Work

Gestational Weight Gain Management in Underserved Mothers - A State-Wide Randomized Controlled Trial in Louisiana WIC

Year: 2025

Type: preprint

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: ABSTRACT Importance Underserved pregnant individuals experience the highest risk of aberrant pregnancy weight gain and adverse perinatal outcomes. The Women, Infants, and Children (WIC) federal program assists underserved pregnant individuals and is therefore positioned to offer equitable access to interventions to enhance gestational weight gain in accordance with clinical guidelines. Objective Test effectiveness of a pragmatic, fully remote lifestyle intervention co-developed with WIC participants on the incidence of gestational weight gain guideline attainment and perinatal outcomes. Design The SmartMoms in WIC trial was a single-blind randomized clinical trial conducted from July 2019 to May 2024. Setting Louisiana WIC Program pregnant participants across 31 participating WIC clinics. Participants 1300 individuals were recruited from Louisiana WIC; 756 were excluded via phone call and 544 were screened in person; 351 were enrolled. Randomization was stratified by geographical region and BMI class. Intervention A high intensity multicomponent e-health intervention (“Healthy Beginnings”) for gestational weight gain management or usual care between 10 to 16 weeks gestation and until delivery (∼24 weeks). Main Outcome(s) and Measure(s) The primary outcome was assessed at participants’ WIC clinic and included gestational weight gain guideline attainment with total observed weight gain, weight gain per week and deviation from guidelines as secondary outcomes. Perinatal outcomes from birth certificates were exploratory. Results The study sample (179 Intervention; 172 Usual Care) was diverse: 39% with obesity; 57% non-Hispanic Black. The incidence of guideline attainment was not different between groups. Study observed total (adjusted mean difference, –1.4 kg; 95% CI, –2.8 to –0.1), and rate of weight gain (adjusted mean difference –0.07 kg/wk; 95% CI, –0.13 to –0.01) and the deviation from guidelines was lower in the Intervention Group compared to Usual Care. There were 43 cases (16/172 Intervention, 27/171 Usual Care) of preterm birth and 30 NICU admissions (12/172 Intervention, 18/171 Usual Care) equating to an adjusted relative risk reduction of 36.9% and 28.6%, respectively. Conclusions and Relevance A fully remote lifestyle intervention concomitant with WIC clinical care lowered gestational weight gain and reduced the risk of preterm birth and NICU admission. Trial Registration ClinicalTrials.gov NCT04028843 ABSTRACT Background Underserved pregnant individuals experience the highest risk for weight gain outside clinical guidelines and adverse perinatal outcomes. The Women, Infants, and Children (WIC) federal program assists underserved pregnant individuals with supplemental nutrition. WIC is positioned to offer equitable access to interventions promoting recommended gestational weight gain, complementing clinical care. Methods In a state-wide randomized controlled trial, pregnant WIC participants were randomly assigned to a co-developed multicomponent e-health intervention for gestational weight gain management or usual care between 10 to 16 weeks gestation. The primary outcome was gestational weight gain guideline attainment. Study observed weight gain, weight gain per week and deviation from guidelines were secondary outcomes. Perinatal outcomes from birth certificates were exploratory. Results Pregnant participants (n=351) were enrolled (179 Intervention; 172 Usual Care) across 31 WIC clinics. The study sample was diverse: 39% with obesity; 57% non-Hispanic Black. The incidence of guideline attainment was not different between groups. Study observed weight gain (adjusted mean difference, –1.4 kg; 95% CI, –2.8 to –0.1), rate (adjusted mean difference, –0.07 kg/wk; 95% CI, –0.13 to –0.01) and the deviation from guidelines was lower in the Intervention Group compared to Usual Care. There were 43 cases (16/172 Intervention, 27/171 Usual Care) of preterm birth and 30 NICU admissions (12/172 Intervention, 18/171 Usual Care) equating to an adjusted relative risk reduction of 36.9% and 28.6%, respectively. Conclusion A fully remote lifestyle intervention concomitant with WIC clinical care lowered gestational weight gain and reduced the risk of preterm birth and NICU admission. Trial registration ClinicalTrials.gov NCT04028843 Key Points Question Can a pragmatic, fully remote lifestyle intervention improve gestational weight gain and perinatal outcomes in underserved pregnant WIC participants? Findings In this state-wide randomized controlled trial that included 351 pregnant WIC participants, the incidence of National Academy of Medicine guideline attainment for weight gain did not differ. Study observed gestational weight gain, preterm birth, and NICU admissions were lower in the Intervention Group. Meaning A fully remote lifestyle intervention concomitant with WIC clinical care attenuated gestational weight gain and improved perinatal outcomes.

Source: medRxiv

DOI: 10.1101/2025.01.29.25321347