TY - JOUR

T1 - Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring

T2 - FitMum study protocol

AU - Roland, Caroline Borup

AU - Knudsen, Signe de Place

AU - Alomairah, Saud Abdulaziz

AU - Andersen, Anne Dsane

AU - Bendix, Jane

AU - Clausen, Tine D

AU - Molsted, Stig

AU - Jensen, Andreas Kryger

AU - Teilmann, Grete

AU - Jespersen, Astrid Pernille

AU - Larsen, Jakob Eg

AU - Hall, Gerrit van

AU - Andersen, Emil

AU - Barrès, Romain

AU - Mortensen, Ole Hartvig

AU - Maindal, Helle Terkildsen

AU - Tarnow, Lise

AU - Løkkegaard, Ellen Christine Leth

AU - Stallknecht, Bente

N1 - © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021/3/19

Y1 - 2021/3/19

N2 - INTRODUCTION: A physically active lifestyle during pregnancy improves maternal and offspring health but can be difficult to follow. In Denmark, less than 40% of pregnant women meet physical activity (PA) recommendations. The FitMum study aims to explore strategies to increase PA during pregnancy among women with low PA and assess the health effects of PA. This paper presents the FitMum protocol, which evaluates the effects of structured supervised exercise training or motivational counselling supported by health technology during pregnancy on PA level and health of mother and offspring.METHODS AND ANALYSIS: A single-site three-arm randomised controlled trial that aims to recruit 220 healthy, pregnant women with gestational age (GA) no later than week 15 and whose PA level does not exceed one hour/week. Participants are randomised to one of three groups: structured supervised exercise training consisting of three weekly exercise sessions, motivational counselling supported by health technology or a control group receiving standard care. The interventions take place from randomisation until delivery. The primary outcome is min/week of moderate-to-vigorous intensity PA (MVPA) as determined by a commercial activity tracker, collected from randomisation until GA of 28 weeks and 0-6 days, and the secondary outcome is gestational weight gain (GWG). Additional outcomes are complementary measures of PA; clinical and psychological health parameters in participant, partner and offspring; analyses of blood, placenta and breastmilk samples; process evaluation of interventions; and personal understandings of PA.ETHICS AND DISSEMINATION: The study is approved by the Danish National Committee on Health Research Ethics (# H-18011067) and the Danish Data Protection Agency (# P-2019-512). Findings will be disseminated via peer-reviewed publications, at conferences, and to health professionals via science theatre performances.TRIAL REGISTRATION NUMBER: NCT03679130.PROTOCOL VERSION: This paper was written per the study protocol version 8 dated 28 August 2019.

AB - INTRODUCTION: A physically active lifestyle during pregnancy improves maternal and offspring health but can be difficult to follow. In Denmark, less than 40% of pregnant women meet physical activity (PA) recommendations. The FitMum study aims to explore strategies to increase PA during pregnancy among women with low PA and assess the health effects of PA. This paper presents the FitMum protocol, which evaluates the effects of structured supervised exercise training or motivational counselling supported by health technology during pregnancy on PA level and health of mother and offspring.METHODS AND ANALYSIS: A single-site three-arm randomised controlled trial that aims to recruit 220 healthy, pregnant women with gestational age (GA) no later than week 15 and whose PA level does not exceed one hour/week. Participants are randomised to one of three groups: structured supervised exercise training consisting of three weekly exercise sessions, motivational counselling supported by health technology or a control group receiving standard care. The interventions take place from randomisation until delivery. The primary outcome is min/week of moderate-to-vigorous intensity PA (MVPA) as determined by a commercial activity tracker, collected from randomisation until GA of 28 weeks and 0-6 days, and the secondary outcome is gestational weight gain (GWG). Additional outcomes are complementary measures of PA; clinical and psychological health parameters in participant, partner and offspring; analyses of blood, placenta and breastmilk samples; process evaluation of interventions; and personal understandings of PA.ETHICS AND DISSEMINATION: The study is approved by the Danish National Committee on Health Research Ethics (# H-18011067) and the Danish Data Protection Agency (# P-2019-512). Findings will be disseminated via peer-reviewed publications, at conferences, and to health professionals via science theatre performances.TRIAL REGISTRATION NUMBER: NCT03679130.PROTOCOL VERSION: This paper was written per the study protocol version 8 dated 28 August 2019.

U2 - 10.1136/bmjopen-2020-043671

DO - 10.1136/bmjopen-2020-043671

M3 - Journal article

C2 - 33741668

VL - 11

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 3

M1 - e043671

ER -