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

Caroline Borup Roland*, Signe De Place Knudsen, Saud Abdulaziz Alomairah, Anne Dsane Andersen, Jane Bendix, Tine D. Clausen, Stig Molsted, Andreas Kryger Jensen, Grete Teilmann, Astrid Pernille Jespersen, Jakob Eg Larsen, Gerrit Van Hall, Emil Andersen, Romain Barrès, Ole Hartvig Mortensen, Helle Terkildsen Maindal, Lise Tarnow, Ellen Christine Leth Løkkegaard, Bente Stallknecht

*Corresponding author for this work

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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.

Original languageEnglish
Article numbere043671
JournalBMJ Open
Volume11
Issue number3
Number of pages11
DOIs
Publication statusPublished - 19 Mar 2021

Bibliographical note

Funding Information:
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.

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Keywords

  • Clinical physiology
  • Obstetrics
  • Public health
  • Sports medicine

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