A pilot randomized controlled trial of increased sleep opportunity on glucose tolerance, weight gain and body composition parameters in pregnancy
Not Applicable
- Conditions
- PregnancyReproductive Health and Childbirth - Normal pregnancy
- Registration Number
- ACTRN12616001209482
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. [Birth of child, with option to withdraw at end of second trimester. ];Gestational weight gain as measured by calibrated digital scales. [Pre-Pregnancy (self-reported), 12-15, 18, 22, 25,28,31,36-37 weeks gestation and birth];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.<br>[ 12-15, 18, 22, 25,28,31,36-37 weeks gestation]
- Secondary Outcome Measures
Name Time Method Foetal adiposity measured via ultrasound [22 and 36 weeks gestation ]