A Randomized Controlled Pilot Trial of a Behavioral Physical Activity Intervention for Pregnancy Hyperglycemia.

Introduction: This randomized controlled pilot trial evaluated a behavioral physical activity (PA) intervention for individuals with pregnancy hyperglycemia and explored the feasibility of a fully powered efficacy trial. Materials and Methods: The pilot trial sought to enroll and randomize participants to a 5-week-long behavioral PA intervention that promoted walking or stepping (i.e., in place or around a small area) versus a general wellness intervention (that provided no information on PA, diet, or metabolism), both delivered remotely via weekly, 10-20-min-long counseling sessions with a lifestyle coach. Participants (N = 20) completed surveys, including the Pregnancy Physical Activity Questionnaire, and wore ActiGraph CentrePoint watches for 7 days at baseline and at follow-up. Nineteen participants (95%) completed follow-up study visits. A subset (85%) had neonatal anthropometric measurements due to pandemic-related restrictions. Results: One hundred and twenty individuals were screened, with 54% (n = 65) meeting eligibility criteria and receiving physician approval to contact; 26% of the eligible enrolled, were randomized, and completed a baseline visit. Ninety percent of those randomized to the PA intervention (n = 9) completed it, rating the PA intervention as excellent (56%) or very good (44%). The PA intervention mitigated late pregnancy declines in self-reported walking and running activity (follow-up minus baseline: 0.22 MET h/week [95% CI -0.41, 0.84] in the PA intervention vs. -0.70 [-1.31, -0.10] in controls), and there was the suggestion of improvements in neonatal birthweight for gestational age Z-score and subscapular skinfold. Conclusion: Findings suggest that the behavioral PA intervention promoting unsupervised, moderate-intensity walking or stepping, which could easily be delivered in conjunction with clinical medical nutrition therapy, was acceptable. The intervention may mitigate late pregnancy declines in moderate-intensity PA and remains to be investigated in a full-scale randomized controlled efficacy trial. Trial Registration: ClinicalTrials.gov identifier: NCT06125704.