Breastfeeding, Exclusive Clinical Trial
Official title:
Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding in Southwest Ethiopia: a Cluster Randomized Controlled Trial.
The purpose of this study is to develop and test Breastfeeding Education and Support
Intervention for improving timely initiation and Exclusive Breastfeeding rate.
Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the
simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does
not meet the international recommendation for exclusive breastfeeding (EBF) for the first six
months of life. Community-based educational and support interventions provided prenatally and
postnatally are effective in increasing BF rates. However, there is paucity of such
information in Ethiopia.
Sample size was calculated using Sample Size Calculator (SSC) a Windows based software
package (93) with the following assumptions: to detect an increase in exclusive breastfeeding
for 6 month from 52% to 72% (44), with 95% Confidence Intervals and 80% power, assuming an
intra-cluster correlation coefficient of 0•1 from Ugandan study (94) for a cluster size of
ten, it is calculated that we will need thirty six clusters. Adding 20% of the sample size
for loss to follow-up, the final sample size is 432 pregnant women (216 in intervention, and
216 in control).
Standard operating procedure will be prepared and used for data collection. Data will be
entered into Epi-data version 3.1 and analyzed using STATA version 12.0. Frequency
distributions will be run to identify outliers. In relation to the trial hypotheses,
intervention group will be compared to the routine education using intention to treat
analysis. For the outcomes, proportions of women who initiated BF timely and who exclusively
breastfed their babies at 72 hours and at 6 month will be compared using odds ratios derived
using logistic regression between intervention and control groups. In all analyses,
adjustment will be made for clustering at the zone level since randomization was done at
cluster level rather than individual level. Generalized linear models will be used to
calculate prevalence ratios (PR) for the categorical anthropometric outcomes. In the
longitudinal analysis, the correlated nature of the data from the repeated measurements will
be taken into account by adjusting for repeated measurements in the same individual as well
as the above-mentioned design effect resulting from the cluster randomization. A linear mixed
effects regression model will be used in the longitudinal analysis of z-scores with cluster
as a random effect and the repeated measurements in each child accounted for through a first
order autocorrelation structure. Least Squares Means (LSM) are reported at 3, 6 months,
corresponding to the scheduled data collection visits.
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