FitMum: Fitness for Good Health of Mother and Child
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- 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 ]'
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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 ]'
时间窗: 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.
次要结局
- 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 delivery and one year ahead)
- Clinical outcomes of mother and child(Delivery)
- Maternal body composition during pregnancy(At GA week 28+0-6)
- Maternal body composition after delivery(One week after delivery)
- DNA methylation(At GA week 34+0-6 and delivery.)
- Offspring growth in the first year of life(At 5 weeks, 5 months and 12 moths after delivery)
- Maternal health-related quality of life and function(At inclusion, GA week 28+0-6, 34+0-6, and one year after delivery)
- Maternal sick leave and pelvic and low back pain(At inclusion, GA week 28+0-6, and 34+0-6)
- Physical psycho-motor development in the offspring(One year after due date)
- Mental well-being in mothers and fathers post partum(6 weeks after delivery)
- Validation of activity tracker, Garmin Vivosport, for measuring sleep(For one night, between GA week 28+0 until delivery)
- Breastmilk composition(7-14 days after delivery)
- Maternal sleep - by activity tracker(Continuously 24/7 from inclusion (at latest GA week 15+0) to 1 year after delivery)
- Maternal sleep - by PSQI(At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery)
- Metabolic markers in mother and child(At inclusion, GA week 28+0-6, 34+0-6, and delivery)
- Personal understandings of physical activity in everyday life - by qualitative interviews(From inclusion (at latest GA week 15+0) to delivery)
- Physical activity level in the offspring for 7 days, determined by a wrist band accelerometer Actigraph GT3X+(One year after due date until one year and 7 days after due date)
- Placental function(At delivery)
- Personal understandings of physical activity in everyday life - by auto-documentation(From inclusion (at latest GA week 15+0) to delivery)
- Physical activity behavior changes among pregnant women(At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery)
- Motivation for physical activity among pregnant women(At inclusion, GA week 28+0-6, GA week 34+0-6 and one year after delivery)
- Personal understandings of physical activity in everyday life - by observations(From inclusion (at latest GA week 15+0) to delivery)
- A process evaluation of FitMum RCT interventions(From inclusion (at latest GA week 15+0) to delivery)
研究者
Ellen Christine Leth Loekkegaard
Professor, Chief Physician, PhD
Nordsjaellands Hospital
