FitMum: Fitness for Good Health of Mother and Child

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2022-06-08

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.

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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.

Conditions

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Pregnancy Related Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Structured exercise training (EXE)

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.

Group Type EXPERIMENTAL

Structured supervised exercise training

Intervention Type 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.

Motivational counseling (MOT)

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.

Group Type EXPERIMENTAL

Motivational counseling supported by health technology

Intervention Type 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.

Control group (CON)

Control group receiving standard treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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EXE MOT

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes