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 (approximately 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.

The authors have declared no competing interest.

ClinicalTrials.gov NCT04028843

This research was supported by funding from the National Institute of Nursing Research (5R01NR017644), the Louisiana/Pennington Nutrition and Obesity Research Center (NORC) of the National Institutes of Diabetes, Digestive and Kidney Diseases (P30DK072476) and the Louisiana Clinical and Translational Sciences Center (U54 GM104940).

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval for this was was given by the institutional review boards of Pennington Biomedical Research Center and the Louisiana Department of Health.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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A deidentified dataset will be made publicly available in the Pennington/Louisiana NORCBiorepository at http://doi.org/10.17616/R31NJN8P

http://doi.org/10.17616/R31NJN8P