Randomized Controlled Trial of a Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

In low- and middle-income countries (LMIC), growth impairment is common during infancy and has a devastating impact on health, increasing the risk of infectious disease, cognitive impairment, and overall morbidity and mortality. Low birth weight (LBW) infants are at especially high risk of these adverse outcomes and often struggle to grow. Under such conditions, maternal postpartum stress and anxiety levels are often greatly elevated, interfering with maternal well-being and further contributing to poor infant health. Recently, randomized controlled trials conducted in high-income countries reported that audiorecordings promoting relaxation during breastfeeding increase milk transfer from mother to infant and improve infant growth while reducing maternal stress and anxiety. However, no studies have yet tested this intervention in a low-income country, where the factors contributing to infant growth impairment and maternal stress may differ from those in high-income settings. To evaluate whether an audiorecording promoting relaxation during breastfeeding can improve infant growth and bolster maternal well-being in a low-income country, we propose the Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW) study. RING-MW will begin by using qualitative and quantitative methods to develop and adapt an audiorecording promoting relaxation during breastfeeding so that it is culturally relevant and feasible for use by the local postpartum population. RING-MW will then assess the efficacy of this adapted audiorecording in a pilot randomized controlled trial which will enroll 100 recently postpartum mothers experiencing moderate-to-high stress and their breastfeeding, LBW newborns in Kampala, Uganda. Enrolled mother-infant dyads will be randomly assigned either to an audiorecording promoting relaxation during breastfeeding (intervention group) or to usual care (control group). Baseline data will be collected at enrollment, and mothers and infants will be followed at 1, 2, 4, and 12 weeks after birth and assessed for infant growth, feeding, and adverse events; milk intake and immunoglobulin levels; and maternal stress, anxiety and depression. The effect of treatment assignment on these outcomes will be reported using both intention-to-treat and per protocol approaches, and metrics will be collected to inform future implementation work should the intervention demonstrate efficacy. The feasibility of the proposal is supported by the investigators’ previous successful collaborations at the enrolling hospital in Kampala, Uganda. Audiorecordings promoting relaxation during breastfeeding are an inexpensive intervention and are potentially highly scalable in LMIC. If our intervention demonstrates efficacy in the low-income country setting of Uganda, we hope it may be possible to conduct a future larger clinical trial to examine effectiveness, informed by the implementation metrics gathered in this pilot work. Given the scalability of audiorecordings, if an audiorecording promoting relaxation during breastfeeding were to be shown effective at improving infant growth or maternal well-being, the potential for global health benefit could be substantial. Project Number: 3R21HD117269-01A1S1 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Valerie Flaherman (+1 co-PI) | Institution: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, SAN FRANCISCO, CA | Award Amount: $150,514 | Activity Code: R21 | Study Section: Lifestyle Change and Behavioral Health Study Section[LCBH] View on NIH RePORTER: https://reporter.nih.gov/project-details/3R21HD11726901A1S1