Feasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot Study

Abstract

Background: Obesity is common in women of reproductive age and increases the risk during pregnancy. Exercising during this period reduces health complications. Home e-health programs are effective in overcoming exercise barriers as pregnant women use technology and the internet for health information. Methods: A single-blind randomized controlled feasibility study with pregnant women with obesity (body mass index [BMI] ≥30 kg/m2) was conducted in the University Hospital Center of São João between January and April 2023. Pregnant women were randomized to a control group with standard care and to an experimental group with 8-week remote exercise program using a Phoenix® biofeedback device. Feasibility outcome measures were recruitment rate (≥35%), loss to follow-up (≤15%), and program fidelity (≥1 session/week). Secondary outcomes were evaluated through Pregnancy Physical Activity Questionnaire, Oswestry Index on Disability, and weight assessments at baseline and at the end of the program. Results: Of the 63 eligible participants, 24 (38.1%) were successfully randomized and completed the baseline assessment. Of these, 3 (4.8%) from experimental group did not perform the initial onboarding. The control group had 8.3% of follow-up losses and for the experimental group there were no follow-up losses. Program fidelity (mean ≥1 session/week) was fulfilled by 66.7% of successfully randomized participants. Regarding secondary outcomes assessed between baseline and the 8th week, experimental group compared to control group had higher levels of physical activity for sports activities, a lower level of inactivity, and lower disability rates caused by low back pain. Conclusions: Based on the recruitment rate, losses to follow-up, and fidelity rate, the GROB (obesity in pregnancy) study was deemed feasible and worthy of consideration for a larger study. Moreover, the GROB study has the potential to improve maternal outcomes by reducing sedentarism and disability caused by low back pain. Clinical Trial Registration: The study has been registered on https://classic.clinicaltrials.gov/ (registration number: NCT05331586).