FitMum: Fitness for Good Health of Mother and Child

NCT03679130 | Completed

• 1 other identifier: H-18011067
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pregnancy Related; Physical Activity

Keywords

Pregnancy; Physical activity; Healthy; Epigenetics; Process evaluation; Doubly labeled water

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Gestational weight gain

  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

  At inclusion, GA week 28+0-6 and 34+0-6

• Complementary measures of physical activity level - by doubly labeled water

  At GA week 28+0-6

• Complementary measures of physical activity level - by activity tracker

  Continuously 24/7 from inclusion to delivery

• Complementary measures of physical activity level - by activity tracker

  Continuously 24/7 from delivery and one year ahead

Study Arms (3)

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.

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.

Behavioral: Motivational counseling supported by health technology

Control group (CON)

NO INTERVENTION

Control group receiving standard treatment.

Interventions

Structured supervised exercise training BEHAVIORAL

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.

Also known as: EXE

Structured exercise training (EXE)

Motivational counseling supported by health technology BEHAVIORAL

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.

Also known as: MOT

Motivational counseling (MOT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: As only women can be pregnant, only women are eligible in participating in the interventional part of the study. However, we encourage the biological father of the child to consent on providing a paternal blood sample for epigenetic analysis.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Technical University of Denmark: collaborator
• University of Aarhus: collaborator
• University of Graz: collaborator
• Deakin University: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (7)

• Jessen 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.

  PMID: 41044147 DERIVED

• Jensen 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.

  PMID: 40176054 DERIVED

• Roland 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.

  PMID: 39088510 DERIVED

• Alomairah 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.

  PMID: 37047973 DERIVED

• Roland 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.

  PMID: 36991380 DERIVED

• Knudsen 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.

  PMID: 35857356 DERIVED

• Roland 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.

  PMID: 33741668 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Bente M Stallknecht, PhD, DMSc

  Department of Biomedical Sciences at University of Copenhagen

  STUDY DIRECTOR

• Ellen CL Løkkegaard, PhD

  Department of Gynecology and Obstetrics at Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, PhD

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 20, 2018
• Study Start: September 19, 2018
• Primary Completion: March 5, 2021
• Study Completion: June 8, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)