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Trial registered on ANZCTR


Registration number
ACTRN12619001207101
Ethics application status
Approved
Date submitted
21/08/2019
Date registered
30/08/2019
Date last updated
18/06/2021
Date data sharing statement initially provided
30/08/2019
Date results provided
1/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a consumer co-created infographic improve knowledge and self-efficacy about physical activity for women with gestational diabetes mellitus?
Scientific title
Does the addition of a consumer co-created infographic to a gestational diabetes mellitus education class improve knowledge and self-efficacy about physical activity for women with gestational diabetes mellitus compared to an education class alone?
Secondary ID [1] 299010 0
Nil known
Universal Trial Number (UTN)
U1111-1238-6682
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes mellitus 314019 0
Condition category
Condition code
Metabolic and Endocrine 312409 312409 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: An infographic about physical activity for women with gestational diabetes mellitus (GDM) additional to the usual GDM Education class
Why: To improve knowledge and confidence about physical activity during a GDM pregnancy
What: An infographic co-developed by the research team and consumers. The infographic will be provided to consenting women attending a routine GDM Education class at the health service, so will be in addition to usual GDM education.
Who: A member of the research team, a physiotherapist with clinical and research expertise in women’s health, will provide the women with the infographic
How: The infographic will be in colour, in hard copy and provided to participating women individually
Where: GDM Education Class at the participating health service
When and how much: On one occasion (approximately 5 minutes) participants will be individually handed a hard copy of the infographic for them to take home and read before receiving the second survey approximately one week later.
Tailoring: not applicable
Modifications: The design and development of the infographic was completed in conjunction with women with GDM
How well: Not applicable
Intervention code [1] 315280 0
Lifestyle
Comparator / control treatment
Name: Usual GDM Education class
Why: To provide information about management of GDM
What: GDM Education.
Who: Diabetes Educator (nurse) and Dietitian
How: Information provided in the form of face to face, group, verbal education and supported by hard copy handouts of the information
Where: At the participating health service
When and how much: On one occasion
Tailoring: Not applicable
Modifications: Not applicable
How well: Not applicable
Control group
Active

Outcomes
Primary outcome [1] 321059 0
Knowledge of physical activity in a GDM pregnancy using a questionnaire about knowledge of physical activity during GDM. The knowledge questionnaire is based on a physical activity knowledge in adults questionnaire used by Morrow et al. (2004) and modified for this study to reflect current physical activity guidelines and physical activity in pregnancy guidelines.
Timepoint [1] 321059 0
Baseline and 1 week after exposure to the infographic intervention.
Primary outcome [2] 321060 0
Self-efficacy using the Physical Activity Self-efficacy Measure (PASEM)
Timepoint [2] 321060 0
Baseline and 1 week after exposure to the infographic intervention.
Secondary outcome [1] 373833 0
Nil
Timepoint [1] 373833 0
Nil

Eligibility
Key inclusion criteria
Participants will be included if they are:
a) Women diagnosed with GDM. The women are anticipated to be between approximately 20 weeks and 38 weeks gestation.
b) Women aged between 18 - 40 years.
c) Women with a singleton pregnancy.
d) Women able to express their thoughts in English.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are:
a) Women with a high-risk pregnancy or experiencing complications considered to be high-risk e.g. women at risk of premature labour, incompetent cervix, persistent bleeding, ruptured membranes, growth retardation, preeclampsia, severe anaemia, placenta previa after 26 weeks gestation, haemodynamically significant heart disease or restrictive lung disease will be excluded as exercise in pregnancy would be contraindicated in these conditions.
b) Women with conditions e.g. pregnancy-related pelvic girdle pain or pre-existing musculo-skeletal problems affecting their ability to exercise.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women are allocated to diabetes education group sessions by an independent outpatient department booking clerk and allocated according to the next available class. The researcher has no involvement in these bookings.
This will be a randomised controlled trial with GDM Education classes being randomly allocated to either the intervention or comparator. The randomisation will be performed using a computer generated randomisation and performed by an independent off-site person so as to conceal allocation. The holder of the allocation will then be contacted the day before a group so the researcher can be told the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of groups using a computer generated randomised sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This will be a randomised controlled trial with GDM Education classes being randomly allocated to either the intervention or comparator with evaluation at the level of the individual.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Convenience sampling will be used to recruit 60 women with GDM (30 women for a control group and 30 women for the intervention group). The a priori sample size calculation considered effect sizes for self-efficacy reported in previous studies. Based on a 0.05 level of significance, a power of 0.70 and a 0.6 effect size, a minimum of 27 participants is needed for each group. Allowing for 10% drop-outs, 30 participants will be recruited in each group.

Analysis: For the modified knowledge questionnaire the percentage of total correct will be calculated as well as for each of the two subscales, physical activity prescription (seven items) and recommended types of safe physical activity in pregnancy (twelve items).
The PASEM uses a rating scale of 1 to 10 for confidence in capability to exercise as per each statement. The difference in mean values between the infographic intervention and control group at 1 week will be evaluated with ANCOVA, using the baseline scores as a covariate and, if required, adding a covariate for day of the week of the group class.
Participant demographic data will be described using means and standard deviations (age, gestation, parity, BMI) or proportions (educational level, ethnicity).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2019
Actual
12/09/2019
Date of last participant enrolment
Anticipated
20/12/2019
Actual
19/11/2019
Date of last data collection
Anticipated
31/12/2019
Actual
3/12/2019
Sample size
Target
60
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14539 0
Werribee Mercy Hospital - Werribee
Recruitment postcode(s) [1] 27551 0
3030 - Werribee

Funding & Sponsors
Funding source category [1] 303545 0
Hospital
Name [1] 303545 0
Mercy Academic Research and Development Committee grant
Country [1] 303545 0
Australia
Primary sponsor type
Individual
Name
Anne Harrison
Address
Physiotherapy Department
Werribee Mercy Hospital
300 Princes Hwy
Werribee Victoria 3030
Country
Australia
Secondary sponsor category [1] 303619 0
None
Name [1] 303619 0
Address [1] 303619 0
Country [1] 303619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304074 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 304074 0
Ethics committee country [1] 304074 0
Australia
Date submitted for ethics approval [1] 304074 0
14/12/2018
Approval date [1] 304074 0
18/02/2019
Ethics approval number [1] 304074 0
2018-073

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

Contacts
Principal investigator
Name 95730 0
Ms Anne Harrison
Address 95730 0
Physiotherapy Department
Werribee Mercy Hospital
300 Princes Hwy
Werribee Victoria 3030
Country 95730 0
Australia
Phone 95730 0
+61 3 87543150
Fax 95730 0
Email 95730 0
AHarrison@mercy.com.au
Contact person for public queries
Name 95731 0
Anne Harrison
Address 95731 0
Physiotherapy Department
Werribee Mercy Hospital
300 Princes Hwy
Werribee Victoria 3030
Country 95731 0
Australia
Phone 95731 0
+61 03 87543150
Fax 95731 0
Email 95731 0
AHarrison@mercy.com.au
Contact person for scientific queries
Name 95732 0
Anne Harrison
Address 95732 0
Physiotherapy Department
Werribee Mercy Hospital
300 Princes Hwy
Werribee Victoria 3030
Country 95732 0
Australia
Phone 95732 0
+61 03 87543150
Fax 95732 0
Email 95732 0
AHarrison@mercy.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To ensure participant confidentiality and anonymity maintained


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.