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Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269 and * Department of Nutrition and Food Science, University of Ghana, Legon, Ghana
3To whom correspondence should be addressed. E-mail: bchinbus{at}yahoo.com.
| ABSTRACT |
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KEY WORDS: exclusive breast-feeding lactation counseling Hawthorne effect Ghana
Breast-feeding (BF)4 has various beneficial effects including enhancement of the infants immunity, protection against gastrointestinal and respiratory infections, reduction in maternal hemorrhaging, and reduction in the risk of breast and ovarian cancer (15). In contrast to developed country settings, almost all mothers initiate BF and BF durations are longer in developing countries (6,7). In Ghana, for example, the median BF duration is 22 mo and 53.4% of women with children <6 mo breast-feed exclusively (8). Despite high BF rates, exclusive breast-feeding (EBF) rates remain low in many developing countries (7,9). Complementary feeding practices vary substantially across regions, and include the addition of liquids, porridges, and semisolid foods to the infants diet very early in life. This has been associated with a high rate of diarrhea (2,3,5), a common cause of infant mortality. For these reasons, the WHO has recommended EBF to 6 mo (10,11).
To be able to achieve the WHO EBF goal, it is important to understand the factors that influence EBF and how best to promote this behavior. Various studies have investigated the effect of breast-feeding education/support on initiation and duration; although most show positive results (1218), a few have not (1922). The justifications for our study are as follows: 1) although several randomized controlled trials (RCTs) were conducted over the past decade (1316,18), none were conducted in sub-Saharan Africa where EBF is essential to improve infant health; 2) RCTs varying the timing of intervention (i.e., starting prenatally versus perinatally) are lacking; and 3) none of the studies reported so far controlled for the Hawthorne effect, which refers to "the tendency of study participation per se to affect the outcome" (23). Thus, there is the possibility that at least part of the intervention effects may be explained simply by the contact with counselors and not necessarily by the content of the intervention. We expect lactation counseling findings in urban Africa to differ substantially from those in urban Latin America (16) because the breast-feeding culture and complementary feeding practices differ substantially. Although these differences are not as marked between Bangladesh (15) and Ghana, the RCT in Dhaka to which we compare our results was based on a population that delivered primarily at home (15). Thus the objectives of this RCT were to determine: 1) the effect of lactation counseling on EBF rates after controlling for the Hawthorne effect, and 2) the timing of EBF support that would be most effective in improving EBF rates among Ghanaian mothers delivering in urban hospitals.
| SUBJECTS AND METHODS |
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30 km east of Accra, the capital of Ghana. The municipality covers a geographic area of 35,959 km2. Subjects resided in Tema township (population: 141,479) or in Ashiaman (population: 150,312) (24). The former is an industrial city and is the administrative capital of the Tema municipality, whereas the latter is a commercial town.
Study design.
This was an RCT designed to measure the effect of lactation counseling on EBF behaviors. The subjects were pregnant women recruited from prenatal clinics in 2 hospitals (1 government and 1 private) in Tema Township. The study was approved by the Institutional Review Board of the University of Connecticut, and consent was given by the authorities of the 2 Ghanaian hospitals. Subjects were recruited from May to September 2002, using a 2-stage screening process. An initial screening of pregnant women took place during their prenatal visit; upon delivery, a second screening took place to ascertain whether both mother and infant qualified for inclusion. Pregnant women in their last trimester of gestation, planning to deliver in the selected hospitals and to stay in Tema or Ashiaman for at least 6 mo after delivery, were included. On delivery, term infants (3644 wk gestation) who were singletons, with normal birth weight (
2500 g) and APGAR scores
6 at 1 and 5 min, were included.
Informed consent was obtained from pregnant women who qualified to be part of the study after the initial screening process. They were subsequently asked to respond to a 30-min baseline interview to provide data on demographic, socioeconomic, and biomedical factors, BF support obtained previously and for the current pregnancy, planned infant feeding practices for the current pregnancy, and previous infant feeding behaviors among multiparae. After the baseline interview, pregnant women were randomly assigned to 1 of 3 groups: 2 intervention and 1 control. Randomization was achieved by writing numbers 1 to 3 on folded pieces of paper. The numbers were not viewed by either study staff or mothers and the pieces of paper looked the same on the outside. Before offering the papers to mothers, they were shuffled in the interviewers palm. Each mother then picked 1 paper to determine her group allocation. The specifics about each groups intervention were not discussed with participants.
Study groups and follow-up schedule. To control for the Hawthorne effect, participants in all groups, including the control, had 2 education sessions during the prenatal stage and subsequently received 9 home visits from counselors during the 6 mo postpartum period. Home visits were made at 1, 2, 4, 6, 8, 12, 16, 20, and 24 wk postpartum. The content of the educational sessions and support given depended on the group to which the mother was assigned. Intervention group 1 (IG1, n = 74) mothers were provided with BF and EBF education from the prenatal stage onward. Intervention group 2 (IG2, n = 72) mothers were provided with BF and EBF education from the perinatal period (within 48 h postpartum) onward. Control group (C, n = 85) mothers were provided in both periods with education on other health-related topics but not on breast-feeding. Women were given the prenatal education in groups of 24, with a duration of 20 min for each session. Women were informed only that they would receive "health education" that would be beneficial to their infants and themselves, but were not aware of their group allocation or of differences in the content of the health education.
The study recruited 231 eligible women. Of these, 95 were excluded for the following reasons: failure to return to study hospitals (n = 29), delivering elsewhere (n = 15), missed on delivery (n = 5), low birth weight or low APGAR scores (n = 33), moving out of study areas (n = 11), no time to attend prenatal educational session (n = 1), and maternal death (n = 1). Of the 136 eligible mother-infant pairs, 123 (90.4%) completed the 6-mo home follow-up (Fig. 1). Those lost to follow-up were less likely to own a TV set (61.5 vs. 88.6%) and more likely to be without formal education compared with those who completed the study (23.1 vs. 4.1%, respectively). There were no significant between-group differences in sociodemographic factors or breast-feeding plans at baseline (Table 1).
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For the control group, most of the topics discussed were from booklets and handouts prepared by Ghanas Ministry of Health. Topics covered included: immunizations for the first 2 y, iodine deficiency disorders, family planning, cholera, measles, and HIV/AIDS. Control group mothers were directed to the postpartum child welfare clinics for answers to BF-related questions. At the last scheduled home visit at 24 wk, all mothers, irrespective of group allocation, were educated on complementary feeding practices and were advised to use family planning as a child-spacing tool.
Counselors. Counselors used for the study were 2 local nurses and 1 nutritionist. They had all successfully breast-fed at least 1 child. Health personnel were chosen because they were highly regarded in the communities as a credible source of health information. It was impossible to keep counselors unaware of the study design and group allocation of mothers because this information was crucial for them to determine what type of "health education" to provide during the counseling sessions. A certified lactation consultant trained the counselors for 1 wk using the WHO/UNICEF BF counseling training manual (25). Training included both classroom work and hands-on practice with mother-infant pairs in a hospital. Emphasis was placed on the following topics: why EBF is important, how BF works (BF physiology), assessing BF episodes (e.g., responses of baby to breast, suckling, feel of the breast after feeding), positioning and attachment of baby to the breast, taking a BF history, manual expression of breast milk, effective counseling to build confidence and give support, listening and learning skills, counseling mothers in different situations (e.g., after caesarean section), and breast conditions (e.g., flat/inverted nipples, engorgement, sore nipples).
Data collection. Two research assistants, who were different from the counselors, were trained to conduct baseline, perinatal, and home interviews and take infant anthropometric measurements on a monthly basis. At the home, data were collected on onset of lactation, lactational amenorrhea, current BF status, total number of breast-feeds over the past 24 h, postpartum BF advice or support, infant morbidity and anthropometry, mothers working status and proximity to infant while at work, recall of liquid or semisolid foods introduced to the infant over the previous month and the past 24 h, and frequency and age of introduction of specific liquids or foods and reasons for their introduction. A schedule was considered missed if the mother could not be reached after 2 wk of trying. Research assistants were aware of the mothers group allocation at the pre- and perinatal stage because they were involved in the initial assignment of mothers to their specific groups and were responsible for reporting the group allocation of a mother to counselors on delivery. However, questionnaires used were uniform for all groups and did not have any section for recording subjects group. Thus the only way for them to be aware of a mothers group during the 6-mo postpartum period was if they recalled this information from the pre- or perinatal stage.
Statistical analyses.
SPSS for Windows® software was used for data entry (Version 6.0) and analysis (Version 11.5). Characteristics of the 3 groups at baseline were compared using ANOVA and
2 analysis. The main outcome for the analyses was EBF (yes or no). Three EBF variables were used based on whether the child received no food or liquid in 3 time periods: 1) over the previous month, 2) over the 24 h preceding the day of the monthly interview, and 3) over the entire 6-mo period (this was deduced from answers to the first 2 variables). If an infant received no food or liquid over the "24 h" preceding the monthly interview and also during the "previous month," for the entire 6-mo data collection period, he/she was considered as having been exclusively breast-fed since birth. If a mother was missed during a data collection visit between mo 1 and 6, she was still included in the analyses for EBF "24 h" and EBF "previous mo," but was included in the analysis for EBF "since birth" only if she was available for the final 6-mo interview.
2 analysis was used to determine significant between-group differences in categorical sociodemographic and biomedical factors, as well as in EBF rates across time. Between-group differences in planned BF and EBF, and past BF and EBF duration were analyzed using one-way ANOVA. Differences were considered significant at P < 0.05. To determine counselors compliance from respondents report, respondents were asked at each monthly data collection visit whether they had received BF advice and if so, by whom.
| RESULTS |
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About 63% of IG1, 73% of IG2, and 65% of C mothers received all 9 scheduled home follow-up visits. Almost all women across groups received at least 6 of the 9 scheduled visits with no between-group differences in total number of visits. The total visit duration for the entire 6-mo follow-up period was 239 min for IG1, 253 min for IG2, and 229 min for C. The corresponding mean duration for each home visit was 29, 30, and 22 min, respectively.
EBF practices. Significant between-group differences were found in "previous mo" EBF from mo 3 to 6. In IG1, "previous mo" EBF tended to increase across time, with some fluctuations, starting from 69% in mo 1 to 90% at mo 6 (Fig. 2). Similarly, "previous mo" EBF increased in IG2 from 74.4% in mo 1 to 92.3% in mo 4, and then declined to 74.4% in mo 6 (i.e., the same prevalence as in the mo 1). The "previous mo" EBF in C fluctuated from 57.4% in mo 1 to 64.6% in mo 2 but thereafter decreased to 47.7% in mo 6 postpartum (Fig. 2).
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| DISCUSSION |
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A possible explanation for the high rates of EBF at 6 mo in the intervention groups in the trials in Ghana and Bangladesh (15) is that nonexclusive BF in these settings usually involves feeding of nonmilk-based fluids rather than the milk-based or energy-dense semisolid complementary foods used in Latin America (7). Indeed, in sub-Saharan Africa and South Asia, a major problem is the late introduction of energy- and nutrient-dense complementary foods before infants are 9 mo old (7). Thus, it is likely that in the Mexico City trial, the challenge was not only to prevent the use of water-based supplements but also to convince mothers to avoid the use of milk-based and energy-dense semisolid supplements, and to not wean their infants from the breast.
In this study, findings on intervention effect were very consistent regardless of the EBF definition used. This was not surprising because the correlation between the "previous 24 h" and the "previous mo" definitions was high (range: 0.720.90, P < 0.001 across time). This confirms that either EBF definition can be used for understanding EBF determinants (28) even though EBF absolute prevalence estimates would vary.
The fact that IG1 (prenatal, perinatal, and postnatal BF counseling) and IG2 (perinatal and postnatal BF counseling) mothers had similar EBF rates does not imply that prenatal BF education is not needed. This study was conducted during a period in which EBF promotion had been ongoing in the hospitals and clinics in Ghana. A previous exploratory study in Ghana showed that 98.1% of women attending child welfare clinics had heard about EBF (28). Indeed one of the study hospitals (Tema General Hospital) intensified BF promotion during the period of recruitment in preparation for an assessment to be a Baby Friendly Hospital. This hospital has since been declared Baby Friendly. This implies that prenatal BF education provided by personnel other than those involved with this study was adequate. In the current study, women in IG2 were seen within 48 h after delivery and were provided with the needed BF education and support, which continued through 6 mo postpartum. Thus, there was not much difference between the IG1 and IG2 groups. The implications are that in the present setting, it is crucial to maintain the existing hospital/clinic prenatal BF education and provide additional BF support within the perinatal period and through 6 mo postpartum to increase EBF rates. The role of additional prenatal BF education should be studied in different contexts because it is quite possible that it may be crucial for EBF success in communities with weak prenatal EBF education and support.
Limitations of our study are that first, the design does not allow us to determine whether there was an effect of general counseling or repeated contact with research personnel (i.e., Hawthorne effect) because we did not include a group that had no contact with study personnel during the follow-up period. However, our design does allow us to rule out the possibility that the observed increase in EBF rates in the intervention groups was due simply to continued contact or the Hawthorne effect. This is important for public health policy because it suggests that content focused on EBF and not just the amount of contact with health educators is crucial for promoting EBF in Ghana. Second, the randomization scheme used was not a formal one. It was one that could be conducted easily in the field. Despite this, it functionally produced balanced groups with no evidence of bias. Third, EBF was self-reported; thus we cannot rule out the possibility that women in the peer counseling group may have been influenced by social desirability bias. However, this is unlikely because the staff delivering the intervention were different from the staff collecting infant feeding data. In addition, home interviews were unannounced and included a thorough visual inspection of any infant feeding items or utensils that may indicate that exclusive breast-feeding was unlikely (e.g., formula cans, bottles). On the rare occasion when such discrepancies were found, women were told that they should feel free to report the true feeding status of the infant. The lack of a more objective measure of exclusive breast-feeding is a limitation not only of this but also of previous randomized studies in this area (15,16). This indicates the need to develop biomarkers that can be detected in infants urine, saliva, and/or feces that can be easily applied under field conditions to confirm EBF reports. Fourth, the lack of influence of prenatal support on EBF should be interpreted with caution because the women who dropped from the study were of lower socioeconomic status.
We conclude that in populations with a strong BF culture, lactation counseling, if well done, can have a substantial effect on EBF. Our study suggests that the almost doubling in EBF rates attributed to the intervention is likely to have major maternal and child health implications in Ghana (11). Thus, the Ghanaian government should invest in adequate EBF training for counselors that seek to improve this behavior. It is important that we move from efficacy to cost-effectiveness trials to determine whether the high level of counselor contact used in this study is affordable or whether less intensive models are needed.
| ACKNOWLEDGMENTS |
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| FOOTNOTES |
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2 Funded by the University of Connecticut Research Foundation and LINKAGES USAID. ![]()
4 Abbreviations used: BF, breast-feeding; C, control group (provided with nonbreast-feeding health educational support); EBF, exclusive breast-feeding; IG1, intervention group 1 (EBF support given pre-, peri-, and postnatally); IG2, intervention group 2 (EBF support given peri- and postnatally); RCT, randomized controlled trial. ![]()
Manuscript received 29 November 2004. Initial review completed 3 January 2005. Revision accepted 21 April 2005.
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