You are here

  • Home
  • Archive
  • Volume 11, Issue 3
  • Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol

Article Text

Article menu
XML
Sports and exercise medicine
Protocol
Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol
  1. Caroline Borup Roland1,2,
  2. Signe de Place Knudsen1,2,
  3. Saud Abdulaziz Alomairah1,3,
  4. Anne Dsane Andersen2,
  5. Jane Bendix2,
  6. Tine D Clausen2,4,
  7. Stig Molsted5,
  8. Andreas Kryger Jensen5,6,
  9. Grete Teilmann7,
  10. Astrid Pernille Jespersen8,
  11. Jakob Eg Larsen9,
  12. Gerrit van Hall1,10,
  13. Emil Andersen11,
  14. Romain Barrès11,
  15. Ole Hartvig Mortensen1,
  16. Helle Terkildsen Maindal12,13,
  17. Lise Tarnow14,
  18. Ellen Christine Leth Løkkegaard2,4,
  19. Bente Stallknecht1
  1. 1Department of Biomedical Sciences, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, Denmark
  2. 2Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark
  3. 3Department of Public Health, Saudi Electronic University, Riyadh, Saudi Arabia
  4. 4Department of Clinical Medicine, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, Denmark
  5. 5Department of Clinical Research, Nordsjaellands Hospital, Hillerod, Denmark
  6. 6Department of Public Health, University of Copenhagen, Copenhagen, Denmark
  7. 7Department of Paediatrics, Nordsjaellands Hospital, Hillerod, Denmark
  8. 8The Saxo Institute, University of Copenhagen, Centre for Health Research in the Humanities, Copenhagen, Denmark
  9. 9Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark
  10. 10Clinical Metabolomics Core Facility, Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark
  11. 11Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark
  12. 12Department of Public Health, Aarhus Universitet, Aarhus, Denmark
  13. 13Steno Diabetes Center Copenhagen, Gentofte, Denmark
  14. 14Steno Diabetes Center Copenhagen, Holbaek, Denmark
  1. Correspondence to Mrs Caroline Borup Roland; cba{at}sund.ku.dk

Abstract

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.

  • obstetrics
  • sports medicine
  • public health
  • clinical physiology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2020-043671

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Twitter @jakobeglarsen

    • Contributors BS initiated the FitMum study together with LT and is the principal investigator of FitMum RCT. ECLL is the clinical trial manager. A steering group consisting of BS, ECLL, TDC, JEL and HTM oversees trial status and progression. CBR, SdPK and BS led the protocol development with contribution from SAA, ADA, JB, TDC, SM, AKJ, GT, APJ, JEL, GvH, EA, RB, OHM, HTM, LT and ECLL. CBR, SdPK, SAA, ADA, JB, TDC, SM, ECLL and BS constitute the clinical core group that guides the practical performance of FitMum RCT. CBR, SdPK and ADA conduct intervention activities together with research assistants and master’s students. CBR, SdPK, SAA and ADA will perform most of the data analysis along with AKJ. Analyses of the primary outcome will be performed by AKJ. All authors read, contributed to and approved the final version of the manuscript.

    • Funding The FitMum study has been financially supported by the Independent Research Fund Denmark (8020-00353B and 0218-00014B), TrygFonden (128509), Copenhagen Center for Health Technology (061017), Beckett-Fonden (17-2-0883), Aase and Ejnar Danielsens Fond (10-002052) and Familien Hede Nielsens Fond (2017-1142).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.