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Trial registered on ANZCTR


Registration number
ACTRN12618000159257
Ethics application status
Approved
Date submitted
26/01/2018
Date registered
1/02/2018
Date last updated
1/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
My Exercise My offspring (MEMO) study: a randomised controlled trial to evaluate the effectiveness of a physical activity program for pregnant women
Scientific title
My Exercise My offspring (MEMO) study: a randomised controlled trial to assess the effects of a physical activity intervention for pregnant women on pregnancy outcomes and exercise levels post-partum.
Secondary ID [1] 292266 0
None
Universal Trial Number (UTN)
U1111-1198-2841
Trial acronym
MEMO study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 303785 0
Pregnancy 303786 0
Condition category
Condition code
Metabolic and Endocrine 303155 303155 0 0
Diabetes
Reproductive Health and Childbirth 303157 303157 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women up to 18+6 weeks of gestation that present to the Liverpool Hospital antenatal clinic will be provided with the MEMO Flyer, MEMO Participant Information Document, and the PADIP (Physical Activity and Diet in Pregnancy) Questionnaire. The PADIP Questionnaire will also be available via Surveymonkey The flyer will instruct interested women to indicate their wish to participate in this study by either completing the flyer and returning it to the Liverpool Hospital antenatal clinic MEMO box, or sending an email to the investigator as described on the flyer. A set of questions addressing the inclusion and exclusion criteria will be included as part of the PADIP Questionnaire. At the end of the PADIP questionnaire, the women will be invited to read through a detailed explanation of what the MEMO study involves, how the randomisation process works, as well as the risks and benefits of participating in the study. Subsequently, women will be asked to provide consent electronically and a paper version of the consent form will be provided to women without access to the internet. Using information from the PADIP Questionnaire as well as existing medical records, all participants will be assessed for medical and obstetrical factors that may increase their risk for maternal/foetal complications and/or injuries prior to randomisation. Women that fulfil inclusion criteria and consent to participation in the study will be randomised to either the exercise intervention or usual antenatal care. Women will be asked to indicate whether they would like surveys to be sent via email or to be provided as hard copies (provided during antenatal clinic appointment or posted to their address).

Consent: all participants will be required to provide informed consent electronically as approved by the South Western Sydney Local Health District Human Research Ethics Committee.
Randomisation: randomisation sequence will be created with a computer random number generator with a 1:1 allocation using random block sizes of 2 and 4. The allocation sequence will be concealed from staff enrolling and assessing participants by using sequentially numbered, opaque, sealed and stapled envelopes.
Blinding: the nature of this study means that care providers and participants will not be blinded to the intervention allocation. Outcome assessors will be blinded to the intervention allocation.

Experimental intervention:
Participants in the intervention group will be given the "My Steps Diary" which contains instructions at the front of the booklet for the home/community-based walking program.
Women in the intervention group will be invited to engage in moderate intensity walking in their own time at home or in the community as decided by the participant.
The duration of the walking intervention will be gradually increased to eventually reach the target of walking at a moderate intensity (roughly 70-100 steps/min) for 30 mins or greater as tolerated on 5-7 days of the week. Due to individual differences, women will be encouraged to aim for moderate intensity walking that is brisk and increases the heart rate and breathing rate but should still allow a normal conversation to be held. Women should only exercise as tolerated and in a cool environment.
• walk for around 15 mins at a moderate intensity on 3-4 days per week during week 1 and 2 of the intervention
• walk for around 15 mins at a moderate intensity on 5-7 days per week during week 3 and 4 of the intervention
• walk for around 15 mins and 30 mins alternately at a moderate intensity on 5-7 days per week during week 5 and 6 of the intervention
• walk for around 30 mins (or greater as tolerated) at a moderate intensity on 5-7 days per week thereafter as tolerated. Participants may accumulate episodes of exercises greater than 10 mins to reach the target of 30 mins on 5-7 days of the week.

Compliance aid: Women in the intervention group will be sent a link to download a pedometer app (Accupedo) onto their mobile phones. These women will be advised to use the app to record the total distance walked and number of steps taken during the day. The distance walked and number of steps taken during time specifically set aside for physical activity will also be recorded separately. It is proposed that the pedometer app will motivate women to attain their target level of physical activity, and also encourage self-efficacy in monitoring physical activity.

Women will be asked to document the distance, number of steps walked daily, and the time spent walking in a "My Steps Diary".

At 24-26 weeks of gestation and 34-36 weeks of gestation, women will be asked to complete a survey to determine average amounts of time spent exercising per week. For women choosing to complete the surveys online, the surveys will be emailed to the participants by the principal investigator. Hard copies of the surveys will be provided by the treating clinician/midwife to participants without email access.

The Edinburgh Postnatal Depression Scale will be administered at 24-26 weeks of gestation and again at 34-36 weeks of gestation. Hard copies of the surveys will be provided by the treating clinician/midwife to all participants during their antenatal clinic appointment.

Patient satisfaction assessed using the MEMO Study Patient Satisfaction Survey to be administered at 8-10 weeks postpartum. For women choosing to complete the surveys online, the surveys will be emailed to the participants by the principal investigator. Hard copies of the surveys will be posted to participants without email access.

At 6 months and 1 year postpartum, participants will be sent a survey to evaluate exercise habits and patterns. For women choosing to complete the surveys online, the surveys will be emailed to the participants by the principal investigator. Hard copies of the surveys will be posted to participants without email access.
Intervention code [1] 298443 0
Prevention
Intervention code [2] 298444 0
Lifestyle
Comparator / control treatment
Participants in the control group will receive usual antenatal care. Usual antenatal care will involve standard care provided by Liverpool Hospital antenatal clinic staff for pregnant women as per local policies and protocols.

Additionally, the women in the control group will be asked to complete the following:

1) At 24-26 weeks of gestation and 34-36 weeks of gestation, women will be asked to complete a survey to determine average amounts of time spent exercising per week.

2) The Edinburgh Postnatal Depression Scale will be administered at 24-26 weeks of gestation and again at 34-36 weeks of gestation.

3) At 6 months and 1 year postpartum, participants will be sent a survey to evaluate exercise habits and patterns.
Control group
Active

Outcomes
Primary outcome [1] 302525 0
Primary maternal outcome:
• incidence of Gestational Diabetes Mellitus (GDM). The IADPSG criteria for GDM will be used: a fasting glucose level greater than or equal to 5.1 mmol/L (92 mg/dL), a glucose level greater than or equal to 10.0 mmol/L (180 mg/dL) 1-hr after a 75g oral glucose load, or a glucose level greater than or equal to 8.5 mmol/L (153 mg/dL) 2-hrs after a 75g oral glucose load. A diagnosis of GDM will be made when one or more of these criteria are fulfilled.
Timepoint [1] 302525 0
Women considered to be at high risk of GDM will be screened with a 75g oral glucose tolerance test (OGTT) at ideally 12-14 weeks of gestation (but will perform screening at up to 18+6 weeks for women recruited later than 12-14 weeks) with repeat testing at 26-28 weeks. The remaining women will be screened with a 75g OGTT at 26-28 weeks of gestation.
Primary outcome [2] 302526 0
Primary neonatal outcome:
• macrosomia (birth weight greater than or equal to 4000g)

Birth weight will be obtained from the medical records
Timepoint [2] 302526 0
At delivery
Secondary outcome [1] 336288 0
Physical activity level (composite outcome): distance walked and number of steps taken weekly as part of the walking program will be measured by participants using the Accupedo mobile phone app and recorded by participants in the "My Steps Diary".
Timepoint [1] 336288 0
At the completion of pregnancy as well as 6 months and 1 year postpartum.
Secondary outcome [2] 336289 0
Percentage of participants with GDM requiring pharmacological treatment.

Data will be collected from the medical records.
Timepoint [2] 336289 0
At the completion of the pregnancy.
Secondary outcome [3] 336290 0
Gestational weight gain (kg)

Pre-pregnancy weight will be recorded at the first antenatal clinic visit. The first recorded pregnancy weight will be compared with the participant's self reported pre-pregnancy weight. If there is a significant difference between the first recorded pregnancy weight and the participant's self reported pre-pregnancy weight, the earliest pregnancy weight will be used. Maternal weights will be measured at every antenatal clinic visit and the gestational weight gain will be calculated by subtracting the first recorded pregnancy weight from the final weight measured at or after 36 weeks and as close as possible to delivery.
Timepoint [3] 336290 0
At the completion of the pregnancy.
Secondary outcome [4] 336291 0
Incidence of labour induction

Data will be collected from the medical records
Timepoint [4] 336291 0
At completion of the pregnancy
Secondary outcome [5] 336292 0
Mode of delivery: Caesarean delivery, operative vaginal delivery, unassisted vaginal delivery.

Data will be collected from the medical records
Timepoint [5] 336292 0
At completion of pregnancy.
Secondary outcome [6] 336293 0
Incidence of third or fourth degree tears.

Data will be collected from the medical records
Timepoint [6] 336293 0
At delivery
Secondary outcome [7] 336294 0
Incidence of pre-eclampsia.

Data will be collected from the medical records
Timepoint [7] 336294 0
At delivery.
Secondary outcome [8] 336295 0
Incidence of placental abruption.

Data will be collected from the medical records.
Timepoint [8] 336295 0
At delivery.
Secondary outcome [9] 336296 0
Incidence of postpartum haemorrhage.

Data will be collected from the medical records.
Timepoint [9] 336296 0
From delivery up to 6 weeks postpartum.
Secondary outcome [10] 336297 0
Glycated haemoglobin (HbA1c) measured in women with GDM.

Data will be collected from the medical records.
Timepoint [10] 336297 0
At 36-38 weeks of gestation in women with GDM.
Secondary outcome [11] 336298 0
Neonatal anthropometric measurements (composite outcome): neonatal length, head circumference, abdominal circumference, mid-upper arm circumference
Timepoint [11] 336298 0
Within 72 hours of delivery
Secondary outcome [12] 336299 0
Neonatal hypoglycaemia <2.6mmol/L.

Data will be collected from the medical records.
Timepoint [12] 336299 0
In the first 24 hours of after delivery.
Secondary outcome [13] 336300 0
Mean birthweight (grams).

Data will be collected from the medical records.
Timepoint [13] 336300 0
At delivery.
Secondary outcome [14] 336301 0
Prevalence of large-for-gestational-age infants (birth weight >97th percentile or 4500g at term).

Data will be collected from the medical records.
Timepoint [14] 336301 0
At delivery.
Secondary outcome [15] 336302 0
Prevalence of small-for-gestational-age infants (birth weight <10th percentile).

Data will be collected from the medical records.
Timepoint [15] 336302 0
At delivery.
Secondary outcome [16] 336303 0
Gestational age at birth.

Data will be collected from the medical records.
Timepoint [16] 336303 0
At completion of pregnancy.
Secondary outcome [17] 336304 0
Incidence of preterm birth (<37 weeks gestation).

Data will be collected from the medical records.
Timepoint [17] 336304 0
At delivery.
Secondary outcome [18] 336305 0
Composite neontal outcome including birth trauma, shoulder dystocia, admission to NICU, hyperbilirubinaemia, need for phototherapy, respiratory distress syndrome, need for ventilation, congenital anomalies, perinatal death.

Data will be collected from the medical records.
Timepoint [18] 336305 0
At 4 weeks postpartum.
Secondary outcome [19] 342445 0
Participant satisfaction as assessed using the MEMO Study Participant Satisfaction Survey
Timepoint [19] 342445 0
8-10 weeks postpartum
Secondary outcome [20] 342446 0
Mood as assessed using the Edinburgh Postnatal Depression Scale
Timepoint [20] 342446 0
The Edinburgh Postnatal Depression Scale will be administered at 24-26 weeks of gestation and again at 34-36 weeks of gestation.
Secondary outcome [21] 342537 0
Gestational hypertension. Gestational hypertension is defined as new onset of hypertension ( systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg) after 20 weeks of gestation in the absence of features to suggest pre-eclampsia

Data will be collected from medical records
Timepoint [21] 342537 0
At delivery

Eligibility
Key inclusion criteria
• Women aged 18 yrs and over
• Up to 18+6 weeks of gestation
• Able to speak, understand and read English fluently
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of incompetent cervix/cerclage
• At increased risk of preterm birth #
• Multiple gestation
• Type 1 or type 2 diabetes
• Previous GDM
• Haemodynamically significant heart disease
• Unevaluated maternal cardiac arrhythmias
• Restrictive lung disease, chronic bronchitis, or other chronic respiratory diseases
• Anaemia where Hb <90g/L
• Poorly controlled hypertension
• Poorly controlled seizure disorders
• Poorly controlled hyperthyroidism
• Orthopaedic limitations
• Any other poorly controlled medical disorder
• Women participating in any other trial or study should notify the MEMO investigators and will not be eligible for inclusion in this study unless advised otherwise

# Previous spontaneous preterm birth is not listed as an absolute or relative contraindication to exercise during pregnancy as per the ACOG guidelines. Most women with a history of spontaneous preterm birth should be able to engage in moderate intensity exercise for at least 30 minutes on most days of the week (as recommended by the RANZCOG and ACOG guidelines) as long as they receive regular antenatal care and follow the instructions of their midwife and doctor. Women with a history of spontaneous preterm birth will be excluded if they have a history of incompetent cervix/cerclage, abnormalities of the uterus/cervix/placenta/fetus that would be a contraindication to exercise during pregnancy, or if they meet any other exclusion criteria.

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)
The allocation sequence will be concealed from staff enrolling and assessing participants by using sequentially numbered, opaque, sealed and stapled envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be created with a computer random number generator with a 1:1 allocation using random block sizes of 2 and 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:

Based on the results from the study by Tomic et al. (40), a sample size of 207 participants in each group would be required to detect a statistically significant difference in the incidence of GDM with a significance level of 0.05 and a statistical power of 0.8. Assuming a dropout rate of 10-15%, the target sample size would be 238 in each group. We aim to recruit 500 participants with 250 in each group.

Statistical analysis:

Data will be analysed using SPSS (IBM Corp. in Armonk, NY). Mean +/-SD or medians and interquartile ranges will be reported for continuous variables. Frequencies and percentages will be reported for categorical variables. Differences between groups will be compared using the independent sample t-test (provided that there is a normal distribution) for continuous variables, and the Pearson's chi-square test for categorical variables as appropriate. The relative risks and corresponding 95% confidence intervals will be calculated. Analysis will be by intention to treat. A significance level of p<0.05 will be used.

(40): Tomic V, Sporiš G, Tomic J, Milanovic Z, Zigmundovac-Klaic D, Pantelic S. The effect of maternal exercise during pregnancy on abnormal fetal growth. Croatian Medical Journal. 05/21/received 05/15/accepted 2013;54(4):362-368.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/02/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8431 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 16503 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 296813 0
Hospital
Name [1] 296813 0
Liverpool Hospital Department of Obstetrics and Gynaecology
Country [1] 296813 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital Department of Obstetrics and Gynaecology
Address
Liverpool Hospital
Department of Obstetrics and Gynaecology
Locked Bag 7103
LIVERPOOL BC NSW 1871
Country
Australia
Secondary sponsor category [1] 297656 0
None
Name [1] 297656 0
Address [1] 297656 0
Country [1] 297656 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298048 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 298048 0
Ethics committee country [1] 298048 0
Australia
Date submitted for ethics approval [1] 298048 0
12/10/2017
Approval date [1] 298048 0
31/10/2017
Ethics approval number [1] 298048 0
2017001756 / HREC/17/LPOOL/410

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75814 0
Dr Xi May Zhen
Address 75814 0
Physician Training Unit
Royal Prince Alfred Hospital
Post Office Box M30 Missenden Road NSW 2050.
Country 75814 0
Australia
Phone 75814 0
+61 0422899893
Fax 75814 0
Email 75814 0
xi.zhen@uqconnect.edu.au
Contact person for public queries
Name 75815 0
Alan Adno
Address 75815 0
Feto-Maternal Unit
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC NSW 1871
Country 75815 0
Australia
Phone 75815 0
+61 02 87385631
Fax 75815 0
Email 75815 0
Alan.Adno@health.nsw.gov.au
Contact person for scientific queries
Name 75816 0
Alan Adno
Address 75816 0
Feto-Maternal Unit
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC NSW 1871
Country 75816 0
Australia
Phone 75816 0
+61 02 87385631
Fax 75816 0
Email 75816 0
Alan.Adno@health.nsw.gov.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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