BreastfeedingNCT03890978
Improving Exclusive Breastfeeding Via Mobile Phone Text Messages
A study testing promotional Exclusive breastfeeding text messages in people with Breastfeeding, run by Mutah University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- promotional Exclusive breastfeeding text messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2018to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Exclusive Breastfeeding Via Mobile Phone Text Messages: a Randomized Controlled Trial in Southern Jordan
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.
Read the detailed description
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. Exclusive breastfeeding (no additional food, liquids or water) for the first six months helps protect children against diseases, supports healthy brain development and is associated with better educational achievement (World Health Organization, 2013). Breastfeeding is known to provide nutritional, immunologic, psychological, social, economic, and environmental benefits (World Health Organization, 2013, 2013b) and promote stronger attachment between mother and baby (Rapley, 2002). Evidence from the literature strongly indicate that this optimal method of infant feeding should be encouraged to ensure the best possible health outcomes for women and their children(Racine, Frick, Guthrie, \& Strobino, 2009). However, few of the world's newborns, including in Jordan, are exclusively breastfed for the first six months of life.
In Jordan, religion and culture support breastfeeding, but still the breastfeeding practices are not optimal. 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 (Department of Statistics 2013). 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(Department of Statistics 2013). 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(World Health Organization, 2001). Thus, urgent attention is directed towards improving exclusive breastfeeding rates during the first six months of life.
Research studies to date examining breastfeeding practices in both developed and developing countries have found high rates of breastfeeding initiation and also that this high initiation rate is accompanied by a sharp fall in EBF in the first 6 months of life(Alzaheb, 2017; Jones, Kogan, Singh, Dee, \& Grummer-Strawn, 2011). For example in Australia a high initiation rate of 92% was found for EBF from 2004 to 2005 , this rate then dropped to 71% of infants who exclusively breastfed at 1 month of age, 56% at 3 months, and 14% at 6 months (Akca, et al., 2017). Similarly, in Jordan, findings from a recent research study indicate that 51% of infants began EBF within 24 hours, falling to 47% at 1 month of age, and 33% at 6 months (Khasawneh \& Khasawneh, 2017).
Significance of the study 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).
METHODS Design 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.
Hypothesis 1- The primary hypothesis of the proposed study is: The EBF rates in the intervention group during the 6 months after delivery will increase 2- fold that of the control group.
- The secondary hypotheses are: Receiving breastfeeding promotional text messages will result in higher appropriate infant feeding practices in the intervention group compared to that of the control group.
Setting The study will be conducted at Al-Karak hospital the main governmental and teaching hospital in the southern region of Jordan. In 2016 the hospital reported that on average 2,808 births occurred, 59% were caesarean births (Ministry of Health, 2017). In this hospital, there is a higher possibility of recruiting women from a diverse range of socioeconomic backgrounds. The hospital is accredited as a baby friendly hospital initiative and follows guidelines to provide early initiation of breastfeeding. The hospital has a policy to encourage mothers to give colostrum to babies within 1 hour after birth regardless of the type of delivery.
Study population Inclusion criteria will be mothers who (1) are 18 years of age and older, (2) speak and write in Arabic language, (3) could access a mobile phone that could display Arabic language fonts,(4) express interest in breastfeeding, (5) had an uncomplicated singleton pregnancy, and who lived in an area with mobile network coverage. Exclusion criteria will be (1) Non-Arabic speaking mothers, (2) who do not express interest in breastfeeding, (3) had pregnancy complications, a multiple pregnancy, and known medical conditions including mental illness that might hinder breastfeeding.
Recruitment, Assignment, and Allocation Participant eligibility will be accessed via a hospital attendance registry (used by hospital staff) in which information such as age, address, and phone numbers are recorded. At recruitment, researcher will identify potential participants with the help of hospital nurses, explained the study, provided an information statement and consent form written in Arabic, and confirmed eligibility. If a mother agreed to participate, informed consent will be obtained, and she will be requested to complete the baseline survey questions. The participant's mobile phone will be checked for compatibility with text messages and, if needed, brief training on how to read text messages will be provided.
Eligible mothers will be randomized to the intervention or control group according to an allocation sequence that will be generated by the researcher using a computer program. Each study and group number will be kept in an opaque envelope to conceal the allocation sequence and securely stored. At recruitment, researcher sequentially will take an envelope for each consenting participant and conducted the baseline interview to collect baseline data. After the participant's information is recorded, the envelope will be opened and the group allocation will be recorded.
Blinding Because the intervention could not be blinded, bias will be minimized by ensuring both groups received messages and by not explaining in the consent and information sheets how the text messages differed between groups. The information statement that will be provided only general information that each participant could be allocated randomly into a group; will receive messages containing information on childcare, and breastfeeding practices; and that the frequency of messages could vary from 1 to 3 times per week. Research staff and interviewers (via telephone) will be blinded to each participant's group status although they might guess the group based on participants' responses. To minimize bias, we will also blind research staff to the trial aims and hypotheses.
Sample size Sample size was calculated with median effect size, 95% power, 5% alpha, and 25% expected loss at follow-up. The estimated sample size is 210 (105 per group) and the final sample size requirement will be 260 participants to allow for 25% loss at follow-up, 130 each group.
Data collection Baseline data will be collected from mothers during recruitment. Follow-up (outcome) data will be collected by monthly phone calls at 1 to 6 months post delivery.
Baseline Data Collection
- A structured form (appendix 1) will be use to collect baseline data prior to discharge, participants will be asked to provide information on their socioeconomic status, previous pregnancies and breastfeeding history, knowledge and sources of breastfeeding information, intention to breastfeed, and intended breastfeeding patterns.
- Also information on childbirth outcomes will be collected including type of delivery and the newborn's birth weight, sex, and perinatal outcomes.
- Breastfeeding self efficacy will be assessed before discharge using the Arabic version breastfeeding self-efficacy scale(C. L. Dennis, 2003). The short form of the instrument, the BSES-SF, which was developed by Dennis, retains only 14 of the original 33 items and has also been shown to be a reliable (Cronbach's alpha coefficient was 0.94) and a valid measure of breast-feeding self-efficacy and to predict breast-feeding initiation, duration, and exclusivity (C. L. Dennis, 2003). The BSES-SF is made up of 14 items based on 5-point likert scale, where the mothers respond to each of the statements by checking a number from 1 to 5, whereby 1 denotes "not at all confident" and 5 denotes "very confident". All items are presented positively and begin by the idiom "I can always".
Follow-Up Data Collection Follow-up data collection will comprise feeding follow-up assessments, morbidity, breastfeeding self-efficacy Scale.
- The feeding follow-up form (appendix 2) will be completed every month and asked if the infant is breastfed and if other liquids or foods were given in the last 24 hours and over the preceding month since the last contact (or birth for the first follow-up). Each participant will complete 6 assessments of their feeding practices, including detailed information about the different types of liquids and foods.
- Child morbidity status (appendix 2) will be assessed when the child is 1, 3, and 5 months of age using a structured form. Child morbidity questions (ref) will be used to record whether the child has had any signs or symptoms such as fever, cough, cold, running nose, rapid breathing, and difficulty in breathing, chest in drawing, and diarrhea and dysentery. If one of these was present, duration of illness will be further explored
- Breastfeeding self-efficacy will be collected at 1, 3, and 5 months post delivery to ascertain the mothers' confidence to breastfeed, the relationship between self-efficacy and breastfeeding duration, and whether text messages improved breastfeeding self-efficacy.
Outcome Measures The primary outcome is the rate of EBF at 1 to 6 months of the infants' age measured at monthly intervals after delivery. Secondary outcomes are median duration of EBF and rates of early initiation of breastfeeding (within 1 hour after birth); predominant breastfeeding; current breastfeeding; bottle feeding; and early introduction of solid, semisolid, or soft foods at 1 to 6 months of infant's age (measured at monthly intervals).
Data analysis Outcomes will be compared between groups using t-test for parametric data and Wilcoxon rank sum for nonparametric data.
Ethical consideration Approval to conduct the study will be obtained from the ethics committee at faculty of nursing / Mutah University and the Ministry of Health (MOH). Mothers will be informed about the study and verbal and written consent for agreement will be obtained from each mother . Mothers will be assured that participation is voluntary and they have the right to withdraw from the study at any time without giving any reason. Mothers will be assured that their information will not be recognized in any products of this research. Data will be stored on computer and accessed only by the principal investigator.
- Conditions
- Breastfeeding
- Being tested
- promotional Exclusive breastfeeding text messages
- Keywords
- exclusive, breastfeeding, text messages, Jordan
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
promotional Exclusive breastfeeding text messagesOther
promotional Exclusive breastfeeding text messages will be send to women via mobile phone
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | The intervention group will receive EBF promotional messages from the time of discharge until 6 months post delivery. Receives: 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. Receives: Other: promotional Exclusive breastfeeding text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from birth of baby to 6 months post birth
Secondary outcomes (2)
median duration of EBF
duration of exclusive breastfeeding
Measured: from birth of baby to 6 months post birth
rates of early initiation of breastfeeding
ates of early initiation of breastfeeding
Measured: within 1 hour after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Jan 2018
- Primary completion20 Sep 2018
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mohammad Khresheh, Mutah University
- Investigators
- Reham M Khresheh, PhD, Principal investigator, Mutah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890978
- Sponsor's protocol ID
- 2432019
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23484776Ahmed 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.
PubMed 22864059Akca 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.
PubMed 28303340Al 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.
PubMed 24422991Alzaheb RA. Factors Influencing Exclusive Breastfeeding in Tabuk, Saudi Arabia. Clin Med Insights Pediatr. 2017 Mar 10;11:1179556517698136. doi: 10.1177/1179556517698136. eCollection 2017.
PubMed 28469519Araban 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.
PubMed 29406289Dennis 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.
PubMed 18507601Dennis 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.
PubMed 14649593Flax 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.
PubMed 24812071Gallegos 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.
PubMed 25369808Jiang 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.
PubMed 24639004Jones 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.
PubMed 22123898Jordan 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.
PubMed 21672170Kannisto 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.
PubMed 25326646Khasawneh 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.
PubMed 29234457
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Exclusive Breastfeeding Via Mobile Phone Text Messages: a Randomized Controlled Trial in Southern Jordan
- ClinicalTrials.gov ID
- NCT03890978
- Acronym / sponsor ID
- 2432019
- Conditions
- Breastfeeding
- Keywords
- exclusive, breastfeeding, text messages, Jordan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Mutah UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Exclusive breastfeeding (no additional food, liquids or water) for the first six months helps protect children against diseases, supports healthy brain development and is associated with better educational achievement (World Health Organization, 2013). Breastfeeding is known to provide nutritional, immunologic, psychological, social, economic, and environmental benefits (World Health Organization, 2013, 2013b) and promote stronger attachment between mother and baby (Rapley, 2002). Evidence from the literature strongly indicate that this optimal method of infant feeding should be encouraged to ensure the best possible health outcomes for women and their children(Racine, Frick, Guthrie, \& Strobino, 2009). However, few of the world's newborns, including in Jordan, are exclusively breastfed for the first six months of life.
In Jordan, religion and culture support breastfeeding, but still the breastfeeding practices are not optimal. 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 (Department of Statistics 2013). 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(Department of Statistics 2013). 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(World Health Organization, 2001). Thus, urgent attention is directed towards improving exclusive breastfeeding rates during the first six months of life.
Research studies to date examining breastfeeding practices in both developed and developing countries have found high rates of breastfeeding initiation and also that this high initiation rate is accompanied by a sharp fall in EBF in the first 6 months of life(Alzaheb, 2017; Jones, Kogan, Singh, Dee, \& Grummer-Strawn, 2011). For example in Australia a high initiation rate of 92% was found for EBF from 2004 to 2005 , this rate then dropped to 71% of infants who exclusively breastfed at 1 month of age, 56% at 3 months, and 14% at 6 months (Akca, et al., 2017). Similarly, in Jordan, findings from a recent research study indicate that 51% of infants began EBF within 24 hours, falling to 47% at 1 month of age, and 33% at 6 months (Khasawneh \& Khasawneh, 2017).
Significance of the study 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).
METHODS Design 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.
Hypothesis 1- The primary hypothesis of the proposed study is: The EBF rates in the intervention group during the 6 months after delivery will increase 2- fold that of the control group.
- The secondary hypotheses are: Receiving breastfeeding promotional text messages will result in higher appropriate infant feeding practices in the intervention group compared to that of the control group.
Setting The study will be conducted at Al-Karak hospital the main governmental and teaching hospital in the southern region of Jordan. In 2016 the hospital reported that on average 2,808 births occurred, 59% were caesarean births (Ministry of Health, 2017). In this hospital, there is a higher possibility of recruiting women from a diverse range of socioeconomic backgrounds. The hospital is accredited as a baby friendly hospital initiative and follows guidelines to provide early initiation of breastfeeding. The hospital has a policy to encourage mothers to give colostrum to babies within 1 hour after birth regardless of the type of delivery.
Study population Inclusion criteria will be mothers who (1) are 18 years of age and older, (2) speak and write in Arabic language, (3) could access a mobile phone that could display Arabic language fonts,(4) express interest in breastfeeding, (5) had an uncomplicated singleton pregnancy, and who lived in an area with mobile network coverage. Exclusion criteria will be (1) Non-Arabic speaking mothers, (2) who do not express interest in breastfeeding, (3) had pregnancy complications, a multiple pregnancy, and known medical conditions including mental illness that might hinder breastfeeding.
Recruitment, Assignment, and Allocation Participant eligibility will be accessed via a hospital attendance registry (used by hospital staff) in which information such as age, address, and phone numbers are recorded. At recruitment, researcher will identify potential participants with the help of hospital nurses, explained the study, provided an information statement and consent form written in Arabic, and confirmed eligibility. If a mother agreed to participate, informed consent will be obtained, and she will be requested to complete the baseline survey questions. The participant's mobile phone will be checked for compatibility with text messages and, if needed, brief training on how to read text messages will be provided.
Eligible mothers will be randomized to the intervention or control group according to an allocation sequence that will be generated by the researcher using a computer program. Each study and group number will be kept in an opaque envelope to conceal the allocation sequence and securely stored. At recruitment, researcher sequentially will take an envelope for each consenting participant and conducted the baseline interview to collect baseline data. After the participant's information is recorded, the envelope will be opened and the group allocation will be recorded.
Blinding Because the intervention could not be blinded, bias will be minimized by ensuring both groups received messages and by not explaining in the consent and information sheets how the text messages differed between groups. The information statement that will be provided only general information that each participant could be allocated randomly into a group; will receive messages containing information on childcare, and breastfeeding practices; and that the frequency of messages could vary from 1 to 3 times per week. Research staff and interviewers (via telephone) will be blinded to each participant's group status although they might guess the group based on participants' responses. To minimize bias, we will also blind research staff to the trial aims and hypotheses.
Sample size Sample size was calculated with median effect size, 95% power, 5% alpha, and 25% expected loss at follow-up. The estimated sample size is 210 (105 per group) and the final sample size requirement will be 260 participants to allow for 25% loss at follow-up, 130 each group.
Data collection Baseline data will be collected from mothers during recruitment. Follow-up (outcome) data will be collected by monthly phone calls at 1 to 6 months post delivery.
Baseline Data Collection
- A structured form (appendix 1) will be use to collect baseline data prior to discharge, participants will be asked to provide information on their socioeconomic status, previous pregnancies and breastfeeding history, knowledge and sources of breastfeeding information, intention to breastfeed, and intended breastfeeding patterns.
- Also information on childbirth outcomes will be collected including type of delivery and the newborn's birth weight, sex, and perinatal outcomes.
- Breastfeeding self efficacy will be assessed before discharge using the Arabic version breastfeeding self-efficacy scale(C. L. Dennis, 2003). The short form of the instrument, the BSES-SF, which was developed by Dennis, retains only 14 of the original 33 items and has also been shown to be a reliable (Cronbach's alpha coefficient was 0.94) and a valid measure of breast-feeding self-efficacy and to predict breast-feeding initiation, duration, and exclusivity (C. L. Dennis, 2003). The BSES-SF is made up of 14 items based on 5-point likert scale, where the mothers respond to each of the statements by checking a number from 1 to 5, whereby 1 denotes "not at all confident" and 5 denotes "very confident". All items are presented positively and begin by the idiom "I can always".
Follow-Up Data Collection Follow-up data collection will comprise feeding follow-up assessments, morbidity, breastfeeding self-efficacy Scale.
- The feeding follow-up form (appendix 2) will be completed every month and asked if the infant is breastfed and if other liquids or foods were given in the last 24 hours and over the preceding month since the last contact (or birth for the first follow-up). Each participant will complete 6 assessments of their feeding practices, including detailed information about the different types of liquids and foods.
- Child morbidity status (appendix 2) will be assessed when the child is 1, 3, and 5 months of age using a structured form. Child morbidity questions (ref) will be used to record whether the child has had any signs or symptoms such as fever, cough, cold, running nose, rapid breathing, and difficulty in breathing, chest in drawing, and diarrhea and dysentery. If one of these was present, duration of illness will be further explored
- Breastfeeding self-efficacy will be collected at 1, 3, and 5 months post delivery to ascertain the mothers' confidence to breastfeed, the relationship between self-efficacy and breastfeeding duration, and whether text messages improved breastfeeding self-efficacy.
Outcome Measures The primary outcome is the rate of EBF at 1 to 6 months of the infants' age measured at monthly intervals after delivery. Secondary outcomes are median duration of EBF and rates of early initiation of breastfeeding (within 1 hour after birth); predominant breastfeeding; current breastfeeding; bottle feeding; and early introduction of solid, semisolid, or soft foods at 1 to 6 months of infant's age (measured at monthly intervals).
Data analysis Outcomes will be compared between groups using t-test for parametric data and Wilcoxon rank sum for nonparametric data.
Ethical consideration Approval to conduct the study will be obtained from the ethics committee at faculty of nursing / Mutah University and the Ministry of Health (MOH). Mothers will be informed about the study and verbal and written consent for agreement will be obtained from each mother . Mothers will be assured that participation is voluntary and they have the right to withdraw from the study at any time without giving any reason. Mothers will be assured that their information will not be recognized in any products of this research. Data will be stored on computer and accessed only by the principal investigator.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: promotional Exclusive breastfeeding text messagesThe intervention group will receive EBF promotional messages from the time of discharge until 6 months post delivery. |
| control | Other | Other: promotional Exclusive breastfeeding text messagesthe control group will receive child health care-related messages (except breastfeeding messages) from the time of discharge until 6 months post delivery. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| promotional Exclusive breastfeeding text messagespromotional Exclusive breastfeeding text messages will be send to women via mobile phone | Other | control, intervention |
Primary outcome
The rate of the Exclusive Breastfeeding
Time frame: from birth of baby to 6 months post birth
The primary outcome is the rate of EBF at 1 to 6 months of the infants' age measured at monthly intervals after delivery
2 secondary outcomes
median duration of EBF
Time frame: from birth of baby to 6 months post birth
rates of early initiation of breastfeeding
Time frame: within 1 hour after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Background: PubMed 23484776Abuidhail 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.
- Background: PubMed 22864059Ahmed 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.
- Background: PubMed 28303340Akca 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.
- Background: PubMed 24422991Al 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.
- Background: PubMed 28469519Alzaheb RA. Factors Influencing Exclusive Breastfeeding in Tabuk, Saudi Arabia. Clin Med Insights Pediatr. 2017 Mar 10;11:1179556517698136. doi: 10.1177/1179556517698136. eCollection 2017.
- Background: PubMed 29406289Araban 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.
- Background: PubMed 18507601Dennis 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.
- Background: PubMed 14649593Dennis 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.
- Background: PubMed 24812071Flax 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.
- Background: PubMed 25369808Gallegos 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.
- Background: PubMed 24639004Jiang 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.
- Background: PubMed 22123898Jones 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham M Khresheh, PhD principal investigator
Mutah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing promotional Exclusive breastfeeding text messages in people with Breastfeeding, run by Mutah University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of the Exclusive Breastfeeding (time frame: from birth of baby to 6 months post birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890978, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.