Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001165572p
Ethics application status
Not yet submitted
Date submitted
11/09/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity advice during pregnancy by an Accredited Exercise Physiologist
Scientific title
Effect of Physical Activity Advice during Antenatal Visits on Changes in Weight, Health and Wellness in Pregnant Women
Secondary ID [1] 312943 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 335113 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331616 331616 0 0
Other physical medicine / rehabilitation
Reproductive Health and Childbirth 331680 331680 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive education materials and guidance on effective exercise during pregnancy, including recommended types of exercise, intensity levels, and duration. The advice will be provided in the form of a one-on-one consultation with an Accredited Exercise Physiologist (AEP). Participants will be invited to attend AEP consultations either face-to-face at the hospital or via zoom, as such the timing and attendance between participants will vary. It is hoped that participants will attend 7 to 10 AEP consults. The consults will last for approximately 20-30 minutes. The initial session with the AEP will incorporate educational materials, pre-pregnancy exercise participation and exercise participation since pregnancy. The education materials will be designed specifically for this study. In the weekly and monthly telehealth sessions, The AEP will encourage participants to meet the physical activity guidelines according to the Australian Government - Department of Health and Aged Care guidelines (updated 2021). The advice will be individualised to each participants health concerns, conditions, interests and available equipment, as per a standard AEP consultation. However will broadly include recommendations for being active most days of the week, with a weekly total up to 5 hours of moderate intensity exercise or 2.5 hours of vigorous intensity exercise (or an equivalent combination of both). Muscle strengthening exercises will also be recommended at least 2 days each week. Adherence to the intervention will be assessed by a session attendance checklist.
Intervention code [1] 329476 0
Lifestyle
Comparator / control treatment
The control group will receive no exercise advice or resources from the AEP. They will continue to receive usual care from their health providers, which may include exercise advice as per a standard antenatal appointment.
Control group
Active

Outcomes
Primary outcome [1] 339348 0
Weight gain
Timepoint [1] 339348 0
pre-pregnancy and term
Secondary outcome [1] 439611 0
Maternal and perinatal morbidity composite score
Timepoint [1] 439611 0
Birth
Secondary outcome [2] 439612 0
Exercise capacity
Timepoint [2] 439612 0
Upon enrolment and week 35-37 gestation
Secondary outcome [3] 439613 0
Physical activity
Timepoint [3] 439613 0
Upon enrolment and week 35-37 gestation
Secondary outcome [4] 439808 0
Grip strength
Timepoint [4] 439808 0
Upon enrolment and week 35-37 gestation

Eligibility
Key inclusion criteria
Pregnant and presenting to RWBH antenatal department.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Standard absolute contraindications to exercise in pregnancy
o Severe respiratory diseases (e.g., chronic obstructive pulmonary disease, restrictive lung disease and cystic fibrosis)
o Severe acquired or congenital heart disease with exercise intolerance
o Uncontrolled or severe arrhythmia
o Placental abruption
o Vasa previa
o Uncontrolled type 1 diabetes
o Intrauterine growth restriction (IUGR)
o Active preterm labour
o Severe pre-eclampsia
o Cervical insufficiency

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)
That is, an external party with no association to the present study or the topic, will randomly assign participants to each group using a random generator. The research team will be made aware of the allocation of each participant following assignment to either group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
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
20/01/2025
Actual
Date of last participant enrolment
Anticipated
2/01/2026
Actual
Date of last data collection
Anticipated
11/09/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317378 0
University
Name [1] 317378 0
Australian Catholic University
Country [1] 317378 0
Australia
Funding source category [2] 317443 0
Hospital
Name [2] 317443 0
Royal Brisbane and Women's Hospital
Country [2] 317443 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 319668 0
None
Name [1] 319668 0
Address [1] 319668 0
Country [1] 319668 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316107 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 316107 0
Ethics committee country [1] 316107 0
Australia
Date submitted for ethics approval [1] 316107 0
02/10/2024
Approval date [1] 316107 0
Ethics approval number [1] 316107 0

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

Contacts
Principal investigator
Name 136806 0
Dr Kassia Beetham
Address 136806 0
Australian Catholic University, 1100 Nudgee Road, Banyo, QLD 4014
Country 136806 0
Australia
Phone 136806 0
+61738616141
Fax 136806 0
Email 136806 0
kassia.beetham@acu.edu.au
Contact person for public queries
Name 136807 0
Kassia Beetham
Address 136807 0
Australian Catholic University, 1100 Nudgee Road, Banyo, QLD, 4014
Country 136807 0
Australia
Phone 136807 0
+61738616141
Fax 136807 0
Email 136807 0
kassia.beetham@acu.edu.au
Contact person for scientific queries
Name 136808 0
Kassia Beetham
Address 136808 0
Australian Catholic University, 1100 Nudgee Road, Banyo, QLD, 4014
Country 136808 0
Australia
Phone 136808 0
+61738616141
Fax 136808 0
Email 136808 0
kassia.beetham@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.