Breastfeeding Clinical Trial
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.
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
1. 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.
2. Also information on childbirth outcomes will be collected including type of delivery and
the newborn's birth weight, sex, and perinatal outcomes.
3. 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.
1. 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.
2. 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
3. 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.
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