Effects of guided counseling during pregnancy on birth weight of newborns in West Gojjam Zone, Ethiopia: a cluster-randomized controlled trial

Background The high proportion of birth weight in Ethiopia is hypothesized to be due to inadequate maternal diet which is associated with poor nutrition education during pregnancy. There was no study that evaluated the effect of nutrition education on birth weight in the study area. This study aimed to assess the effects (overall, direct and indirect effects) of guided counseling on the birth weight of neonates. Methods A two-arm parallel cluster randomized controlled community trial was conducted from May 1, 2018, to April 30, 2019, in West Gojjam Zone, Northwest Ethiopia. At the baseline, 346 pregnant women in the 11 intervention clusters and 348 pregnant women in the 11 control clusters were recruited. However, birth weight was measured from 258 and 272 newborns in the intervention and control groups, respectively.In the intervention group, counseling was given monthly for four consecutive months in the participant's homes. Besides, leaflets with key counseling messages were distributed to each woman in the intervention arm. Pregnant women who attended routine nutrition education given by the health system were recruited as control. Dietary practice, nutritional status, and birth weight were the primary, secondary and tertiary outcomes of this intervention. Data were collected using a structured data collection tool. Birth weight was measured within 48h after birth. Independent sample t-test, linear mixed-effects model, and path analysis were fitted to assess effects of the intervention. Results The intra-cluster correlation coefficient was 0.095. The average birth weight of newborns in the intervention group was 0.257kg higher compared with their counterparts in the control arm (beta= 0.257, P<0.001). The direct effect of this intervention on birth weight was 0.17 (beta= 0.17, P<0.001) whereas the indirect effect of this intervention was 0.08 (beta= 0.08, P<0.001). Conclusion Counseling using the health belief model and the theory of planned behavior has a positive effect on improving birth weight. The findings suggest the need for enhancing nutrition education of pregnant women through the application of theories to improve birth weight.Trial registrationClinical Trials.gov NCT03627156, Retrospectively registered Jun, 13, 2018.