Impact of a Prenatal Nutrition Package with Balanced Energy Supplementation on Gestational Weight Gain in Amhara, Ethiopia

BACKGROUND: Suboptimal gestational weight gain (GWG) is associated with adverse pregnancy outcomes; however, evidence on the impact of nutritional interventions on GWG in low-income settings remains limited OBJECTIVE: To examine the effectiveness of an enhanced nutrition package (ENP), including a balanced energy protein (BEP) supplement, on GWG compared to routine care. METHODS: trimester weights. Secondary dose-response analysis within the ENP arm examined associations between BEP consumption duration and GWG outcomes. RESULTS: A total of 2392 women were enrolled and randomized (n=1210 ENP; n=1189 routine care), with 2170 followed up until birth. In the ENP arm, 37% were eligible for BEP supplementation. ITT analysis showed no differences between arms in GWG rate (diff= -0.006 kg/week; 95%CI: -0.042, 0.030) or observed GWG (diff= 0.009 kg; 95%CI: -0.687, 0.706). Among BEP-eligible women, GWG outcomes also did not differ between arms (ΔGWG rate= 0.006 kg/week; 95%CI: -0.027, 0.030); observed ΔGWG= 0.201 kg (95%CI: -0.443, 0.845). In dose-response analysis within the ENP arm, women consuming BEP for 61-90 and >90 days had a higher GWG rate (61-90 days: 0.46 kg/wk, 95% CI: 0.003 to 0.090); >90 days: 0.059 kg/week; 95%CI:0.018 to 0.099) and observed GWG (61-90 days: 0.895 kg, 95% CI 0.004 to 1.786 kg; >90 days: 1.206 kg, 95%CI: 0.331, 2.081) compared to those consuming BEP for <30 days. CONCLUSIONS: The ENP package, including BEP, did not improve GWG compared to routine care in this pragmatic study in the Ethiopian health system. Longer duration of prenatal BEP adherence (at least 60 days) may benefit GWG and GWG rates among undernourished women. CLINICAL TRIAL REGISTRY: ISRCTN15116516.