Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001729213
Ethics application status
Approved
Date submitted
9/10/2018
Date registered
19/10/2018
Date last updated
19/11/2021
Date data sharing statement initially provided
8/08/2019
Date results provided
16/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can group education reduce fear of hypoglycaemia as a barrier to physical
activity in people living with type 1 diabetes?
Scientific title
Can self-management, group education reduce fear of hypoglycaemia as a barrier to physical
activity in people living with type 1 diabetes? A feasibility study.
Secondary ID [1] 295724 0
Nil known
Universal Trial Number (UTN)
U1111-1218-4469
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 309120 0
Condition category
Condition code
Metabolic and Endocrine 307996 307996 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The group, self-management workshop, ‘Type 1 TACTICS for Exercise’ will be the intervention under investigation. The intervention encourages group exploration of beliefs surrounding fear of hypoglycaemia as a barrier to Physical Activity (PA), before building knowledge using Dual Processing Theory and finally problem solving strategies to address this barrier. Throughout the three hour intervention, participants will be given the opportunity to explore the following topics throughout the intervention: pathophysiological effects of exercise in people with type 1 diabetes, barriers to PA, strategies to overcome barriers, insulin pharmacokinetics, specific strategies to manage Blood Glucose Levels (BGLs) during exercise, goal setting and general safety considerations. Grounded by the positive outcomes and behaviour change observed in the DESMOND program (Davies et al., 2008), the facilitator will draw on Social Learning Theory (Bandura, 1977) and to a lesser extent, Dual Processing Theory (Chaiken, Wood, & Eagly, 1996) and Leventhal’s Common Sense Model (Dieffenbach & Leventhal, 1996) to deliver the program content.

A ‘booster’ one-hour workshop (intervention - part II) will be held four weeks following intervention part I. The intervention arm will also have access to an ongoing, private social media page for those who have completed the intervention – part I. A private social media page will be offered to graduates of part I of the intervention to allow ongoing peer discussion and problem solving as participants try new strategies to manage BGLs for PA, while networking with like-minded individuals. The interventions will be held in areas north and south of Perth metropolitan area, Western Australia.

Intervention – part I. The group, self-management workshop, ‘Type 1 TACTICS for Exercise’ will be the intervention under investigation. Groups of 10 participants will meet face to face in a group setting for part I and part II of the intervention and control arms. The intervention encourages group exploration and discussion of beliefs surrounding FoH as a barrier to PA, before building knowledge using Dual Processing Theory and finally problem solving strategies to address this barrier. Participants will be given the opportunity to explore the following topics throughout the intervention: pathophysiological effects of exercise in people with T1D, barriers to physical activity, strategies to overcome barriers, insulin pharmacokinetics, specific strategies to manage BGLs during exercise, goal setting and general safety considerations. Intervention content relating to current evidence based strategies to manage BGLs for PA was based on the consensus statement by Riddell et al. (2017). Grounded by the positive outcomes and behaviour change observed in the DESMOND program (Davies et al., 2008), the facilitator will draw on Social Learning Theory (Bandura, 1977) and to a lesser extent, Dual Processing Theory (Chaiken, Wood, & Eagly, 1996) and Leventhal’s Common Sense Model (Diefenbach & Leventhal, 1996) to deliver the program content. The workshop will be run over a three-hour period by a facilitator (the PhD candidate) who is an Accredited Exercise Physiologist, Credentialed Diabetes Educator and Accredited DESMOND facilitator, with extensive knowledge and qualifications in the area of diabetes and exercise.

The private social media page will be offered to graduates of part I of the intervention to allow ongoing peer discussion and problem solving as participants try new strategies to manage BGLs for PA, while networking with like-minded individuals. Participants will have the opportunity to post their questions and experiences as well as comment and contribute to other forum conversations. Participation in the social media page will be voluntary. The page will be administered and mediated by the intervention facilitator and monitored at least once per day during the intervention phase. The facilitator will be available to help direct conversation, ensure safe advice is being offered and to ensure appropriate etiquette is being followed by all group members. All participants will be given the facilitator’s email contact details should they prefer this mode of contact. Social media utilisation and frequency will be measured using a questionnaire item as well as by collecting social media platform data. Qualitative focus groups will also explore participant’s experience of this aspect of the intervention.

Intervention – part II. Participants will be asked to attend a one hour follow up ‘booster’ session (intervention – part II) four weeks following intervention – part I which will be facilitated by the same educator from part 1. Participants will be asked to return for the booster session with an example of their experience using different strategies to manage BGLs for PA. An icebreaker activity relating to common themes found on the social media page will also be used to initiate discussion. Participants will problem solve as a group using the ‘timeline’ activity used in intervention - part I. Bandura’s Social Learning Theory suggests individual’s change in self-efficacy are derived from four sources: performance accomplishments, vicarious experience, verbal persuasion and physiological states (Bandura, 1977). The booster session will allow for greater exploration of these four sources after participants have had the opportunity to go away and experience and master new skills. Ongoing exploration of these experiences with their peers in the booster session and via social media will further consolidate self-efficacy.

In an effort to standardise the delivery and limit variability of the intervention and control, clear program aims and objectives exist along with a facilitator manual outlining key content and messages to be covered in each section. To further improve fidelity, all interventions and control groups will be facilitated by the same person. With permission of participants, video of three intervention and three control workshops (Part I and II) will be recorded to enable assessment of facilitator behaviours. Observed facilitator behaviour will be assessed using specifically designed assessment tools and facilitator talk time as recommended by Skinner et al. (2008). Intervention and control group content will also be examined using these video recordings to ensure key messages (as set out in the program manual) are consistently being covered. Assessment will be conducted by an independent experienced program assessor from Diabetes WA.


Intervention code [1] 302048 0
Behaviour
Comparator / control treatment
The control arm/standard care arm will involve a one hour group information session where the facilitator will disseminate standard PA guidelines and safety considerations including how to recognise and treat hypoglycaemia. This will be followed by a further one hour information session – part II, four weeks following part I and will involve a review of recognising and treating hypoglycaemia as a result of PA and discussion around existing services available in the community.

Control groups will be held north and south of Perth metropolitan area. The same facilitator will be used to facilitate both the intervention and control group arms.
Control group
Active

Outcomes
Primary outcome [1] 306976 0
Change to the strength of fear of hypoglycaemia as a barrier to PA will be the primary outcome of the study. This will be measured using the validated Barriers to Physical Activity in Diabetes - Type 1 (BAPAD1) scale.
Timepoint [1] 306976 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II
Primary outcome [2] 307788 0
Feasibility and acceptability of the study design and intervention.
Timepoint [2] 307788 0
Questionnaire completion or attrition rates will indicate whether this study design (including willingness to be randomised) is acceptable to participants. Incomplete questionnaires will also determine feasibility of data collection methods. Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II Multiple focus groups held for both the control and intervention arms will further inform quantitative results as well as detail any issue with study and intervention design. Focus groups will be held upon completion of all quantitive data collection (approximately 14 weeks following intervention/control part I)
Secondary outcome [1] 350298 0
Changes to intention to participate in PA using investigator developed Likert scales.
Timepoint [1] 350298 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II
Secondary outcome [2] 350299 0
Changes to self-reported participation in PA using the validated International Physical Activity Questionnaire - Short form
Timepoint [2] 350299 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II
Secondary outcome [3] 350300 0
Changes in self-reported episodes of hypoglycaemia using a investigator developed item
Timepoint [3] 350300 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II
Secondary outcome [4] 350301 0
Changes in self-efficacy in managing blood glucose levels for PA using an investigator developed item - Likert scale
Timepoint [4] 350301 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II
Secondary outcome [5] 350302 0
Changes to diabetes distress using the validated Problem Areas In Diabetes - Short form scale.
Timepoint [5] 350302 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II
Secondary outcome [6] 350303 0
Changes to well-being measured by the validated WHO-5 Well-being Index.
Timepoint [6] 350303 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II
Secondary outcome [7] 352890 0
Changes to attitudes towards PA using investigator developed Likert scales.
Timepoint [7] 352890 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II
Secondary outcome [8] 352891 0
Changes to self-efficacy towards PA using investigator developed Likert scales.
Timepoint [8] 352891 0
Questionnaire will be administered; Immediately before intervention/control part I Immediately before intervention/control part II (4 weeks after part I) 8 weeks post intervention/control part II

Eligibility
Key inclusion criteria
Included participants will be those with type 1 diabetes, diagnosed for at least 6 months, aged between 18 to 65 years, living in Perth, Western Australia and who are proficient in English.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who have significant macro or microvascular diabetes complications or who are not within the age range will be excluded from the research. Those who took part in the previous explorative study conducted by Diabetes WA and Curtin University in 2017 will also be excluded from this study.

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)
Central randomisation by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation matrix.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary aim of this study is to determine feasibility, acceptability and preliminary efficacy of the intervention and study design. Although this study will not be powered, it will inform future powered randomised control trials.

Participant characteristics and responses will be summarised and compared using the mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Inferential statistics will be used to analyse within and between group comparisons. Data from each scale will be treated as recommended by relevant validation literature for each respective tool.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2019
Actual
25/02/2019
Date of last participant enrolment
Anticipated
9/09/2019
Actual
9/09/2019
Date of last data collection
Anticipated
31/12/2019
Actual
28/12/2019
Sample size
Target
120
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11568 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 11569 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 11570 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 11571 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [5] 11572 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 23612 0
6150 - Murdoch
Recruitment postcode(s) [2] 23613 0
6009 - Nedlands
Recruitment postcode(s) [3] 23614 0
6000 - Perth
Recruitment postcode(s) [4] 23615 0
6168 - Cooloongup
Recruitment postcode(s) [5] 23616 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 300315 0
University
Name [1] 300315 0
Curtin University
Country [1] 300315 0
Australia
Funding source category [2] 307406 0
Charities/Societies/Foundations
Name [2] 307406 0
Australian Diabetes Research Foundation
Country [2] 307406 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 299750 0
None
Name [1] 299750 0
Address [1] 299750 0
Country [1] 299750 0
Other collaborator category [1] 280280 0
Charities/Societies/Foundations
Name [1] 280280 0
Diabetes WA
Address [1] 280280 0
3/322 Hay Street, Subiaco WA 6008
Country [1] 280280 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301126 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 301126 0
Ethics committee country [1] 301126 0
Australia
Date submitted for ethics approval [1] 301126 0
31/10/2018
Approval date [1] 301126 0
14/12/2018
Ethics approval number [1] 301126 0
HRE2018-0795

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2937 2937 0 0
/AnzctrAttachments/375722-Appendix 3 - Study Design Feasibility study.pdf

Contacts
Principal investigator
Name 85946 0
Dr Janie Brown
Address 85946 0
Curtin University School of Nursing, Midwifery and Paramedicine Faculty of Health Sciences Kent Street, Bentley WA 6102
Country 85946 0
Australia
Phone 85946 0
+61 8 9266 2213
Fax 85946 0
Email 85946 0
[email protected]
Contact person for public queries
Name 85947 0
Marian Brennan
Address 85947 0
Diabetes WA 3/322 Hay Street, Subiaco WA 6008
Country 85947 0
Australia
Phone 85947 0
+61 8 9436 6220
Fax 85947 0
Email 85947 0
[email protected]
Contact person for scientific queries
Name 85948 0
Marian Brennan
Address 85948 0
Diabetes WA 3/322 Hay Street, Subiaco WA 6008
Country 85948 0
Australia
Phone 85948 0
+61 8 9436 6220
Fax 85948 0
Email 85948 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Confidentiality



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Study-related document.pdf


Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.