None listed
Conditions
Brief summary
Babies with low birth weight, thinness or short body length at birth have increased risk of cardiovascular disease and Type 2 Diabetes in adult life. The foetal origins hypothesis suggests that these diseases originate through changes that the foetus makes during pregnancy when it is undernourished. These changes can permanently alter the structure and function of the developing body. Prevention of these diseases may depend on optimising foetal growth and nutrient supply to the foetus. Sleep can alter energy balance. Short sleep (<7 hrs) during pregnancy has been linked to higher rates of caesarean section, preterm birth, intrauterine growth restriction, risk of gestational diabetes mellitus and postnatal depression. No research has examined the relationship between sleep, diet and maternal child weight related outcomes or tested the benefits of increasing sleep opportunity in pregnancy. The aim of this study is to test the benefits of increasing sleep opportunity during pregnancy on maternal glucose tolerance, gestational weight gain and foetal body composition from 12 to 37 weeks gestation in a randomised controlled trial. Pregnant women booked to deliver at the Monash Medical Centre Clayton will be randomised to: (i) Intervention group: night sleep opportunity increased to 10hr time in bed, with tailored advice around sleep practices; or (ii) Control group: normal sleep patterns. After a 1week baseline period, women will be evaluated seven times during pregnancy from 12 weeks gestation (i.e. at 12,18,22,25,28,31 and 37 weeks). Sleep data will be collected using Inhome Electroencephalography Sleep Monitoring. Adherence to the intervention will be monitored through Actigraphy and sleep diaries. Glucose tolerance, gestational weight gain and foetal body composition will be measured at each visit. This is the first RCT to test the effect of increased sleep opportunity in pregnancy. Findings will provide high quality evidence for the effect of sleep in pregnancy on important prenatal predictors of maternal and child obesity, a noval insight into the feasibility of increasing sleep in pregnancy and a cost effective intervention to improve sleep practices.
Interventions
This study will utilise a randomised controlled trial design. The study will compare whether increased sleep opportunity (10 hours time in bed each night >5 days per week from enrollment to delivery, with the option to opt out after the second trimester) during pregnancy, compared to normal sleep practices, promotes favourable maternal and child weight related outcomes. Subjects will be randomised to either follow a night intervention during pregnancy or continue their normal sleep patterns. An
This study will utilise a randomised controlled trial design. The study will compare whether increased sleep opportunity (10 hours time in bed each night >5 days per week from enrollment to delivery, with the option to opt out after the second trimester) during pregnancy, compared to normal sleep practices, promotes favourable maternal and child weight related outcomes. Subjects will be randomised to either follow a night intervention during pregnancy or continue their normal sleep patterns. An initial one week baseline period will allow for assessment of usual sleep patterns, activity, diet and glucose tolerance. Women allocated to the intervention group will be required to increase their sleep opportunity each night to 10 hours time in bed without exposure to bright light. Participants will be provided with a dim light should they need to get up in the night (e.g. go to the toilet). Participants will also receive information to improve sleep strategies with the following core components: (a) general information and skills for better sleep (e.g. sleep hygiene, relaxation and mindfulness exercises, dealing with night time worries, how to maintain a healthy light environment); (b) fostering healthy attitudes and expectations about sleep during the perinatal periods; (c) managing sleep challenges specific to the perinatal periods (e.g. physical discomfort, pain, daytime consequences of poor sleep). Intervention materials have been adapted from those developed by Dr Sean Cain to maximise treatment outcomes and promote sustainable integration with Monash Health maternity care. Sleep data will be collected using In home Electroencephalography Sleep Monitoring. Adherence to the intervention will be monitored through Actigraphy and sleep diaries.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Women aged 18-45 years, <15 weeks gestation, with non-complicated singleton pregnancy, receiving antenatal care at Monash Medical Center (Clayton, Victoria) with no implanted electrical devices and primary language is English.
Exclusion criteria
Women <18 or >45 years old, women with complicated pregnancies, drug or alcohol use during pregnancy, smokers, cognitive impairment, intellectual disability or a mental illness and women who's primary language is other than English.
Outcome results
None listed