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Background: Exclusive breastfeeding (EBF) improves infant health and survival. We tested the effectiveness of a home-based intervention using Community Health Workers (CHWs) on EBF for six months in urban poor settings in Kenya. Methods: We conducted a cluster-randomized controlled trial in Korogocho and Viwandani slums in Nairobi. We recruited pregnant women and followed them until the infant’s first birthday. Fourteen community clusters were randomized to intervention or control arm. The intervention arm received home-based nutritional counselling during scheduled visits by CHWs trained to provide specific maternal infant and young child nutrition (MIYCN) messages and standard care. The control arm was visited by CHWs who were not trained in MIYCN and they provided standard care (which included aspects of ante-natal and post-natal care, family planning, water, sanitation and hygiene, delivery with skilled attendance, immunization and community nutrition).CHWs in both groups distributed similar information materials on MIYCN. Differences in EBF by intervention status were tested using chi square and logistic regression, employing intention-to-treat analysis. Results: A total of 1110 mother-child pairs were involved, about half in each arm. At baseline, demographic and socioeconomic factors were similar between the two arms. The rates of EBF for 6months increased from 2% pre-intervention to 55.2% (95% CI 50.4-59.9) in the intervention group and 54.6% (95% CI 50.0-59.1) in the control group. The adjusted odds of EBF (after adjusting for baseline characteristics) were slightly higher in the intervention arm compared to the control arm but not significantly different: for 0-2months (OR 1.27, 95% CI 0.55 to 2.96; p=0.550); 0-4months (OR 1.15; 95% CI 0.54 to 2.42; p=0.696), and 0-6months (OR 1.11, 95% CI 0.61 to 2.02; p=0.718). Conclusions: EBF for six months significantly increased in both arms indicating potential effectiveness of using CHWs to provide home-based counselling to mothers. The lack of any difference in EBF rates in the two groups suggests potential contamination of the control arm by information reserved for the intervention arm. Nevertheless, this study indicates a great potential for use of CHWs when they are incentivized and monitored as an effective model of promotion of EBF, particularly in urban poor settings. Given the equivalence of the results in both arms, the study suggests that the basic nutritional training given to CHWs in the basic primary health care training, and/or provision of information materials may be adequate in improving EBF rates in communities. However, further investigations on this may be needed. One contribution of these findings to implementation science is the difficulty in finding an appropriate counterfactual for community-based educational interventions. Trial registration: ISRCTN ISRCTN83692672. Registered 11 November 2012. Retrospectively registered.
The study protocol is already published [17]. For this paper we only detail methods relevant to the research question. The study was carried out in two slums of Nairobi, Kenya (Korogocho and Viwandani) where the African Population and Health Research Center (APHRC) operates the Nairobi Urban Health and Demographic Surveillance System (NUHDSS), covering close to 70,000 residents. The two slums are densely populated with roughly 60,000 inhabitants per square km and are characterized by poor housing, lack of basic infrastructure, violence, insecurity, high unemployment rates and poverty, food insecurity and poor health indicators including poor IYCN practices, high levels of malnutrition and mortality [14, 18–22]. This was a cluster randomized controlled trial [23]. Randomization of the community units (CUs) to the intervention or control arm was computer-generated by a data analyst who was not a primary member of the study team. (A CU as defined by the Kenyan Community Health Strategy is geographically defined with an approximate population of 5000 people. Where the CUs did not exist, APHRC facilitated their set-up). Before randomization, clusters were stratified by slum of residence and the number of women of reproductive age in each cluster (large or small clusters). Fourteen CUs, eight in Korogocho and six in Viwandani were equally randomized into either intervention or control arm. Cluster randomization was preferred over individual-level randomization in order to minimize contamination and for pragmatic purposes as CHWs work in clusters. Figure 1 illustrates the outcome of the randomization process. Randomization of Study participants to Intervention and Control Groups, MIYCN Study, Nairobi Slums. 1Excluded or dropped due to loss to follow-up during pregnancy due to migration or death of mother, giving birth before receiving the intervention and pregnancy loss (miscarriage/abortion or still birth). 2Lost to follow up after giving birth due to migration, or death of mother or the baby Participants were recruited from any pregnant girls and women aged between 12 and 49 years, who were resident within the defined study area. Girls aged 12–14 years were included because close to 10% of girls below 15 years are sexually active, and from the qualitative work in the study areas young women reported that they need MIYCN counselling [16, 24]. The exclusion criteria were: (a) recruited women who gave birth before receiving the intervention; (b) women with disability that would make delivery of the intervention difficult e.g. intellectual impairment, or who bore a child with a disability that would make feeding difficult; (c) women who lost the pregnancy and/or had a still-birth after being recruited in the intervention; and (d) pregnant women who were lost to follow-up before they delivered. Efforts to recruit all eligible women were made by using the routine NUHDSS rounds complemented by use of key community informants. All known pregnant women were invited to participate in the study. The target was to recruit the women as early as possible during pregnancy. After obtaining written informed consent, recruitment was done by the data collectors on a rolling basis from September 2012 to February 2014 until the desired sample size was achieved. The sample size calculation took into account clustering of women in the CUs. A minimum sample size for both intervention and control arms of 196 was estimated to have enough power to detect an increase in EBF for six months from baseline rate of 2% in the study setting [15] to 12%. We used a significance level of 5% and power of 80%. We adjusted for expected intra-cluster correlation (ICC) using a design effect of 3.2 based on an ICC of 0.05, according to previous research in the study area [25]. Allowing for a 20% potential attrition, the sample size of 780 mother-child pairs was estimated. To increase usefulness of the secondary outcomes analysis, we increased the sample size, ending up with a sample size of 1100 at the end of the follow-up. The experimental intervention involved personalized home-based nutritional counselling of women from the time of recruitment until the baby attained one year. Scheduled visits were: pregnancy – monthly until week 34, then weekly until delivery; mother and baby pairs – weekly in the first month then monthly until12 months. Frequency during the fifth month was biweekly to prepare mothers for complementary feeding. CHWs were given a visiting schedule (Appendix 3) with appropriate key messages at each visit depending on the pregnancy gestational age and age of baby. The expected number of scheduled visits were a total of 7 during pregnancy and 17 after delivery. For each visit the CHW was given a sheet detailing what information to ask for and specific message(s) to give to the mother. Nutritional counselling messages encompassed maternal nutrition, immediate initiation of breastfeeding after birth, breast positioning and attachment, exclusive breastfeeding, frequency and duration of breastfeeding, expressing breast milk, storage, handling and feeding of expressed breast milk and lactation management. It also included age-appropriate complementary feeding. Counselling was also informed by the stages of change model [26]. We did not establish or test the HIV status of participants in this study, but the CHWs in the intervention arm were trained on infant feeding in the context of HIV and were expected to incorporate this in the counselling, without establishing HIV status of the mother. Further, the CHWs were advised to counsel mothers to seek further counselling and support at the health facilities in the event they were HIV positive. To help in the adaptation of the counselling messages and to inform the design of the intervention, a qualitative study was conducted before the roll-out of the intervention [16, 17]. Additionally, consultations were held with key institutions including the Ministry of Health, UNICEF and other organizations working on MIYCN issues in the community. Intervention CHWs within the study area recruited from the Community Units in the Community Health Strategy were trained using the Community Infant and Young Child Feeding (IYCF) Counselling Package developed by UNICEF and other partners. This package has been adopted by the Kenya Ministry of Health (http://uni.cf/1QavG2g), based on the WHO IYCF integrated course [27]. Each CHW was given a copy of the counselling cards; brightly colored illustrations that depict key infant and young child feeding concepts. For the intervention CHWs, two follow up training workshops with case discussions were also done. The CHWs were also directly observed intermittently while they counselled women in the households and given feedback. CHWs in the control arm were not trained on MIYCN but were trained (through the regular government facilitated training) together with the intervention CHWs on standard care, which included ante-natal and post-natal care, family planning, water, sanitation and hygiene, delivery with skilled attendance, immunization and community nutrition. We optimized standard care by ensuring that the intended standard care happened. We therefore facilitating the government to set up Community Units where they did not exist through recruitment of CHWs into the units and offering the CHWs with basic training in order to provide standard counselling. We also provided incentives for CHVs as intended in the Community Health Strategy. Community health workers in the control arm were expected to visit the mothers according to the standard practice prescribed in the Community Health Strategy, which is defined by need, but generally about once a month per household, and usually more frequent around the time of birth. No specific schedule was given to them. All recruited pregnant women, whether in the intervention or control arm, received standard care which included counselling from CHWs on primary health care and antenatal and postnatal care and information materials regarding MIYCN. A total of 30 CHWs across the intervention and control arms were involved in the study. The CHWs in both arms were given a monthly incentive of KES 3500 (approx. USD 35), which is within the government’s approved monthly incentive for CHWs but is rarely implemented. Routine monitoring and supervision of the CHWs was conducted primarily by an Intervention Monitor, and sometimes by other members of the project team, and government officers from the community health strategy. In addition midline and endline qualitative studies involving in-depth interviews and focus group discussion with mothers and CHWs were done among both intervention and control group. An outline of what was given to intervention vs. control group is given on Table 1. The main differences between the intervention and control arms were that in the intervention arm, the CHWs were given specific training on MIYCN and given counselling cards, while in the control group CHWs were not trained on MIYCN. Also, the in the intervention arm, CHWs were given a specific work schedule to follow up mothers, while no schedule was given to the CHWs in the control group. The CHVs in both intervention and control arms had at least primary level education. Intervention vs. Control Group, MIYCN Study, Nairobi Slums Interviewer administered questionnaires were used to collect breastfeeding data and information on control variables as described below. Data on breastfeeding practices were collected every two months until the infant’s first birthday. We used the WHO definition of EBF as “no other food or drink”, not even water, except breast milk for 6 months of life, but allowing the infant to receive ORS, drops and syrups (vitamins, minerals and medicines) [28]. In terms of measuring this, we used a three day recall to determine if the child had been initiated on other foods. Questions that were asked to establish exclusive breastfeeding included: (i) If the child was given anything other than breast milk in the first three days of life; then at each visit (ii) we asked if the child was given anything other than breast milk in the last three days; (iib) If yes to ii, we asked what the child was given and the age of starting the food/drink; (iii) If no to ii, we asked if the child has ever been given food/drink other than breast milk; (iiib) If yes to iii, we asked what the child was given and the age of starting the food/drink. To determine if the child was exclusively breastfed since birth, we used questions i, ii, and iii. So any mother who reported any deviation from the definition was relegated to a nonexclusive breastfeeding group. To determine at what age the child was given anything other than breast milk, we used questions i, iib, and iiib. Control variables collected at baseline and at birth (for example place of delivery) included: household food security assessed using the household food insecurity access scale (HIAS) [29], maternal demographic and socio-economic status; household wealth status; proxy for knowledge on EBF defined by mothers’ knowledge that foods/drinks (other than breast milk) should be introduced at six months, and no pre-lacteal feeds in the first three days of birth; and place of delivery, categorized into two: either at a health facility or other (home or TBA facility). This information is summarized in Table 2. Baseline distribution of the study participants by demographic and socioeconomic variables between intervention and control arms, MIYCN Study, Nairobi Slums a P-values are based on Chi-square that accounts for clustering bKnowledge that food other than breast milk should be introduced at six months cPlace of delivery not collected at baseline but during the follow-up We used the Chi-square test, and adjusted for the cluster study design, baseline differences to compare the proportions of mother-child pairs practicing exclusive breastfeeding (EBF) for two, four and six months The attrition rate was variable between the intervention and control groups (22% versus 17%), and to account for any potential bias from selective attrition we used logistic regression and the baseline characteristics to provide adjusted odds ratios. The cluster study design was taken into account for both the adjusted and unadjusted odds ratios. Intention to treat analysis [30] was applied as appropriate. Among those who were lost to follow-up, last observation carried forward (LOCF) was applied for those whose status as “not EBF” had been determined in the previous rounds of observation. For those whose status was not already established for any time point say two, four or six months (still exclusively breastfeeding in the last observation), LOCF was only used for the point that it was conclusively established, but was not used for latter points. Such an observation was considered as right-censored [31]. Quantitative data analysis was done using Stata version 12.1 (StataCorp LP, College Station, Texas, USA). Statistical significance was assessed with alpha = 0.05 (95% CI). Ethical approval was granted by the Kenya Medical Research Institute (KEMRI) Ethical Review Committee (Reference number: KEMRI/RES/7/3/1). Written informed consent was obtained from all participants. Proxy consent for children was obtained from their mothers.
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