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Feasibility, clinical efficacy, and maternal outcomes of a remote exercise program in pregnant women with obesity: the GROB randomized control pilot study
Bernardo D, Agouborde CB, Festas C, Carvalho C, Abdalla PP, Prieto CA, Entonado ZN, Mesquita CC, Mota J, Santos PC
Clinical and Experimental Obstetrics & Gynecology 2024 Mar;51(3):70
clinical trial
This trial has not yet been rated.

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 Sao Joao 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 (mean1 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).

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