Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001209482p
Ethics application status
Submitted, not yet approved
Date submitted
30/08/2016
Date registered
1/09/2016
Date last updated
1/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomized controlled trial of increased sleep opportunity on glucose tolerance, weight gain and body composition parameters in pregnancy
Scientific title
A pilot randomized controlled trial of increased sleep opportunity on glucose tolerance, weight gain and body composition parameters in pregnancy
Secondary ID [1] 290056 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 300109 0
Condition category
Condition code
Reproductive Health and Childbirth 299993 299993 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295778 0
Lifestyle
Comparator / control treatment
Women allocated to the control group will receive a brief, single written resource based on the generic Australian Dietary and Physical Activity Guidelines with no further support provided from the research team. All other standard antenatal care guidelines will continue.
Control group
Active

Outcomes
Primary outcome [1] 299473 0
Feasibility of the sleep program, this will be assessed by the retention rate of participants and compliance to sleep intervention as measured by actigraphy and sleep diaries.
Timepoint [1] 299473 0
Birth of child, with option to withdraw at end of second trimester.
Primary outcome [2] 299474 0
Gestational weight gain as measured by calibrated digital scales.
Timepoint [2] 299474 0
Pre-Pregnancy (self-reported), 12-15, 18, 22, 25,28,31,36-37 weeks gestation and birth
Primary outcome [3] 299475 0
Maternal glucose tolerance as measured by standard care oral glucose tolerance test and 7 fasting glucose and insulin extracted from finger prick sample and plasma analysed via ELISA.
Timepoint [3] 299475 0
12-15, 18, 22, 25,28,31,36-37 weeks gestation
Secondary outcome [1] 327290 0
Foetal adiposity measured via ultrasound
Timepoint [1] 327290 0
22 and 36 weeks gestation

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will be randomized centrally, however as this is a pilot study it will not be blinded
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/09/2016
Actual
Date of last participant enrolment
Anticipated
1/02/2018
Actual
Date of last data collection
Anticipated
29/08/2018
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6575 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 14181 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 294423 0
University
Name [1] 294423 0
Monash University
Country [1] 294423 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd & Blackburn Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 293273 0
None
Name [1] 293273 0
None
Address [1] 293273 0
None
Country [1] 293273 0
Other collaborator category [1] 279185 0
Hospital
Name [1] 279185 0
Monash Medical Centre
Address [1] 279185 0
246 Clayton Road Clayton VIC 3168
Country [1] 279185 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295848 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 295848 0
246 Clayton Road Clayton VIC 3168
Ethics committee country [1] 295848 0
Australia
Date submitted for ethics approval [1] 295848 0
20/07/2016
Approval date [1] 295848 0
Ethics approval number [1] 295848 0
16368A

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68698 0
Dr Michelle Blumfield
Address 68698 0
Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill, Victoria 3168
Country 68698 0
Australia
Phone 68698 0
+61 3 9902 4270
Fax 68698 0
Email 68698 0
[email protected]
Contact person for public queries
Name 68699 0
Michelle Blumfield
Address 68699 0
Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill, Victoria 3168
Country 68699 0
Australia
Phone 68699 0
+61 3 9902 4270
Fax 68699 0
Email 68699 0
[email protected]
Contact person for scientific queries
Name 68700 0
Michelle Blumfield
Address 68700 0
Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill, Victoria 3168
Country 68700 0
Australia
Phone 68700 0
+61 3 9902 4270
Fax 68700 0
Email 68700 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Plain language summaryNo The intervention was not considered feasible due t... [More Details]

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