Effect of nutrition counseling on undernutrition among children aged 6–23 months in West Gojjam Zone, Northwest Ethiopia: a cluster-randomized trial

Abstract Background Child undernutrition continues to pose a substantial public health burden in low-resource settings, including Ethiopia. The complementary feeding period (6–23 months) represents a particularly vulnerable stage, during which inappropriate feeding practices may increase the risk of growth faltering. Therefore, this study aimed to evaluate the effect of nutrition counseling on undernutrition among children aged 6–23 months in West Gojjam Zone, Northwest Ethiopia. Methods A two-arm, parallel, cluster-randomized trial was conducted from June 2023 to December 2024 in rural districts of West Gojjam Zone. Thirty kebeles were randomized as clusters and allocated equally to intervention and control arms. At baseline, 802 mothers with infants aged 6–8 months were enrolled (401 per arm) and followed for nine months; anthropometric data were available for 391 intervention and 385 control participants. The intervention comprised structured theory-driven nutrition counseling delivered through home visits by trained Women’s Development Army leaders using an intervention guide, while controls received routine nutrition education. Blinding of participants and counselors was not feasible due to the nature of the intervention. Data were collected using interviewer-administered questionnaires, and anthropometry was measured at baseline and endline. Generalized estimating equations were used to assess the intervention effect, while accounting for clustering and repeated measurements. Results After adjustment, the nutrition counseling intervention was associated with 36% lower odds of stunting compared with the control group (AOR = 0.64; 95% CI, 0.43–0.95; p = 0.026). Because four co-primary outcomes were evaluated without adjustment for multiple comparisons, this nominally statistically significant finding should not be regarded as confirmatory evidence. No significant intervention effects were observed for wasting, underweight, or overall undernutrition (defined as the presence of stunting, wasting, or underweight) over time. Female sex was protective against stunting, while children aged 20–23 months had higher odds of stunting but lower odds of wasting and underweight. Conclusion The nutrition counseling intervention showed a possible beneficial effect on stunting, whereas no clear intervention effects were observed for wasting, underweight, or overall undernutrition. Because four co-primary outcomes were evaluated without adjustment for multiplicity, and the trial included 30 clusters with moderate intervention fidelity, the stunting finding should be considered suggestive rather than confirmatory. Adequately powered cluster-randomized trials are warranted to confirm this finding. These findings support further investigation of theory-driven nutrition counseling integrated within maternal and child health services in similar rural settings. Trial registration ClinicalTrials.gov, NCT05871346 (first publicly posted on 23 May 2023). Cluster randomization was conducted after public posting, participant enrollment began on 9 June 2023, and the intervention was initiated immediately after enrollment. Thus, the trial was publicly registered before cluster randomization, participant enrollment, and intervention initiation.