Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/10/2020
Date assigned
04/11/2020
Last edited
30/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://dundee.onlinesurveys.ac.uk/kbpa-t1d

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

https://static.onlinesurveys.ac.uk/media/account/122/survey/652290/question/patient_information_sheet_v2_1.docx

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

http://www.dundee.ac.uk/

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

Publication citations

Additional files

Editorial Notes

30/10/2020: Trial’s existence confirmed by NHS HRA London - Harrow REC