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

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 informatio...

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Main Authors: Diana Bernardo, Carolina Bobadilla-Agouborde, Clarinda Festas, Carlos Carvalho, Pedro Pugliesi Abdalla, Carmen Amezcua-Prieto, Zeltia Naia-Entonado, Cristina Carvalho Mesquita, Jorge Mota, Paula Clara Santos
Format: Article
Language:English
Published: IMR Press 2024-03-01
Series:Clinical and Experimental Obstetrics & Gynecology
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Online Access:https://www.imrpress.com/journal/CEOG/51/3/10.31083/j.ceog5103070
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author Diana Bernardo
Carolina Bobadilla-Agouborde
Clarinda Festas
Carlos Carvalho
Pedro Pugliesi Abdalla
Carmen Amezcua-Prieto
Zeltia Naia-Entonado
Cristina Carvalho Mesquita
Jorge Mota
Paula Clara Santos
author_facet Diana Bernardo
Carolina Bobadilla-Agouborde
Clarinda Festas
Carlos Carvalho
Pedro Pugliesi Abdalla
Carmen Amezcua-Prieto
Zeltia Naia-Entonado
Cristina Carvalho Mesquita
Jorge Mota
Paula Clara Santos
author_sort Diana Bernardo
collection DOAJ
description 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).
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spelling doaj-art-4aa82626d1994fbcac9455285e60ba712025-08-20T01:56:31ZengIMR PressClinical and Experimental Obstetrics & Gynecology0390-66632024-03-015137010.31083/j.ceog5103070S0390-6663(24)02308-XFeasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot StudyDiana Bernardo0Carolina Bobadilla-Agouborde1Clarinda Festas2Carlos Carvalho3Pedro Pugliesi Abdalla4Carmen Amezcua-Prieto5Zeltia Naia-Entonado6Cristina Carvalho Mesquita7Jorge Mota8Paula Clara Santos9Department of Physical Medicine and Rehabilitation, University Hospital Center of São João, 4200-319 Porto, PortugalResearch Center in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport University of Porto (FADEUP), 4200-450 Porto, PortugalNow with Department of Physiotherapy, Health School Fernando Pessoa, 4249-004 Porto, PortugalDepartment of Physyiothepy, Clinical Physiotherapy Practice, 4100-465 Porto, PortugalStudy and Research Group in Anthropometry, Training, and Sport (GEPETE), University of São Paulo, School of Physical Education and Sport of Ribeirão Preto (EEFERP-USP), 14040-907 Ribeirão Preto (São Paulo), BrazilDepartment of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18010 Granada, SpainDepartment of Physiotherapy, Medicine and Biomedical Sciences, Faculty of Physiotherapy, University of A Coruña, 15071 Coruña, SpainCentro de Investigação em Reabilitação, Escola Superior de Saúde, Instituto Politécnico do Porto, 4249-015 Porto, PortugalResearch Center in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport University of Porto (FADEUP), 4200-450 Porto, PortugalResearch Center in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport University of Porto (FADEUP), 4200-450 Porto, PortugalBackground: 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).https://www.imrpress.com/journal/CEOG/51/3/10.31083/j.ceog5103070pregnancyexercisephysical activityobesitye-healthremote
spellingShingle Diana Bernardo
Carolina Bobadilla-Agouborde
Clarinda Festas
Carlos Carvalho
Pedro Pugliesi Abdalla
Carmen Amezcua-Prieto
Zeltia Naia-Entonado
Cristina Carvalho Mesquita
Jorge Mota
Paula Clara Santos
Feasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot Study
Clinical and Experimental Obstetrics & Gynecology
pregnancy
exercise
physical activity
obesity
e-health
remote
title Feasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot Study
title_full Feasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot Study
title_fullStr Feasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot Study
title_full_unstemmed Feasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot Study
title_short Feasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot Study
title_sort feasibility clinical efficacy and maternal outcomes of a remote exercise program in pregnant women with obesity the grob randomized control pilot study
topic pregnancy
exercise
physical activity
obesity
e-health
remote
url https://www.imrpress.com/journal/CEOG/51/3/10.31083/j.ceog5103070
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