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Trial registered on ANZCTR
Registration number
ACTRN12613001165774
Ethics application status
Approved
Date submitted
17/10/2013
Date registered
23/10/2013
Date last updated
23/10/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
A Randomised Controlled Trial of Daily Weighing in Pregnancy to Control Gestational Weight Gain, Incorporating Self-Reported Activity Levels of Pregnant Women Presenting to a Secondary Level Maternity Unit.
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Scientific title
Assessment of pregnant women undertaking daily weighing, compared to standard care, in gaining target pregnancy weight gain.
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Secondary ID [1]
283404
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Exercise and Daily Weight Monitoring in Pregnancy - A
Randomised Controlled Trial
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Universal Trial Number (UTN)
U1111-1149-1500
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pregnancy weight gain
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Condition category
Condition code
Reproductive Health and Childbirth
290708
290708
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0
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Antenatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental group will be allocated a set of bathroom scales and asked to weigh themselves daily through the second half of the pregnancy, recording the weight each day. These women will also be weighed at about 20 weeks, at 36 weeks and at delivery if possible.
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Intervention code [1]
288129
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Behaviour
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Comparator / control treatment
Routine antenatal care - weight recorded at 20 weeks, 36 weeks and at delivery if possible
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Control group
Active
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Outcomes
Primary outcome [1]
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Achievement of target pregnancy weight gain, as a continuous outcome variable (ie percent difference from target weight gain)
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Assessment method [1]
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Timepoint [1]
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At the end of the pregnancy
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Secondary outcome [1]
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Pre-pregnancy, mid-pregnancy and end of pregnancy exercise levels, assessed using the Kaiser Physical Activity Scale questionnaire (participants will retrospectively complete their pre-pregnancy questionnaire at the same time as the mid-pregnancy questionnaire).
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Assessment method [1]
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Timepoint [1]
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End of pregnancy
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Secondary outcome [2]
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Other pregnancy and neonatal outcomes including mode of delivery, blood loss, fetal complications etc will be obtained from the participant's medical record, their baby's record and perinatal database.
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Assessment method [2]
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Timepoint [2]
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Assessed after delivery
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Eligibility
Key inclusion criteria
Singleton pregnancy
Non-smoker
No previous bariatric surgery
No type 1 or 2 diabetes mellitus
Proficient in English
No pre-existing renal disease or hypertension
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Multiple pregnancy
Smoker
Previous bariatric surgery
Type 1 or 2 diabetes
Lack of proficiency in English
Pre-existing renal disease or hypertension
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment is through antenatal clinic. Once enrolled, patient will be directed to a midwife who will allocate a sequential, sealed opaque envelope with the randomisation to experimental or control group inside.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequentially numbered, opaque sealed envelopes (SNOSE) technique outlined in http://www.ncbi.nlm.nih.gov/pubmed/16139163
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
A study with a continuous outcome variable (i.e. per cent difference from target weight) requires a sample of 142 in each group to achieve 80% power with an alpha level of 0.05 using a t-test with a mean difference of 10% and an estimated standard deviation of 30%. A 15% correction has been applied to account for potential non-normal distribution of the outcome variable (allowing analysis by a Mann-Whitney U test), equating to a minimum of 164 patients required in each group. We therefore plan to recruit 200 participants to each arm of the study.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/10/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Redcliffe Hospital - Redcliffe
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Recruitment postcode(s) [1]
7467
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4020 - Redcliffe
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Redcliffe Hospital Private Practice Trust Fund
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Address [1]
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Redcliffe Hospital, Anzac Ave, Redcliffe QLD 4020
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Country [1]
288126
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Australia
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Primary sponsor type
Individual
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Name
Dr Shaun McGrath
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Address
Redcliffe Hospital, Anzac Ave, Redcliffe, QLD 4020
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
286853
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Country [1]
286853
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee, Metro North Hospital and Health Service
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Ethics committee address [1]
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The Prince Charles Hospital Administration Building, Lower Ground Rode Road, Chermside QLD 4032
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
290049
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Approval date [1]
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12/09/2013
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Ethics approval number [1]
290049
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HREC/13/QPCH/187
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Summary
Brief summary
The research aim is to ascertain the activity levels of pregnant women who present for antenatal care to a secondary maternity unit as they progress through their pregnancy, and the effect of daily weight monitoring on gestational weight gain. This RCT will determine whether daily selfmonitoring of weight has a beneficial effect on achieving target maternal gestational weight gain, and will explore factors which influence the amount of weight gained during the pregnancy, including dietary advice, selfreported exercise, socioeconomic status and ethnicity. The study is a randomized controlled trial. All patients presenting at 14-20 weeks for antenatal care at Redcliffe Hospital would be eligible for enrollment. Consent will be obtained by a treating clinician at the medical booking in visit (approximately 20 weeks gestation), with participants randomised to one of two groups (daily measurement group and nondaily measurement group). Consent will include the postnatal collection of data pertaining to the health of the mother and the neonate. Exclusion criteria shall include lack of proficiency in English, preexisting diabetes, preexisting hypertension, preexisting renal disease, multiple pregnancies, minors under 18 years of age. Participants and clinicians would be blinded to treatment allocation. Dietary and exercise advice is standardized and comprised of published Australian exercise and dietary guidelines. This information is to be provided in handout form at the visit at which the participant is enrolled, and referred to at each subsequent visit. Those patients in the treatment arm shall also be provided with a set of scales and a record book in which they are to log their weight daily. They shall be provided with instruction to weigh themselves as close to the same time each day as possible. Clinicians are to weigh the participants at the booking in visit (approximately 20 weeks gestation), the 36 week visit and as close to delivery as possible (eg when comes into labour in birth suite). In addition, women will be asked for their prepregnancy weight which is routinely recorded in the pregnancy health record. At enrollment and at the 36/40 summation visit, participants in both treatment groups complete a Kaiser Physical Activity Survey, to assess their levels of activity. At the enrollment visit, they shall also complete a KPAS retrospectively assessing their pre pregnancy activity levels.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Shaun McGrath
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Address
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Redcliffe Hospital
Anzac Ave
Redcliffe Q 4020
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Country
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Australia
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Phone
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+61 7 3883 7116
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Shaun McGrath
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Address
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Redcliffe Hospital
Anzac Ave
Redcliffe Q 4020
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Country
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Australia
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Phone
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+61 7 3883 7116
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Shaun McGrath
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Address
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Redcliffe Hospital
Anzac Ave
Redcliffe Q 4020
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Country
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Australia
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Phone
43212
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+61 7 3883 7116
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Fax
43212
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Email
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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