FitMum: Fitness for Good Health of Mother and Child (FitMum-RCT)

Nordsjaellands Hospital

Status: Completed

Conditions: Physical Activity; Pregnancy Related

Treatments: Behavioral: Motivational counseling supported by health technology; Behavioral: Structured supervised exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT03679130

H-18011067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

Structured exercise training (EXE)

Experimental group

Description:

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.

Treatment:

Behavioral: Structured supervised exercise training

Motivational counseling (MOT)

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational counseling supported by health technology

Control group (CON)

No Intervention group

Description:

Control group receiving standard treatment.