Knowledge and barriers related to physical activity in type 1 diabetes

ISRCTN ISRCTN18126852
DOI https://doi.org/10.1186/ISRCTN18126852
IRAS number 280818
Secondary identifying numbers IRAS 280818
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Study website

Contact information

Mr Alex St. John
Public

Clincal Research Centre Tayside
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

ORCiD logoORCID ID 0000-0002-0785-467X
Phone +44 (0)1382 388573
Email a.stjohn@dundee.ac.uk
Dr Alison McNeilly
Scientific

Clincal Research Centre Tayside
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Phone +44 (0)1382 388573
Email A.D.McNeilly@dundee.ac.uk

Study information

Study designObservational cross-sectional survey
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Internet/virtual
Study typeQuality of life
Participant information sheet https://static.onlinesurveys.ac.uk/media/account/122/survey/652290/question/patient_information_sheet_v2_1.docx
Scientific titleAssessing disease management knowledge and barriers related to physical activity in type 1 diabetes via online questionnaire.
Study acronymKBPA T1D
Study objectives1. 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) studiedIdentification of the most prevalent barriers to physical activity in patients with type 1 diabetes
InterventionThe 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 typeOther
Primary outcome measureMeasured 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 measuresThere are no secondary outcome measures
Overall study start date03/09/2019
Completion date01/01/2021

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. Person with type 1 diabetes
2. Aged 18 or over
3. Able to read and write in English
Key exclusion criteria1. Participant is unable to complete the survey.
Date of first enrolment21/10/2020
Date of final enrolment01/01/2021

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Clinical Research Centre Tayside
Ninewells Hospital & Medical School, Residency Block, Level 3, George Pirie Way
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee
University/education

Ninewells Hospital & Medical School
TASC Research and Development Office
George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom

Phone +44 (0)1382 383945
Email TASCgovernance@dundee.ac.uk
Website http://www.dundee.ac.uk/
ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/12/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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?
Protocol file version 2 10/07/2020 12/01/2023 No No
HRA research summary 26/07/2023 No No

Additional files

ISRCTN18126852_PROTOCOL_V2_10Jul20.pdf

Editorial Notes

12/01/2023: Protocol file uploaded (not peer reviewed).
30/10/2020: Trial’s existence confirmed by NHS HRA London - Harrow REC