Knowledge and barriers related to physical activity in type 1 diabetes
| ISRCTN | ISRCTN18126852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18126852 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 280818 |
| Protocol serial number | IRAS 280818 |
| Sponsor | University of Dundee |
| Funder | Investigator initiated and funded |
- Submission date
- 17/10/2020
- Registration date
- 04/11/2020
- Last edited
- 12/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Public
Clincal Research Centre Tayside
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0002-0785-467X |
|---|---|
| Phone | +44 (0)1382 388573 |
| a.stjohn@dundee.ac.uk |
Scientific
Clincal Research Centre Tayside
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 388573 |
|---|---|
| A.D.McNeilly@dundee.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional survey |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Assessing disease management knowledge and barriers related to physical activity in type 1 diabetes via online questionnaire. |
| Study acronym | KBPA T1D |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Measured using a 61 item questionnaire at a single time point: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 01/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Person with type 1 diabetes 2. Aged 18 or over 3. Able to read and write in English |
| Key exclusion criteria | 1. Participant is unable to complete the survey. |
| Date of first enrolment | 21/10/2020 |
| Date of final enrolment | 01/01/2021 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Dundee
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2 | 10/07/2020 | 12/01/2023 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN18126852_PROTOCOL_V2_10Jul20.pdf
- Protocol file
Editorial Notes
12/01/2023: Protocol file uploaded (not peer reviewed).
30/10/2020: Trial’s existence confirmed by NHS HRA London - Harrow REC
