Pregnancy RelatedFitMum-RCTNCT03679130
FitMum: Fitness for Good Health of Mother and Child
A study testing Structured supervised exercise training and Motivational counseling supported by health technology in people with Pregnancy Related and Physical Activity, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Physical Activity
- What is being tested?
- Structured supervised exercise training and Motivational counseling supported by health technology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Sep 2018to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Pregnancy Related, Physical Activity
- Being tested
- Structured supervised exercise training, Motivational counseling supported by health technology
- Keywords
- Pregnancy, Physical activity, Healthy, Epigenetics, Process evaluation, Doubly labeled water
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured supervised exercise trainingBehavioural
Also called EXE
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.
Motivational counseling supported by health technologyBehavioural
Also called MOT
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured exercise training (EXE) | Experimental | 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. Receives: Behavioral: Structured supervised exercise training |
| Motivational counseling (MOT) | Experimental | 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. Receives: Behavioral: Motivational counseling supported by health technology |
| Control group (CON) | No intervention | Control group receiving standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Continuously 24/7 from inclusion (at latest GA week 15+0) to GA week 28+0-6
Secondary outcomes (27)
Gestational weight gain
Weight gain during pregnancy
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Delivery
Maternal body composition during pregnancy
Maternal body composition will be assessed by doubly labeled water during pregnancy.
Measured: At GA week 28+0-6
Maternal body composition after delivery
Maternal body composition will be assessed by DXA scanning after delivery.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7-14 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start19 Sep 2018
- Primary completion5 Mar 2021
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, University of Aarhus, University of Graz, Deakin University, University of Copenhagen
- Responsible party
- Principal investigator, Ellen Christine Leth Loekkegaard, Nordsjaellands Hospital
- Investigators
- Bente M Stallknecht, PhD, DMSc, Study director, Department of Biomedical Sciences at University of CopenhagenEllen CL Løkkegaard, PhD, Principal investigator, Department of Gynecology and Obstetrics at Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679130
- Sponsor's protocol ID
- H-18011067
- Acronym
- FitMum-RCT
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2018
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Roland CB, Hernandez-Saavedra D, Khan A, Trost K, Moritz T, Braendstrup N, Knudsen SD, Jessen AD, Molsted S, Clausen TD, Alomairah SA, Lokkegaard E, Stallknecht B, Stanford KI, Bendix JM. Prenatal exercise interventions result in subtle changes in the human breast milk metabolome and lipidome 7-14 days postpartum: exploratory analyses of the FitMum randomized controlled trial. Int Breastfeed J. 2026 Jun 2. doi: 10.1186/s13006-026-00857-2. Online ahead of print.
PubMed 42231447Jessen AD, Alomairah SA, Jensen IKB, de Place Knudsen S, Roland CB, Bendix JM, Molsted S, Lokkegaard E, Stallknecht B. Mapping postpartum physical activity, sedentary time, and sleep: assessing the impact of prenatal physical activity interventions in the FitMum randomized controlled trial. Sci Rep. 2025 Oct 3;15(1):34606. doi: 10.1038/s41598-025-18186-5.
PubMed 41044147Jensen IKB, Budtz-Jorgensen E, Lindh C, Roland CB, de Place Knudsen S, Bendix JM, Molsted S, Clausen TD, Stallknecht B, Mortensen OH, Lokkegaard E, Knudsen LE. Serum concentrations of per- and poly-fluoroalkyl substances (PFAS) in Danish pregnant women-temporal trends during pregnancy, correlations with partners, associations with physical activity, and blood lipid concentrations. Environ Health. 2025 Apr 2;24(1):16. doi: 10.1186/s12940-025-01170-x.
PubMed 40176054Roland CB, Seyedhosseini P, Knudsen SP, Jessen AD, Jensen IKB, Bendix JM, van Hall G, Molsted S, Alomairah SA, Lokkegaard E, Stallknecht B, Clausen TD. Effects of prenatal exercise interventions on maternal body composition: A secondary analysis of the FitMum randomized controlled trial. PLoS One. 2024 Aug 1;19(8):e0308214. doi: 10.1371/journal.pone.0308214. eCollection 2024.
PubMed 39088510Alomairah SA, Knudsen SP, Roland CB, Molsted S, Clausen TD, Bendix JM, Lokkegaard E, Jensen AK, Larsen JE, Jennum P, Stallknecht B. Effects of Two Physical Activity Interventions on Sleep and Sedentary Time in Pregnant Women. Int J Environ Res Public Health. 2023 Mar 31;20(7):5359. doi: 10.3390/ijerph20075359.
PubMed 37047973Roland CB, Knudsen SD, Alomairah SA, Jessen AD, Jensen IKB, Braendstrup N, Molsted S, Jensen AK, Stallknecht B, Bendix JM, Clausen TD, Lokkegaard E. Effects of prenatal exercise on gestational weight gain, obstetric and neonatal outcomes: FitMum randomized controlled trial. BMC Pregnancy Childbirth. 2023 Mar 29;23(1):214. doi: 10.1186/s12884-023-05507-7.
PubMed 36991380Knudsen SP, Alomairah SA, Roland CB, Jessen AD, Hergel IM, Clausen TD, Larsen JE, van Hall G, Jensen AK, Molsted S, Bendix JM, Lokkegaard E, Stallknecht B. Effects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women's Physical Activity Level: FitMum - Randomized Controlled Trial. J Med Internet Res. 2022 Jul 20;24(7):e37699. doi: 10.2196/37699.
PubMed 35857356Roland CB, Knudsen SP, Alomairah SA, Andersen AD, Bendix J, Clausen TD, Molsted S, Jensen AK, Teilmann G, Jespersen AP, Larsen JE, Hall GV, Andersen E, Barres R, Mortensen OH, Maindal HT, Tarnow L, Lokkegaard ECL, Stallknecht B. 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.
PubMed 33741668
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FitMum: Fitness for Good Health of Mother and Child
- ClinicalTrials.gov ID
- NCT03679130
- Acronym / sponsor ID
- FitMum-RCT / H-18011067
- Conditions
- Pregnancy Related, Physical Activity
- Keywords
- Pregnancy, Physical activity, Healthy, Epigenetics, Process evaluation, Doubly labeled water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Technical University of Denmark, University of Aarhus, University of Graz, Deakin University, University of Copenhagen
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Structured exercise training (EXE) | Experimental | Behavioral: Structured supervised exercise trainingStructured 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. |
| Motivational counseling (MOT) | Experimental | Behavioral: Motivational counseling supported by health technologyMotivational 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. |
| Control group (CON) | No intervention | –Control group receiving standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured supervised exercise trainingAlso: EXEEXE 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. | Behavioural | Structured exercise training (EXE) |
| Motivational counseling supported by health technologyAlso: MOTMOT 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. | Behavioural | Motivational counseling (MOT) |
Primary outcome
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 ]'
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.
27 secondary outcomes
Gestational weight gain
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
Time frame: At inclusion, GA week 28+0-6 and 34+0-6
Complementary measures of physical activity level - by doubly labeled water
Time frame: At GA week 28+0-6
Complementary measures of physical activity level - by activity tracker
Time frame: Continuously 24/7 from inclusion to delivery
Complementary measures of physical activity level - by activity tracker
Time frame: Continuously 24/7 from delivery and one year ahead
Clinical outcomes of mother and child
Time frame: Delivery
Maternal body composition during pregnancy
Time frame: At GA week 28+0-6
Maternal body composition after delivery
Time frame: One week after delivery
Maternal health-related quality of life and function
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
Time frame: At inclusion, GA week 28+0-6, and 34+0-6
Maternal sleep - by activity tracker
Time frame: Continuously 24/7 from inclusion (at latest GA week 15+0) to 1 year after delivery
Maternal sleep - by 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
Time frame: At inclusion, GA week 28+0-6, 34+0-6, and delivery
DNA methylation
Time frame: At GA week 34+0-6 and delivery.
Placental function
Time frame: At delivery
Personal understandings of physical activity in everyday life - by qualitative interviews
Time frame: From inclusion (at latest GA week 15+0) to delivery
Personal understandings of physical activity in everyday life - 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
Time frame: From inclusion (at latest GA week 15+0) to delivery
A process evaluation of FitMum RCT interventions
Time frame: From inclusion (at latest GA week 15+0) to delivery
Physical activity behavior changes among pregnant women
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
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
Time frame: At 5 weeks, 5 months and 12 moths after delivery
Physical psycho-motor development in the offspring
Time frame: One year after due date
Physical activity level in the offspring for 7 days, determined by a wrist band accelerometer Actigraph GT3X+
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
Time frame: 6 weeks after delivery
Validation of activity tracker, Garmin Vivosport, for measuring sleep
Time frame: For one night, between GA week 28+0 until delivery
Breastmilk composition
Time frame: 7-14 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Derived from this study: PubMed 42231447Roland CB, Hernandez-Saavedra D, Khan A, Trost K, Moritz T, Braendstrup N, Knudsen SD, Jessen AD, Molsted S, Clausen TD, Alomairah SA, Lokkegaard E, Stallknecht B, Stanford KI, Bendix JM. Prenatal exercise interventions result in subtle changes in the human breast milk metabolome and lipidome 7-14 days postpartum: exploratory analyses of the FitMum randomized controlled trial. Int Breastfeed J. 2026 Jun 2. doi: 10.1186/s13006-026-00857-2. Online ahead of print.
- Derived from this study: PubMed 41044147Jessen AD, Alomairah SA, Jensen IKB, de Place Knudsen S, Roland CB, Bendix JM, Molsted S, Lokkegaard E, Stallknecht B. Mapping postpartum physical activity, sedentary time, and sleep: assessing the impact of prenatal physical activity interventions in the FitMum randomized controlled trial. Sci Rep. 2025 Oct 3;15(1):34606. doi: 10.1038/s41598-025-18186-5.
- Derived from this study: PubMed 40176054Jensen IKB, Budtz-Jorgensen E, Lindh C, Roland CB, de Place Knudsen S, Bendix JM, Molsted S, Clausen TD, Stallknecht B, Mortensen OH, Lokkegaard E, Knudsen LE. Serum concentrations of per- and poly-fluoroalkyl substances (PFAS) in Danish pregnant women-temporal trends during pregnancy, correlations with partners, associations with physical activity, and blood lipid concentrations. Environ Health. 2025 Apr 2;24(1):16. doi: 10.1186/s12940-025-01170-x.
- Derived from this study: PubMed 39088510Roland CB, Seyedhosseini P, Knudsen SP, Jessen AD, Jensen IKB, Bendix JM, van Hall G, Molsted S, Alomairah SA, Lokkegaard E, Stallknecht B, Clausen TD. Effects of prenatal exercise interventions on maternal body composition: A secondary analysis of the FitMum randomized controlled trial. PLoS One. 2024 Aug 1;19(8):e0308214. doi: 10.1371/journal.pone.0308214. eCollection 2024.
- Derived from this study: PubMed 37047973Alomairah SA, Knudsen SP, Roland CB, Molsted S, Clausen TD, Bendix JM, Lokkegaard E, Jensen AK, Larsen JE, Jennum P, Stallknecht B. Effects of Two Physical Activity Interventions on Sleep and Sedentary Time in Pregnant Women. Int J Environ Res Public Health. 2023 Mar 31;20(7):5359. doi: 10.3390/ijerph20075359.
- Derived from this study: PubMed 36991380Roland CB, Knudsen SD, Alomairah SA, Jessen AD, Jensen IKB, Braendstrup N, Molsted S, Jensen AK, Stallknecht B, Bendix JM, Clausen TD, Lokkegaard E. Effects of prenatal exercise on gestational weight gain, obstetric and neonatal outcomes: FitMum randomized controlled trial. BMC Pregnancy Childbirth. 2023 Mar 29;23(1):214. doi: 10.1186/s12884-023-05507-7.
- Derived from this study: PubMed 35857356Knudsen SP, Alomairah SA, Roland CB, Jessen AD, Hergel IM, Clausen TD, Larsen JE, van Hall G, Jensen AK, Molsted S, Bendix JM, Lokkegaard E, Stallknecht B. Effects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women's Physical Activity Level: FitMum - Randomized Controlled Trial. J Med Internet Res. 2022 Jul 20;24(7):e37699. doi: 10.2196/37699.
- Derived from this study: PubMed 33741668Roland CB, Knudsen SP, Alomairah SA, Andersen AD, Bendix J, Clausen TD, Molsted S, Jensen AK, Teilmann G, Jespersen AP, Larsen JE, Hall GV, Andersen E, Barres R, Mortensen OH, Maindal HT, Tarnow L, Lokkegaard ECL, Stallknecht B. 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.
- Individual participant dataSharing planned: Yes. Undecided: It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente M Stallknecht, PhD, DMSc study director
Department of Biomedical Sciences at University of Copenhagen
Ellen CL Løkkegaard, PhD principal investigator
Department of Gynecology and Obstetrics at Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured supervised exercise training and Motivational counseling supported by health technology in people with Pregnancy Related and Physical Activity, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 ]' (time frame: Continuously 24/7 from inclusion (at latest GA week 15+0) to GA week 28+0-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679130, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.