ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pregnancy

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

Birth of child, with option to withdraw at end of second trimester.

Primary outcome [2]

Gestational weight gain as measured by calibrated digital scales.

Timepoint [2]

Pre-Pregnancy (self-reported), 12-15, 18, 22, 25,28,31,36-37 weeks gestation and birth

Primary outcome [3]

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]

12-15, 18, 22, 25,28,31,36-37 weeks gestation

Secondary outcome [1]

Foetal adiposity measured via ultrasound

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Wellington Rd & Blackburn Rd, Clayton VIC 3800

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Rd & Blackburn Rd, Clayton VIC 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Monash Medical Centre

Address [1]

246 Clayton Road Clayton VIC 3168

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

246 Clayton Road Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/07/2016

Approval date [1]

Ethics approval number [1]

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

Dr Michelle Blumfield

Address

Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill, Victoria 3168

Country

Australia

Phone

+61 3 9902 4270

Fax

michelle.blumfield@monash.edu

Contact person for public queries

Name

Michelle Blumfield

Address

Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill, Victoria 3168

Country

Australia

Phone

+61 3 9902 4270

Fax

michelle.blumfield@monash.edu

Contact person for scientific queries

Name

Michelle Blumfield

Address

Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill, Victoria 3168

Country

Australia

Phone

+61 3 9902 4270

Fax

michelle.blumfield@monash.edu

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

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		The intervention was not considered feasible due t... [More Details]

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No additional documents have been identified.

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