a. Study design We will use a community-based Cluster Randomized Control Trial (CRCT) to examine the impact of a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery, to improve child feeding practices, child growth and reduce the prevalence of malnutrition in their children. This will result in two study groups (see diagram). The outcome assessments will be made on a cohort of infant-mother dyads measured at baseline and at follow up visits because we expect a likely high correlation between baseline and follow up outcome measures, thus making this approach the most efficient study design.
The trial will be conducted in a total of 50 community clusters (Mahallas - smallest geographic units in Dhaka -see details below in Sampling Scheme), with 25 clusters in each study group. The peer counseling education intervention will be delivered to the mothers, by locally recruited and trained peer counsellors, starting in the third trimester of pregnancy until the child is one year of age. The peer counseling education will be offered to eligible pregnant women identified by household surveys over 3 months in each community cluster in the intervention group. Using a similar approach to recruitment, a cohort of mother-infant dyads, who will receive standard maternal and child health care programs, will be identified in the control clusters.
Outcome assessments will be conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 1950 mother-infant dyads (975 in each treatment group). There will be a baseline assessment and further assessments every 3 months from birth until the children are 18 months of age. Two of these assessments (when infant is 15 and 18 months of age) will be made after the education intervention has ceased to assess the sustained impacts on the prevalence of child stunting and infant feeding practices (see evaluation plan for details).
In this CRCT the interventions will be allocated at a community level, but the outcome assessments will be at the individual level. This is the best comparative design for the proposed interventions, which cannot be delivered to individual mothers in densely populated urban slum communities to avoid contamination of the intervention. A four year study is required to ensure an adequate "dose of the intervention" is delivered to the mothers in the intervention group, and to give time to evaluate the longer-term impact of the interventions.
b. Sampling scheme The proposed field area for the study is Mirpur, an "auxiliary Thana" in the Dhaka Metropolitan City Corporation with a total population of 5,580,000 (according to the Census 2001, although it may have increased by a further 20% to 30% since then). Mirpur has 16 "Wards" which are the smallest urban administrative unit each of which has a local government authority called a "Ward Council". The average population of a "Ward" is 350,000 people. Below the "Wards" are "Mahallas" which are the lowest urban geographic unit with identifiable boundaries. On average there are five "Mahallas" per "Ward" with an average population of 70,000 people. The unit of randomization for the trial will be Mahallas. In Mirpur there will be a total of 80 Mahallas, which will form the sampling frame for selecting the clusters in the trial. The list of these Mahallas is available from the Dhaka Metropolitan City Corporation.
The definition of the "crude birth rate (CBR) is the number of births per 1,000 population during a specified time period". The 2004 Bangladesh DHS reported a current CBR for urban Bangladesh of 25.8 per 1000 population for 3 years prior to survey. Thus the average expected number of births for each Mahallas over a 3 month period would be 150, which would be more than the required recruitment number for the trial and ensuring the feasibility of the sampling scheme for the trial.
c. Recruitment and inclusion/exclusion criteria for clusters
"Mallahas" on the sampling frame will be eligible for the study if they do not have any other infant feeding interventions currently being implemented either from the government of non-government sectors. Any such programs will be identified by contacting local officials in the Ward Councils in Mirpur. At present there are no infant feeding promotion programs run by the government health services in this area. The Dhaka Metropolitan City Corporation will be contacted in person to obtain their written approval for the study before the "Mahallas" are allocated to a treatment group or trial recruitment of subjects begins.
d. Assignment of treatments The interventions will be assigned to eligible "Mahallas" using a fixed randomisation scheme with uniform allocation ratio of treatments, and blocks of 5 or 10 to ensure geographic balance across Mirpur area. The random allocation sequence will be generated using SAS software.
e. Recruitment, inclusion/exclusion criteria and consent of mothers and their families A previously successful approach to recruitment will be used in which trained field assistants will identify women who are in their third trimester of pregnancy by systematic door-to-door surveys across the "Mahallas" over a 3 month period. Pregnant women will be included who are 16 to 35 years with no more than three living children. Women who plan to migrate from the Mirpur area after delivery will be excluded. Also women with documented medical records of heart disease, tuberculosis, gestational diabetes or eclampsia in previous pregnancies will be excluded. Mother-infants pairs will also be excluded where there are multiple births, congenital abnormalities, very low birthweight below 1.5 kg or infant admitted to a neonatal intensive care unit.
Based on experience with similar projects in Bangladesh[3,8] it is expected that at least 95% of the mothers will consent to participate. It is also likely that up to 30% will be excluded mainly related to their desire to migrate back to their home village after the delivery.
Sample Size Calculation and Outcome (Primary and Secondary) Variable(s)
The sample size for the trial was estimated with the following assumptions:
Sample size calculation for increasing the rates of exclusive breastfeeding in the intervention group
• Considering the rate of Exclusive Breast Feeding (EBF)43% in the control clusters, Bangladesh Demographic Health Survey (BDHS) 2007 and the expected rate of EBF about 63% i.e. an increase of 20% in the intervention group the required sample size will be 92.4 for each group and using formula; n= P1(100-p1) + P2 (100-p2)/(P2-P1)2 x 7.9 Taking 95 (round up the figure) and multiplying by 4 to reduce the cluster effect the sample size become 380. Calculating a 20% drop out, out migration the required sample size comes to 456 in each group to have a 0.05 significance and with a power of 0.80.
- Each community-cluster (Mahalla) has an average population of 70,000 and an expected crude birth rate of 4.3 per 1000 total population over 6 months [based on CBR for urban Bangladesh of 25.8/1000 population over 36 months from 2004 BDHS thus giving an average expected number of births of 150 over a 3 month period per Mahalla cluster.
- Previous research indicates that appropriately 33% of pregnant women will return to their home village following the delivery, thus leaving an expected number of eligible births of 200 over a 6 month period per Mahalla cluster.
- 39 mother-infant dyads per Mahalla cluster assuming 95% participation but 22% loss to follow-up based on earlier research,from the approximately 200 mother-infant dyads available in each cluster over a 6 month period.
- 90% power and 5% two-sided alpha
- Intra-cluster correlation coefficient (ICC) of 0.015 [based on analyses of the child anthropometric measurements from the 2004 Bangladesh DHS survey data for urban child populations.
- Expected difference in the prevalence of stunting between the treatment groups of 10% (35% in control to 25% in intervention group), which is similar to the change reported in an earlier education intervention for young child feeding in Peru.
The sample size required would be 1950 mother-infant pairs (975 in each treatment group) from 50 Mallahas clusters with 39 mother-infant dyads per community cluster recruited over 3 months.
Describe the availability of physical facilities at site of conduction of the study. For clinical and laboratory-based studies, indicate the provision of hospital and other types of adequate patient care and laboratory support services. Identify the laboratory facilities and major equipment that will be required for the study. For field studies, describe the field area including its size, population, and means of communications.
(a). Manpower (b). Administrative infra-structure (c). Expertise (d). Anthropometric equipment's
Intervention plan The trial intervention has been selected because its feasibility has been tested in urban populations in Dhaka, and it is likely to be sustainable in the future. The proposed individual peer counseling education will be of sufficient intensity to alter infant and young child feeding practices and to improve the growth of the young children and prevent malnutrition. After one year of preparations for the trial, the interventions will be delivered to the women starting in pregnancy and until their child is one year of age over the second and third years of the study.
a. Description of intervention The approach to promoting appropriate infant and young child feeding will be through a program of home-based peer counselling by trained, local women from the mothers' community. This approach will reach mothers who deliver at home and will also allow the messages to reach other key family members who may play a role in supporting breastfeeding and influence the foods choices for the infant. The main messages will be directed at encouraging early initiation of breastfeeding, promoting exclusive breastfeeding during the first 6 months of life, promoting appropriate timing of the introduction of complementary feeds, and ensuring an adequate frequency of feeds and diversity of foods used in their preparation.
i) Selection and training of peer counsellors Women with personal breastfeeding experience, at least 6 years of schooling, residing in the same area, and motivated to work will be selected to become peer counselors. The WHO/UNICEF Breastfeeding Counseling Course adopted to the local language and culture, which has already been validated in a previous study will be used for training of peer counselors. The training will be given for 40-h (4-h daily for 10 days). Counseling skills will be taught mainly by demonstrations and role play and will include: listening to mothers, learning about their difficulties, assessing the position and attachment of babies during breastfeeding, building mother's confidence, giving support and providing relevant information and practical help when required. During the training course antenatal and postpartum counseling will be practiced with pregnant women, mothers with newborns and infants aged 1-12 months in the field site. The counselors will also be taught how to use locally available foods for complementary feeding of infants and young children, and how best to demonstrate these food preparation skills to mothers.
It is anticipated that each peer counselor will be able to support up to approximately 10 mothers and thus to provide support to the approximately 1000 women receiving the intervention (see section 4.a. Sample Size and Power for details) 100 peer counselors (four in each community cluster) will need to be recruited and trained. The performance of the counselors will be monitored at least four times during the course of the study by the Senior Infant Feeding Counselors.
ii) Counselling schedules: There will be a schedule of at least 13 visits by the peer counsellors: two before delivery; four during the first month; five monthly visits from age 2 to 6 months; and three monthly visits at age 9 and 12 months. The counsellors will be free to make additional visits if the mother's circumstances require them. The counselling will take place at home to ensure key family members (e.g. mother-in-law and fathers) can also be included in the counselling sessions. The duration of each visit will be from 20 to 40 minutes.
Antenatal visits: The peer counsellors during the two antenatal contacts will prepare the mothers, and other members of the family who will support her at delivery, about the importance of holding the baby within a few minutes of delivery and how to initiate breastfeeding within one hour of delivery. They will discourage prelacteal feeds and other fluids and foods after lactation has been initiated. They will encourage the mothers to eat more of their usual foods to support enhanced lactation, and to appropriately rest during the third trimester. These meetings will also cover problems with breastfeeding that the mother might encounter and how best to deal with them.
Visits in the first month of life: The mothers will be contacted four times by the peer counsellors (within 48 hours of delivery, at 5-7 days, at 10-14 days and at 24-28 days). At these visits exclusive breastfeeding will be encouraged and the mother's specific needs addressed. Issues that could be covered include sore nipples, problems with attachment tot eh breast, the baby's position during feeds, family pressure to start other foods and mothers' doubts about the adequacy of their breastmilk. If any of these issues could not be resolved the mothers could be referred to the Senior Infant Feeding Counsellors.
Visits 2 to 6 months of life: The mothers will be contacted monthly by the peer counsellors. Specific problems will be addressed and continued support for exclusive breastfeeding will be provided especially how to deal with family pressures to introduce other foods and concerns about the adequacy of the growth of the infant. From 5 months of age specific messages that include, the importance of complementary feeding, demonstration and preparation of complementary foods will be introduced. Mothers will be given measuring cups and spoons and two types of complementary foods will be demonstrated. The two types of complementary feeds to be promoted are based on prior survey of foods given to young children in urban Dhaka. The first will be "rice-suzi" (powdered rice + soybean oil to make it energy dense), and the second will be "Khichri" (cooked rice + lentil + soybean oil). Mothers will also be discouraged from using bottles for feeding.
Visits from 6 to 12 months of life: The mothers will be contacted twice at 3 month intervals by the peer counsellors. The mothers will be encouraged to continue breastfeeding and support will be given for an adequate frequency of complementary feeds and an appropriate diversity foods. There will be further demonstrations of the preparation of complementary feeds as needed.
b. Management of interventions There will be two senior infant feeding counsellors who will train the peer counsellors under supervisor of CI-B. These senior counsellors will provide technical support to the peer counsellors and help them resolve problems they encounter during the implementation of the trial interventions by regular meetings with peer counsellors in the field. . There will be 10 field supervisors who will support the day-to-day logistics and administration of the field activities including support for the senior infant feeding counsellors when they are in the field and the per counsellors.
To facilitate the overall implementation process, an advisory committee consisting of a local health officers, local government officials, representatives of mothers' groups from the community, representatives of the Bangladesh Breastfeeding Foundation, other relevant NGOs and project staff will help guide the research team and will meet every 3 months as the project progresses.