Definitions

Structured questionnaires were developed and adapted from the literature [23, 24] as well as from prior work in the participating countries [25–27]. Prelacteal feeding was defined as any non-breast milk feeds given within the first three days after birth. The women were asked if the baby was given 1) any mouthfuls to drink other than breast milk within the first three days after birth, and thereafter 2) any drops of something to taste. The latter was intended to capture religious or traditional practices. If they answered ‘yes’ to prelacteal feeds they were asked to answer yes or no to a predefined food list of 16 items that were identified through formative research [25]. Regarding giving or not giving colostrum the women were asked if they gave the first milk to the baby or expressed and discarded it. Initiation of breastfeeding was determined by the timing of the first breastfeed. The following cumulative categories were created based on categorical data collection: Within the first hour; within 12 hours; within 24 hours and after.

Analysis

Factors associated with the non-recommended early feeding practices prelacteal feeds and late (after 12 hours) initiation of breastfeeding were studied. The factors of interest related to the mother were: maternal body mass index, kg/m² (BMI) at six weeks; place of delivery, ‘facility delivery’ contrasting ‘home delivery’; type of delivery, ‘normal vaginal’ contrasting ‘Caesarean-section, breech or other complications’; parity; socioeconomy where the two top quintiles contrasted the 3 bottom quintiles, the quintiles were derived from multiple correspondence analysis [12, 28]; education given as years of schooling; antenatal care attendance; and the intervention package. Factors related to the child were body size and gender. The PROMISE-EBF trial did not capture birth weight, however, we asked for birth weight at the 3-week interview. In Burkina Faso, 98% could not report any birth weight, contrasting 65% in Uganda and 8% in South Africa. We therefore had limited and unreliable birth-weight data. As a proxy for size at birth, we used the 3-week anthropometric data, weight-for-length, length-for-age and weigh-for-age z-scores according to the WHO Child Growth standards [29], acknowledging the limitation that early infant feeding practices may have influenced the anthropometric status of the child at 3 weeks.

Descriptive statistics included means with 95% confidence intervals (CI), medians and ranges for continuous variables and proportions for categorical variables. For the categorical data, generalised linear models of the binomial family with a log link were used to calculate prevalence ratios (PR). This was done a) by trial allocation and b) according to a cohort design where statistically significant factors associated with the outcome at the p <0.05 level, socio-economic and the trial allocation went into the multi-variable models. Analysis was done by country and all presented data were adjusted for the design effect by having randomized clusters rather than individuals. The data were analysed using STATA 11 SE (Stata Corp LP, College Station, TX, USA).

Ethical approval

Approval for the trial (ClinicalTrials.gov: NCT00397150) was obtained from the following bodies: 1) Burkina Faso: Institutional Review board of Centre Muraz (No 013/2005/CE-CM) and the Ministry of Health at national and regional level; 2) Uganda: Makerere University Faculty of Medicine Research and Ethics Committee, and the Uganda National Council for Science and Technology; 3) South Africa: Ethics Committee of the Medical Research Council South Africa; and 4) Norway: Regional Committees for Medical and Health Research Ethics (REK VEST), 8 Sept 2005, issue number 05/8197. Women provided verbal informed consent for participation in the peer-counselling programme, which was regarded as a service. Written informed consent for participation in the study was signed or thumb-printed by each respondent.

Population

2579 mother-infant pairs were enrolled in the study in the three countries: n =794 in Burkina Faso, n =765 in Uganda and n =1020 in South Africa. Two publications [12, 22] provide exact details on baseline characteristics in the trial by country and trial allocation, indicating a fairly successful randomisation and highlighting huge country variations particularly in socioeconomic and education levels where Burkina Faso is the poorest and South Africa the least poor among the three. The majority were seen at the 3-week visit: 729/794 (91.8%) in Burkina Faso, 731/765 (95.6%) in Uganda and 951/1020 (93.2%) in South Africa for the early infant feeding recall. A small proportion was interviewed for the early infant feeding recall at 6 weeks and at 12 weeks, respectively: Burkina Faso: 47/794 (5.9%), Uganda: 25/765 (3.3%), South Africa: 49/1020 (4.8%) and Burkina Faso: 18/794 (2.3%), Uganda: 3/765 (0.4%), South Africa: 14/1020 (1.4%). The median, days, (percentile, p, p25-p75) recall time for prelacteal feeds were 22 (19-25) in Burkina Faso, 22 (21-24) in Uganda and 24 (21-30) in South Africa.

Prelacteal feeds and drops or religious feeds

Colostrum

The majority in all three countries gave colostrum to their babies (Table 1). There were no substantial or statistical significant differences between women in the intervention and control groups regarding this behaviour in Burkina Faso or South Africa, but in Uganda, those in the intervention group discarded colostrum less frequently (3%) than those in the control groups (10%), PR 0.3 (95% CI 0.1, 0.6).

Initiation of breastfeeding

Only a minority in Burkina Faso (<4%) and roughly half in South Africa initiated breastfeeding within the first hour with no substantial or statistically significant differences between the intervention and control groups. In Uganda the women initiated breastfeeding early to a slightly larger extent than in the other two countries, and women in the intervention group even more so than in the control group (Table 1).

Factors influencing early infant feeding practices

Caesarean section or complicated delivery was a risk factor for late initiation of breastfeeding in all three countries. Further, delivery in a facility was associated as a protective factor in Burkina Faso and South Africa. Being multipara was only associated with early initiation of breastfeeding in South Africa, as well as receipt of the intervention and higher socioeconomic ranking in Uganda.

Differences and challenges in the peer counselling intervention in the three different countries

A post-intervention study in Uganda described that the mothers expressed satisfaction with the intervention [31] and a tendency towards the peer counsellor evolving from teacher to friend during the study period. The mothers expressed satisfaction with the taught content and expressed a desire to continue themselves as peer counsellors. The mothers reported an appreciation of culturally-sensitive behaviour change messages. One limitation with our knowledge about this intervention in Uganda was the researcher’s involvement in the intervention implementation and lack of external evaluation [19, 31]. This could in a way have led to under reporting of problems; however, this role was carefully reflected upon [32]. A described strength of the implementation in Uganda and Burkina Faso was that the teams involved the communities to a high degree, also in the selection of peers [19, 33].

In South Africa cultural issues were far more challenging [20] and the peers struggled much more to get acceptance. The peer supporters required substantial supervision and follow-up from their respective trainers and supervisors. Issues like no previous job experience, own health problems, emotional stress through fear and rejection, safety issues and HIV disclosure issues among study mothers were of far greater concern in the study than the intervention itself [21]. In other words, the South African peer supporters expressed a need for far deeper and more comprehensive understanding for themselves, combined with supervision and follow-up. With South Africa’s high HIV prevalence, it could be argued that a community intervention alone without intervening at facility-level was not enough to alter behaviour. However, we report findings from the HIV-negative and breastfeeding intending South African women in this paper so HIV as such cannot explain all the challenges this intervention had in South Africa. Furthermore, the counsellors were not recruited from the communities in the same way as in Burkina Faso and Uganda, thus, did not provide the same sense of community belonging. They were geographically from the respective cluster area, but recruited in a more formal manner through advertisements and interviews which is the regulated way to identify and appoint personnel.

The issues related to the country specific implementation of the intervention might explain some of the variation between the countries. However, this study suggests that large country variations in feeding were present from birth. For example, it is known that formula feeding had a high acceptance in South Africa [34], whereas this is not the case in Uganda and Burkina Faso and large areas of sub-Saharan Africa where it is considered unaffordable, unacceptable and unfeasible [35]. Women in Burkina Faso and Uganda might thus have been more motivated to breastfeed than in South Africa. Another country difference is that Burkina Faso has less access to and use of maternity facilities and lower general educational level, thus, this might explain why e.g. traditional practices illustrated by e.g. delaying and giving drops and syrups to the child had a high uptake there. This understanding was also supported from parallel research within the prevention-of-mother-to-child transmission of HIV (PMTCT) research [36]. Thus, timing of initiation of breastfeeding did not improve substantially in this trial, and the community-based intervention was not sufficient to get an effect on the timing of breastfeeding in Burkina Faso.

Prelacteal feeds and drops or religious feeds

We presented the relationship between prelacteal feeds and drops or religious feeds. There was a strong relationship between these two practices in all three countries. However, smaller babies in Burkina Faso and South Africa got more prelacteal feeds that may indicate that mothers believed their babies needed this to a larger extent.

Colostrum and initiation of breastfeeding

In contrast to the other two countries a behaviour change was seen from the intervention in Uganda related to colostrum and initiation of breastfeeding, though, relatively moderate. Mothers in the intervention group were more likely to give colostrum to their babies in comparison to control cluster mothers. This could serve as an indication for earlier behaviour change in Uganda compared to the other countries as mentioned [31], and that they perceived and recognised the recommendation “immediate” and “exclusive” in this setting. In line with our study, comprehensive and integrated counselling strategies have been described as very successful in changing behaviour and health outcomes, as was the case from a large trial in Haryana, India [37, 38]. Further, subjective intrinsic factors determining behaviour change are deeply embedded in cultural norms and traditions, thus understanding context of relevant barriers related to self-efficacy, beliefs and attitudes is key to meet and counsel the women in a meaningful way [38, 39]. Our study group addressed some of these factors in formative research identifying poverty and limited access to health systems facilities, water, sanitation and fear of stigma and rejection as key factors why not breastfeeding is considered a non-option in Burkina Faso and Uganda [33, 40]. In a way in these two countries, breastfeeding was already an established norm, and the trial had to address the question whether “breastfeeding was really enough.” The peer-intervention training package provided enough essential information on stimulation and production of breast milk to address this [31].

The usefulness of theory to inform and guide health behaviour interventions cannot be underestimated. While the intervention was not planned and implemented using a specific theory a priori, the intervention has been described [32] according to Kok and colleagues’ work [41] on Intervention Mapping: The theory describes a flow for implementation originating from proximal programmes through the development of strategies, programme plans, adaption and evaluation. This flow is implying certain consecutive tasks. In our case the initial step was the WHO course which was adapted by the research team and through local knowledge (research team in collaboration with the communities) moderated and operationalised. However, this process was not uni-linear, but involved substantial feedback options through interaction and pre-testing [19, 32, 42].

Strengths and limitations

This analysis is based on self-reported, not observed, early infant feeding practices, hence there is the potential for information bias. However, the high number of women reporting prelacteal feeds in the intervention group (12%, 15% and 25% in Burkina Faso, Uganda and South Africa, respectively) might indicate that these questions were well understood and responded to. The PROMISE-EBF trial did not capture birth weight, however, we asked for birth weight at the 3-week interview. Using 3-week anthropometric information as a proxy for birth weight is a limitation because, our outcome of interest, early infant feeding, happened in real time before the measurements. This study does not allow us to investigate any relationship between early severe events such as neonatal death or hospitalisation due to a) sample size limitations; and b) limitation in study design resulting in healthy live children being enrolled in the follow-up where the early infant feeding questions were asked. However, studies on peri- and neonatal mortality exist from the cohort of pregnant women enrolled from both Burkina Faso and Uganda without reporting on early infant feeding practices, while indicating associations between severe outcomes (death) and place of delivery and parity in Uganda and Burkina Faso, respectively [43–45].