Plain English Summary
Background and study aims
Type 1 diabetes causes the level of glucose (sugar) in the blood to become too high. It happens when the body cannot produce enough of a hormone called insulin, which controls blood glucose.
There are many clear health benefits from regular physical activity; including reduced risks for heart disease, loss of bone strength, obesity, lower back pain, and depression.
Recent publications have shown that in general, people with type 1 diabetes participate in less regular physical activity than non-diabetic populations.
Barriers to physical activity have been shown to reduce physical activity levels, thus it is important to identify the most restrictive and most common barriers experienced by those with type 1 diabetes.
We want to find out the most significant barriers to physical activity, and why they exist. This survey will ask participants about any personal barriers they may have, physical activity habits, and overall knowledge regarding physical activity and type 1 diabetes.
Who can participate?
Those aged 18 or over that are able to read and write in English and have been diagnosed with type 1 diabetes.
What does the study involve?
The study involves the completion of a 61-question anonymous survey that will take about 5-10 minutes to complete.
What are the possible benefits and risks of participating?
None.
Where is the study run from?
Clinical Research Centre Tayside, Ninewells Hospital & Medical School (UK)
When is the study starting and how long is it expected to run for?
September 2019 to January 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Alex St. John,
a.stjohn@dundee.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Alex St. John
ORCID ID
http://orcid.org/0000-0002-0785-467X
Contact details
Clincal Research Centre Tayside
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 388573
a.stjohn@dundee.ac.uk
Type
Scientific
Additional contact
Dr Alison McNeilly
ORCID ID
Contact details
Clincal Research Centre Tayside
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 388573
A.D.McNeilly@dundee.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 280818
Study information
Scientific title
Assessing disease management knowledge and barriers related to physical activity in type 1 diabetes via online questionnaire.
Acronym
KBPA T1D
Study hypothesis
1. What are the most prevalent barriers to physical activity in people with type 1 diabetes?
2. What are the most common health benefits seen in type 1 diabetes as a result of physical activity?
3. What are the best ways for healthcare practitioners to discuss physical activity with people with type 1 diabetes?
4. What are the best recommendations for sport participation for people with type 1 diabetes?
5. What impacts do socioeconomic status have on physical activity and type 1 diabetes?
Ethics approval
Approved 09/10/2020 London - Harrow REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8057; harrow.rec@hra.nhs.uk), ref: 20/PR/0081
Study design
Observational cross-sectional survey
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Internet
Trial type
Quality of life
Patient information sheet
Condition
Identification of the most prevalent barriers to physical activity in patients with type 1 diabetes
Intervention
The link to the online survey (https://dundee.onlinesurveys.ac.uk/kbpa-t1d) will be shared on various social media outlets (Twitter, Facebook, Instagram). Upon arriving at the above link, the participant will be directed towards downloading/reading the Patient Information Sheet (PIS) within the first page of the online survey. The following page will act as an acknowledgement of the PIS and the participant’s opportunity to ask the research team any questions. The third page of the survey includes definitions of terms within the survey that some participants may not know. Pages 4-10 include the survey body, with the 11th page being a “thank you” message. The total duration of the online survey will be no longer than 10 minutes, with a majority of participants thus far taking 5-6 minutes to complete it. There will be no follow-up within this study.
The survey consists of five main sections as well as an introductory ‘Definitions’ section.
The ‘Definitions’ section will outline specific terms and phrases used within the survey with which some participants may be unfamiliar.
Section 1, ‘Demographics’ will ask participants their age range, gender, location, length of T1D diagnosis, and most recent HbA1c.
Section 2, ‘Physical Activity Barriers’ will ask participants to indicate how likely an item would keep them from participating in PA during the next six months. Items will include potential barriers to PA.
Section 3, ‘Diabetes Management’ will ask participants about their current treatment of their T1D, the information they discuss in clinic visits and their knowledge on PA information resources and condition management around PA.
Section 4, ‘Exercise’ will ask participants about their participation frequency of various forms of exercise, as well as changes from euglycemia around exercise.
Section 5, ‘Sport’ will ask participants about their participation frequency of sport, as well as changes from euglycemia around sport. It will also ask participants to indicate the degree to which they agree with statements pertaining to PA enjoyment, and the effects of their condition on their sport participation.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Measured using a 61 item questionnaire at a single time point:
1. Demographics: age range, gender, location, length of T1D diagnosis, and most recent HbA1c
2. Physical Activity Barriers: participants indicate how likely an item would keep them from participating in PA during the next six months. Items will include potential barriers to PA
3. Diabetes Management: current treatment of T1D, the information they discuss in clinic visits and their knowledge on PA information resources and condition management around PA
4. Exercise: participation frequency of various forms of exercise, as well as changes from euglycemia around exercise
5. Sport: participation frequency of sport, as well as changes from euglycemia around sport. Participants indicate the degree to which they agree with statements pertaining to PA enjoyment, and the effects of their condition on their sport participation
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
03/09/2019
Overall trial end date
01/01/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Person with type 1 diabetes
2. Aged 18 or over
3. Able to read and write in English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Participant is unable to complete the survey.
Recruitment start date
21/10/2020
Recruitment end date
01/01/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Research Centre Tayside
Ninewells Hospital & Medical School, Residency Block, Level 3, George Pirie Way
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee
Sponsor details
Ninewells Hospital & Medical School
TASC Research and Development Office
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383945
TASCgovernance@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
30/12/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list