Development, validation and evaluation of pilot randomised controlled trial of a nutrition and physical activity module (MomEENS) to improve psychosocial well-being for postpartum mothers with preterm infants

Postpartum depression (PPD) is a common mental health condition among mothers of preterm infants, often driven by prolonged hospitalisation, especially in the Neonatal Intensive Care Unit (NICU), related stress, and disrupted postpartum recovery. Evidence indicates that adequate nutrition and regular physical activity are effective non-pharmacological strategies for reducing depressive symptoms and improving psychosocial well-being during the postpartum period. However, in Malaysia, postpartum mothers, particularly those with preterm infants, lack of structured, evidence-based guidance on nutrition and physical activity, while traditional confinement practices (TCP) may further influence maternal health behaviours and mental well-being. This study employs a quantitative design aimed at developing, validating, and evaluating a nutrition and physical activity intervention module (MomEENS: Mommies can Eat and Exercise with No Stress) to improve psychosocial well-being among postpartum mothers with preterm infants in the NICU setting. Guided by the ADDIE (Analysis, Design, Development, Implementation, and Evaluation) model and Social Cognitive Theory, the study was conducted in three phases. Phase 1 (Analysis) involved a cross-sectional study to identify risk factors associated with postpartum depression (PPD) among mothers with preterm infants (n=351) in a selected NICU in several general hospitals in Selangor. Additionally, a scoping review was conducted to examine existing nutrition and physical activity interventions designed to enhance postpartum mental health. Phase II (Design and Development) focused on developing and validating a new module- MomEENS (Mommies can Eat and Exercise with No Stress). This phase involved content validation by expert panels (n = 16) and face validation (n = 61) among postpartum mothers. Further, Phase III (Implementation and Evaluation) was a pilot randomised controlled trial study (RCT) among postpartum mothers with preterm infants (n=26), comparing intervention (n=13) and control groups (n=13) to assess changes in postpartum depression, perceived stress, sleep quality, and psychosocial well-being of postpartum mothers. Data were analysed using SPSS Statistics version 29. Multiple logistic regression identified risk factors for PPD, while repeated measures ANOVA assessed the module’s effects on psychosocial well-being measures. Findings from Phase I found a PPD prevalence of 21.1%, with extended NICU stays (p<0.001), Malay ethnicity (p=0.042), high NICU-related stress (p<0.001), not practising or incompletely adhering to TCP (p<0.001), and low physical activity (p=0.035) were associated with a higher risk of PPD. The scoping review supported the notion that nutrition and physical activity interventions can improve postpartum mental health; however, such interventions are still lacking in Malaysia. Phase II produced and validated the MomEENS module, achieving an expert-panel content-validity index of 0.98 (≥0.90) and face validity ratings above 90% (criterion ≥75%). Phase III, results showed significant time-related improvements in postpartum depression (p<0.001, Ƞp2=0.251), with greater improvements in the intervention group. A trend was observed for reduced maternal stress (p=0.070, Ƞp2=0.105). Psychosocial well-being, as measured by the Positive Affect Balance Scale, improved more in the intervention group than in the control group (p = 0.037, Ƞp² = 0.169), although no significant time-by-group interactions emerged. In conclusion, the MomEENS module shows promising preliminary effectiveness in improving PPD symptoms and psychosocial well-being among mothers of preterm infants, warranting further evaluation in larger-scale randomised controlled trials.