NCT03679130: FitMum-RCT

FitMum: Fitness for Good Health of Mother and Child

Completed NA Last updated 30 September 2022

What this trial tests

NA trial testing Structured supervised exercise training in Pregnancy Related in 220 participants. Completed in 8 June 2022.

Timeline

19 September 2018

Primary endpoint
5 March 2021

8 June 2022

Quick facts

Lead sponsor	Nordsjaellands Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	220
Start date	19 September 2018
Primary completion	5 March 2021
Estimated completion	8 June 2022
Sites	1 location across Denmark

Drugs / interventions tested

• Structured supervised exercise training
• Motivational counseling supported by health technology

Conditions studied

• Pregnancy Related — all drugs for Pregnancy Related →
• Physical Activity — all drugs for Physical Activity →

Sponsor

Nordsjaellands Hospital

Who can join

18 and older, female only, with Pregnancy Related or Physical Activity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women's Physical Activity Level: FitMum - Randomized Controlled Trial.
   Knudsen SP, Alomairah SA, Roland CB, Jessen AD, et al · · 2022 · cited 23× · PMID 35857356 · DOI 10.2196/37699
2. Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol.
   Roland CB, Knudsen SP, Alomairah SA, Andersen AD, et al · · 2021 · cited 15× · PMID 33741668 · DOI 10.1136/bmjopen-2020-043671
3. The effect of exercise training and motivational counselling on physical activity behaviour and psychosocial factors in pregnant women: secondary analyses of the FitMum randomised controlled trial investigating prenatal physical activity.
   Knudsen SP, Roland CB, Alomairah SA, Jessen AD, et al · · 2024 · cited 8× · PMID 38178045 · DOI 10.1186/s12889-023-17525-3
4. Effects of prenatal exercise on gestational weight gain, obstetric and neonatal outcomes: FitMum randomized controlled trial.
   Roland CB, Knudsen SD, Alomairah SA, Jessen AD, et al · · 2023 · cited 8× · PMID 36991380 · DOI 10.1186/s12884-023-05507-7
5. Effects of Two Physical Activity Interventions on Sleep and Sedentary Time in Pregnant Women.
   Alomairah SA, Knudsen SP, Roland CB, Molsted S, et al · · 2023 · cited 7× · PMID 37047973 · DOI 10.3390/ijerph20075359
6. 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.
   Jensen IKB, Budtz-Jørgensen E, Lindh C, Roland CB, et al · · 2025 · cited 4× · PMID 40176054 · DOI 10.1186/s12940-025-01170-x
7. Mother's heart rate: a valid way to measure physical activity during pregnancy? Data from the FitMum RCT.
   Jensen IKB, Jessen AD, Gundersen SV, Roland CB, et al · · 2025 · cited 1× · PMID 40421177 · DOI 10.1136/bmjsem-2025-002458
8. Effects of prenatal exercise interventions on maternal body composition: A secondary analysis of the FitMum randomized controlled trial.
   Roland CB, Seyedhosseini P, Knudsen SP, Jessen AD, et al · · 2024 · cited 1× · PMID 39088510 · DOI 10.1371/journal.pone.0308214