FitMum: Fitness for Good Health of Mother and Child

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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FitMum: Fitness for Good Health of Mother and Child

Conditions
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Pregnancy Related, Physical Activity

Intervention / Treatment
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* Behavioral: Structured supervised exercise training
* Behavioral: Motivational counseling supported by health technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained before any trial related procedures are performed Pregnant woman aged 18 years or older Gestational age of max. 15+0 weeks Ultrasonic confirmed intrauterine pregnancy BMI of 18.5-40 kg/m2 calculated from pre-pregnancy weight or first measured weight in pregnancy Exclusion Criteria: Severe chronic disease Structured exercise at moderate to vigorous intensity more than 1 hour per week during pregnancy Previous preterm delivery (before GA week 37) Obstetric or medical complications Multiple pregnancies Non-Danish speaking Alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: FitMum RCT is designed as an open-labeled single-site three-arm randomized controlled trial, including 220 pregnant women no later than gestational age week 15+0 days. Included women will be randomized in a 2:2:1 ratio to receive a structured supervised exercise training (EXE) intervention, receive a motivational counseling intervention supported by health technology (MOT), or a control group receiving standard treatment (CON), respectively. The participants in the EXE and MOT groups continue in the physical activity intervention as long as their pregnancy allows and ideally until delivery, in total approximately six months. Collection of data for assessment of the primary outcome will take place from randomization (one week after inclusion) to GA week 28+0-6 and will be measured by a commercial activity tracker. Secondary outcomes will be examined at Nordsjaellands Hospital six times during the study period. Time frames and methods for assessment of outcomes are specified below.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Structured exercise training (EXE)<br>Structured supervised exercise training (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. | Behavioral: Structured supervised exercise training<br>* 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.<br>* Other names: EXE;|
| Experimental: Motivational counseling (MOT)<br>Motivational counseling supported by health technology (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. | Behavioral: Motivational counseling supported by health technology<br>* 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.<br>* Other names: MOT;|
| No Intervention: Control group (CON)<br>Control group receiving standard treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Continuously 24/7 from inclusion (at latest GA week 15+0) to GA week 28+0-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Weight gain during pregnancy | 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. | 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. | At GA week 28+0-6 | 
| 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. | 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. | 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. | Delivery | 
| Maternal body composition during pregnancy | Maternal body composition will be assessed by doubly labeled water during pregnancy. | At GA week 28+0-6 | 
| Maternal body composition after delivery | Maternal body composition will be assessed by DXA scanning after delivery. | 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). | 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. | 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. | 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). | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 7-14 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Physical activity, Healthy, Epigenetics, Process evaluation, Doubly labeled water