Clinical trial NCT03679130: FitMum: Fitness for Good Health of Mother and Child
Official title: FitMum: Fitness for Good Health of Mother and Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Physical Activity
Keywords: Pregnancy
Physical activity
Healthy
Epigenetics
Process evaluation
Doubly labeled water
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: University of Aarhus
name: University of Graz
name: Deakin University
name: University of Copenhagen
First posted: 2018-09-20
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
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 ]'
timeFrame: Continuously 24/7 from inclusion (at latest GA week 15+0) to GA week 28+0-6
Secondary outcomes:
measure: Gestational weight gain
timeFrame: Baseline weight, weight at inclusion, weight at GA week 28+0-6, weight at GA 34+0-6 and weight at delivery.
measure: Complementary measures of physical activity level - by PPAQ-DK
timeFrame: At inclusion, GA week 28+0-6 and 34+0-6
measure: Complementary measures of physical activity level - by doubly labeled water
timeFrame: At GA week 28+0-6
measure: Complementary measures of physical activity level - by activity tracker
timeFrame: Continuously 24/7 from inclusion to delivery
measure: Complementary measures of physical activity level - by activity tracker
timeFrame: Continuously 24/7 from delivery and one year ahead
measure: Clinical outcomes of mother and child
timeFrame: Delivery
measure: Maternal body composition during pregnancy
timeFrame: At GA week 28+0-6
measure: Maternal body composition after delivery
timeFrame: One week after delivery
measure: Maternal health-related quality of life and function
timeFrame: At inclusion, GA week 28+0-6, 34+0-6, and one year after delivery
measure: Maternal sick leave and pelvic and low back pain
timeFrame: At inclusion, GA week 28+0-6, and 34+0-6
measure: Maternal sleep - by activity tracker
timeFrame: Continuously 24/7 from inclusion (at latest GA week 15+0) to 1 year after delivery
measure: Maternal sleep - by PSQI
timeFrame: At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery
measure: Metabolic markers in mother and child
timeFrame: At inclusion, GA week 28+0-6, 34+0-6, and delivery
measure: DNA methylation
timeFrame: At GA week 34+0-6 and delivery.
measure: Placental function
timeFrame: At delivery
measure: Personal understandings of physical activity in everyday life - by qualitative interviews
timeFrame: From inclusion (at latest GA week 15+0) to delivery
measure: Personal understandings of physical activity in everyday life - by observations
timeFrame: From inclusion (at latest GA week 15+0) to delivery
measure: Personal understandings of physical activity in everyday life - by auto-documentation
timeFrame: From inclusion (at latest GA week 15+0) to delivery
measure: A process evaluation of FitMum RCT interventions
timeFrame: From inclusion (at latest GA week 15+0) to delivery
measure: Physical activity behavior changes among pregnant women
timeFrame: At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery
measure: Motivation for physical activity among pregnant women
timeFrame: At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery
measure: Offspring growth in the first year of life
timeFrame: At 5 weeks, 5 months and 12 moths after delivery
measure: Physical psycho-motor development in the offspring
timeFrame: One year after due date
measure: Physical activity level in the offspring for 7 days, determined by a wrist band accelerometer Actigraph GT3X+
timeFrame: One year after due date until one year and 7 days after due date
measure: Mental well-being in mothers and fathers post partum
timeFrame: 6 weeks after delivery
measure: Validation of activity tracker, Garmin Vivosport, for measuring sleep
timeFrame: For one night, between GA week 28+0 until delivery
measure: Breastmilk composition
timeFrame: 7-14 days after delivery
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
Study officials:
affiliation: Department of Biomedical Sciences at University of Copenhagen
name: Bente M Stallknecht, PhD, DMSc
role: STUDY_DIRECTOR
affiliation: Department of Gynecology and Obstetrics at Nordsjaellands Hospital
name: Ellen CL Løkkegaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.