitted

March 24, 2019

First Posted

March 26, 2019

Study Start

January 1, 2018

Primary Completion

September 20, 2018

Study Completion

March 20, 2019

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations