Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol

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 amon...

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Main Authors: Astrid Pernille Jespersen, Andreas Kryger Jensen, Ellen Christine Leth Løkkegaard, Helle Terkildsen Maindal, Caroline Borup Roland, Signe de Place Knudsen, Saud Abdulaziz Alomairah, Anne Dsane Andersen, Jane Bendix, Tine D Clausen, Stig Molsted, Grete Teilmann, Jakob Eg Larsen, Gerrit van Hall, Emil Andersen, Romain Barrès, Ole Hartvig Mortensen, Lise Tarnow, Bente Stallknecht
Format: Article
Language:English
Published: BMJ Publishing Group 2021-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/3/e043671.full
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author Astrid Pernille Jespersen
Andreas Kryger Jensen
Ellen Christine Leth Løkkegaard
Helle Terkildsen Maindal
Caroline Borup Roland
Signe de Place Knudsen
Saud Abdulaziz Alomairah
Anne Dsane Andersen
Jane Bendix
Tine D Clausen
Stig Molsted
Grete Teilmann
Jakob Eg Larsen
Gerrit van Hall
Emil Andersen
Romain Barrès
Ole Hartvig Mortensen
Lise Tarnow
Bente Stallknecht
author_facet Astrid Pernille Jespersen
Andreas Kryger Jensen
Ellen Christine Leth Løkkegaard
Helle Terkildsen Maindal
Caroline Borup Roland
Signe de Place Knudsen
Saud Abdulaziz Alomairah
Anne Dsane Andersen
Jane Bendix
Tine D Clausen
Stig Molsted
Grete Teilmann
Jakob Eg Larsen
Gerrit van Hall
Emil Andersen
Romain Barrès
Ole Hartvig Mortensen
Lise Tarnow
Bente Stallknecht
author_sort Astrid Pernille Jespersen
collection DOAJ
description 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.
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spelling doaj-art-39132b566e004488b5dcf201a2ae1c292024-11-17T17:20:08ZengBMJ Publishing GroupBMJ Open2044-60552021-03-0111310.1136/bmjopen-2020-043671Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocolAstrid Pernille Jespersen0Andreas Kryger Jensen1Ellen Christine Leth Løkkegaard2Helle Terkildsen Maindal3Caroline Borup Roland4Signe de Place Knudsen5Saud Abdulaziz Alomairah6Anne Dsane Andersen7Jane Bendix8Tine D Clausen9Stig Molsted10Grete Teilmann11Jakob Eg Larsen12Gerrit van Hall13Emil Andersen14Romain Barrès15Ole Hartvig Mortensen16Lise Tarnow17Bente Stallknecht18The Saxo Institute, University of Copenhagen, Centre for Health Research in the Humanities, Copenhagen, DenmarkDepartment of Clinical Research, Nordsjaellands Hospital, Hillerod, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, DenmarkAarhus University, Aarhus, UKDepartment of Biomedical Sciences, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, DenmarkDepartment of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hillerod, DenmarkDepartment of Biomedical Sciences, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, DenmarkDepartment of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hillerod, DenmarkDepartment of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark8 Center for Pregnant Women with Diabetes, Department of Obstetrics, Copenhagen University Hospital Rigshospitalet, Copenhagen, DenmarkDepartment of Clinical Research, Nordsjaellands Hospital, Hillerod, DenmarkDepartment of Paediatrics, Nordsjaellands Hospital, Hillerod, DenmarkDepartment of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, DenmarkDepartment of Biomedical Sciences, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, DenmarkNovo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, DenmarkNovo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, DenmarkDepartment of Biomedical Sciences, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, DenmarkSteno Diabetes Center Copenhagen, Holbaek, DenmarkDepartment of Biomedical Sciences, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, DenmarkIntroduction 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.https://bmjopen.bmj.com/content/11/3/e043671.full
spellingShingle Astrid Pernille Jespersen
Andreas Kryger Jensen
Ellen Christine Leth Løkkegaard
Helle Terkildsen Maindal
Caroline Borup Roland
Signe de Place Knudsen
Saud Abdulaziz Alomairah
Anne Dsane Andersen
Jane Bendix
Tine D Clausen
Stig Molsted
Grete Teilmann
Jakob Eg Larsen
Gerrit van Hall
Emil Andersen
Romain Barrès
Ole Hartvig Mortensen
Lise Tarnow
Bente Stallknecht
Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol
BMJ Open
title Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol
title_full Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol
title_fullStr Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol
title_full_unstemmed Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol
title_short Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol
title_sort structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring fitmum study protocol
url https://bmjopen.bmj.com/content/11/3/e043671.full
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