Trial Review

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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.
Scientific title
Assessment of pregnant women undertaking daily weighing, compared to standard care, in gaining target pregnancy weight gain.
Secondary ID [1] 283404 0
Exercise and Daily Weight Monitoring in Pregnancy - A
Randomised Controlled Trial
Universal Trial Number (UTN)
U1111-1149-1500
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy weight gain 290311 0
Condition category
Condition code
Reproductive Health and Childbirth 290708 290708 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288129 0
Behaviour
Comparator / control treatment
Routine antenatal care - weight recorded at 20 weeks, 36 weeks and at delivery if possible
Control group
Active

Outcomes
Primary outcome [1] 290713 0
Achievement of target pregnancy weight gain, as a continuous outcome variable (ie percent difference from target weight gain)
Timepoint [1] 290713 0
At the end of the pregnancy
Secondary outcome [1] 305078 0
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).
Timepoint [1] 305078 0
End of pregnancy
Secondary outcome [2] 305097 0
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.
Timepoint [2] 305097 0
Assessed after delivery

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1593 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 7467 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 288126 0
Hospital
Name [1] 288126 0
Redcliffe Hospital Private Practice Trust Fund
Country [1] 288126 0
Australia
Primary sponsor type
Individual
Name
Dr Shaun McGrath
Address
Redcliffe Hospital, Anzac Ave, Redcliffe, QLD 4020
Country
Australia
Secondary sponsor category [1] 286853 0
None
Name [1] 286853 0
Address [1] 286853 0
Country [1] 286853 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290049 0
Human Research Ethics Committee, Metro North Hospital and Health Service
Ethics committee address [1] 290049 0
The Prince Charles Hospital
Administration Building, Lower Ground
Rode Road, Chermside QLD 4032
Ethics committee country [1] 290049 0
Australia
Date submitted for ethics approval [1] 290049 0
Approval date [1] 290049 0
12/09/2013
Ethics approval number [1] 290049 0
HREC/13/QPCH/187

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43210 0
Dr Shaun McGrath
Address 43210 0
Redcliffe Hospital
Anzac Ave
Redcliffe Q 4020
Country 43210 0
Australia
Phone 43210 0
+61 7 3883 7116
Fax 43210 0
Email 43210 0
s.mcgrath@uq.edu.au
Contact person for public queries
Name 43211 0
Dr Shaun McGrath
Address 43211 0
Redcliffe Hospital
Anzac Ave
Redcliffe Q 4020
Country 43211 0
Australia
Phone 43211 0
+61 7 3883 7116
Fax 43211 0
Email 43211 0
s.mcgrath@uq.edu.au
Contact person for scientific queries
Name 43212 0
Dr Shaun McGrath
Address 43212 0
Redcliffe Hospital
Anzac Ave
Redcliffe Q 4020
Country 43212 0
Australia
Phone 43212 0
+61 7 3883 7116
Fax 43212 0
Email 43212 0
s.mcgrath@uq.edu.au

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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