A physically active lifestyle during pregnancy has potential to improve maternal and child health. However, less than four out of ten Danish pregnant women succeed to achieve 30 minutes of daily physical activity at moderate intensity as recommended by the Danish Health Authorities. This project investigates how to implement physical activity in pregnant women´s everyday life by testing the efficacy of two very different exercise programs on physical activity level during pregnancy.
Low levels of physical activity during pregnancy constitute a significant public health issue as increasing evidence suggests that the mother's lifestyle during pregnancy may influence the future health of her child. A physically active lifestyle during pregnancy has potential to improve metabolic health of mother and child and thus may play an important role in relation to counteracting the obesity epidemic and the increasing incidence of metabolic diseases that escalates globally. However, less than four out of ten Danish pregnant women succeed to achieve 30 minutes of daily physical activity at moderate intensity as recommended by the Danish Health Authorities. The key gap in evidence and practice towards tackling the significant public health issue of being physically inactive during pregnancy is lack of evidence of how physical activity can be implemented. Only very few and scattered regional or municipal physical activity initiatives are currently targeting Danish pregnant women, and these are mainly targeted overweight women. Implementing and validating means to empower the pregnant women to be physically active have the potential to establish the norm of being physically active during pregnancy and might halt the negative spiral effect of physical inactivity, obesity and metabolic diseases that escalates globally. The aim of FitMum RCT is to evaluate the effects of structured supervised exercise training and motivational counseling supported by health technology on physical activity level during pregnancy. The two exercise programs are designed to meet the motivators and overcome the specific barriers for physical activity among pregnant women. The programs will be tested in a three-armed randomized controlled trial including 220 healthy, physically inactive, pregnant women. FitMum is carried out in collaboration between University of Copenhagen, Nordsjaellands Hospital, Technical University of Denmark, Aarhus University and international researchers. During the COVID-19 pandemic supplies of interventions and test visits are periodically changed. During lockdown periods, all interventions and test visits (except delivery) are converted into online versions. In EXE, the water exercise sessions are replaced with online land exercises. All land exercise sessions consist of 30 min of aerobic exercise where the participants exercise on their own followed by 30 min of supervised online group resistance training. All individual and group MOT sessions are held online. As much data as possible is collected during the pandemic, but in some periods, biological samples and DXA scans have been cancelled and participants were weighed at home.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
220
EXE contains three weekly one-hour exercise sessions at moderate intensity, more specifically one water exercise session and two land exercise sessions. The training will be supervised, held in teams, and both water and land exercise sessions will consist of a combination of aerobic and resistance training.
MOT contains four individual and three group counseling sessions taking place from randomization until GA week 33+6 and aim to motivate the participants to increase their physical activity level at moderate intensity. During individual sessions, feedback on physical activity performance will be provided based on activity data acquired from the activity tracker and further, MOT-participants will receive weekly SMS-reminders about physical activity.
Nordsjællands Hospital
Hillerød, Denmark
Min/week of moderate-to-vigorous-intensity physical activity from randomization to GA week 28+0-6 determined by a Garmin Vivosport activity tracker [ Time Frame: Continuously 24/7 from inclusion (at latest GA week 15+0) to GA week 28+0-6 ]'
Physical activity level from randomization to GA week 28+0-6 determined by a wrist-worn activity tracker, Garmin Vivosport, with built-in heart rate monitor and accelerometer. The activity tracker is to be worn continuously by the women from inclusion until delivery. After inclusion baseline physical activity level will be measured for one week, followed by randomization to one of the three study groups and continuous monitoring of physical activity level by the activity tracker. Preferably, the activity tracker is also worn continuously from delivery and one year ahead. The activity tracker determines the frequency, duration and intensity of activity periods on a minute-to-minute basis and data from the activity tracker is wirelessly synced to its associated smartphone application, Garmin Connect, and research platform, Fitabase.
Time frame: Continuously 24/7 from inclusion (at latest GA week 15+0) to GA week 28+0-6
Gestational weight gain
Weight gain during pregnancy
Time frame: Baseline weight, weight at inclusion, weight at GA week 28+0-6, weight at GA 34+0-6 and weight at delivery.
Complementary measures of physical activity level - by PPAQ-DK
A Danish version of the validated 'Pregnancy Physical Activity Questionnaire' (PPAQ-DK) will be used to subjectively measure physical activity level during pregnancy.
Time frame: At inclusion, GA week 28+0-6 and 34+0-6
Complementary measures of physical activity level - by doubly labeled water
The doubly labeled water technique will be used to measure free-living energy expenditure at GA week 28+0-6.
Time frame: At GA week 28+0-6
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Complementary measures of physical activity level - by activity tracker
The activity tracker will also be used to measure physical activity level of the mother during the entire pregnancy period, meaning after GA week 28+0-6 until delivery as well.
Time frame: Continuously 24/7 from inclusion to delivery
Complementary measures of physical activity level - by activity tracker
The activity tracker will also be used to measure physical activity level of the mother one year after delivery.
Time frame: Continuously 24/7 from delivery and one year ahead
Clinical outcomes of mother and child
Clinical pregnancy, delivery and neonatal outcomes will be collected from medical records. E.g. incidence of Gestational Diabetes Mellitus, gestational age at delivery, mode of delivery, induction of labor, epidural, 5-minute Apgar score, pH of umbilical cord and birth weight.
Time frame: Delivery
Maternal body composition during pregnancy
Maternal body composition will be assessed by doubly labeled water during pregnancy.
Time frame: At GA week 28+0-6
Maternal body composition after delivery
Maternal body composition will be assessed by DXA scanning after delivery.
Time frame: One week after delivery
Maternal health-related quality of life and function
Health-related quality of life and function will be determined by a Danish version of the questionnaire "Medical Outcomes Study Short Form 36" (SF-36).
Time frame: At inclusion, GA week 28+0-6, 34+0-6, and one year after delivery
Maternal sick leave and pelvic and low back pain
Sick leave and pelvic and low back pain will be assessed by a questionnaire verbally administered at interviews at visits.
Time frame: At inclusion, GA week 28+0-6, and 34+0-6
Maternal sleep - by activity tracker
Sleep quantity and quality will be assessed continuously by the activity tracker.
Time frame: Continuously 24/7 from inclusion (at latest GA week 15+0) to 1 year after delivery
Maternal sleep - by PSQI
Sleep quantity and quality will be assessed by a Danish version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI).
Time frame: At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery
Metabolic markers in mother and child
Plasma metabolites and hormones (e.g. triglyceride, HDL, LDL, total cholesterol and HbA1C) will be assessed by analysing maternal blood and umbilical cord blood.
Time frame: At inclusion, GA week 28+0-6, 34+0-6, and delivery
DNA methylation
Epigenetic profiles will be assessed by analysing DNA methylation in maternal blood, paternal blood and umbilical cord blood.
Time frame: At GA week 34+0-6 and delivery.
Placental function
Placental function will be assessed via analyses of placental samples, maternal blood and umbilical cord blood.
Time frame: At delivery
Personal understandings of physical activity in everyday life - by qualitative interviews
Investigations of personal understandings of physical activity in everyday life of pregnant women and social, structural and cultural practices and factors influencing successful implementation of exercise during pregnancy will be based on semi-structured qualitative interviews
Time frame: From inclusion (at latest GA week 15+0) to delivery
Personal understandings of physical activity in everyday life - by observations
Investigations of personal understandings of physical activity in everyday life of pregnant women and social, structural and cultural practices and factors influencing successful implementation of exercise during pregnancy. Data will be collected by observations
Time frame: From inclusion (at latest GA week 15+0) to delivery
Personal understandings of physical activity in everyday life - by auto-documentation
Investigations of personal understandings of physical activity in everyday life of pregnant women and social, structural and cultural practices and factors influencing successful implementation of exercise during pregnancy. Data will be collected by auto-documentation.
Time frame: From inclusion (at latest GA week 15+0) to delivery
A process evaluation of FitMum RCT interventions
Mixed methods will be used to do a qualitative and quantitative process evaluation. Data for the process evaluation are based on semi-structured qualitative interviews and administratively collected process data (e.g. frequency of training and counseling sessions, visits and measurements), electronic case report form files, and activity logs.
Time frame: From inclusion (at latest GA week 15+0) to delivery
Physical activity behavior changes among pregnant women
Self-efficacy for physical activity will be measured by a Danish version of the American questionnaire "Pregnancy Exercise Self-efficacy Scale" (P-ESES-DK).
Time frame: At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery
Motivation for physical activity among pregnant women
Motivation for physical activity will be measured by a Danish version of the British questionnaire "Behavioral Regulation Exercise Questionnaire" (BREQ-2).
Time frame: At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery
Offspring growth in the first year of life
Growth in the offspring will be assessed by questionnaires, using data from visits to the participants' general practitioners.
Time frame: At 5 weeks, 5 months and 12 moths after delivery
Physical psycho-motor development in the offspring
Physical psycho-motor development in the offspring will be assessed using a Danish version of the questionnaires Ages and Stages 3 (ASQ-3) for 12- and 14 month old babies.
Time frame: One year after due date
Physical activity level in the offspring for 7 days, determined by a wrist band accelerometer Actigraph GT3X+
Physical activity level one year after due date, determined by a wrist-worn accelerometer, Actigraph GT3X+. The activity tracker is to be worn continuously by offspring for 7 days. Data is stored in the device and transferred to the researchers' computer.
Time frame: One year after due date until one year and 7 days after due date
Mental well-being in mothers and fathers post partum
Mental well-being in mothers and fathers post partum will be assessed using a Danish validated screening-tool for parental post-partum depression, primarily based on the Edinburgh Postnatal Depression Scale and selected questions from The Masculine Depression Scale.
Time frame: 6 weeks after delivery
Validation of activity tracker, Garmin Vivosport, for measuring sleep
validation of activity trackers for measuring sleep will be conducted using polysomnography (PSG) in a sub-group of forty women already participating in FitMum RCT. The women will wear the PGS for one night.
Time frame: For one night, between GA week 28+0 until delivery
Breastmilk composition
Breastmilk for metabolomics and lipidomics analyses is obtained from one single feed 7-14 days after delivery.
Time frame: 7-14 days after delivery