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

doi:10.1136/bmjopen-2020-043671

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

BMJ Open. 2021 Mar 19;11(3):e043671. doi: 10.1136/bmjopen-2020-043671.

Authors

Caroline Borup Roland^{1

2}, Signe de Place Knudsen^{3

2}, Saud Abdulaziz Alomairah^{3

4}, Anne Dsane Andersen², Jane Bendix², Tine D Clausen^{2

5}, Stig Molsted⁶, Andreas Kryger Jensen^{6

7}, Grete Teilmann⁸, Astrid Pernille Jespersen⁹, Jakob Eg Larsen¹⁰, Gerrit van Hall^{3

11}, Emil Andersen¹², Romain Barrès¹², Ole Hartvig Mortensen³, Helle Terkildsen Maindal^{13

14}, Lise Tarnow¹⁵, Ellen Christine Leth Løkkegaard^{2

5}, Bente Stallknecht³

Affiliations

¹ Department of Biomedical Sciences, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, Denmark cba@sund.ku.dk.
² Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.
³ Department of Biomedical Sciences, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, Denmark.
⁴ Department of Public Health, Saudi Electronic University, Riyadh, Saudi Arabia.
⁵ Department of Clinical Medicine, University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, Denmark.
⁶ Department of Clinical Research, Nordsjaellands Hospital, Hillerod, Denmark.
⁷ Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
⁸ Department of Paediatrics, Nordsjaellands Hospital, Hillerod, Denmark.
⁹ The Saxo Institute, University of Copenhagen, Centre for Health Research in the Humanities, Copenhagen, Denmark.
¹⁰ Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark.
¹¹ Clinical Metabolomics Core Facility, Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.
¹² Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.
¹³ Department of Public Health, Aarhus Universitet, Aarhus, Denmark.
¹⁴ Steno Diabetes Center Copenhagen, Gentofte, Denmark.
¹⁵ Steno Diabetes Center Copenhagen, Holbaek, Denmark.

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.

Keywords: clinical physiology; obstetrics; public health; sports medicine.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Exercise
Exercise Therapy
Female
Humans
Life Style
Mothers*
Motivational Interviewing*
Pregnancy
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT03679130