Type 2 DiabetesNCT05016375
Perceptions of Passive Heating in Individuals With T2DM
An observational study of Type 2 Diabetes, run by University of Portsmouth at 1 site in United Kingdom.
Trial summary
Current treatments for type 2 diabetes (e.g., lifestyle changes and clinical interventions such as medication), have been shown to be unsustainable due to low levels of physical activity and increasing clinical costs. Therefore, scientists have been looking for new treatments to address this issue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Interview
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2022to 21 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with T2DM
Who may be able to join
- Aged 18 years or older
- Willing and able to undertake the interview process
- Able to give informed consent
Who cannot join
- Age < 18 years
- Does not provide written informed consent
- Any neurological/psychiatric diagnoses
- Lack of fluency in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Sport and Exercise Science
Portsmouth, Hampshire, PO1 2ER
About this study
Official title: An Exploration of People's Perceptions of Undertaking Passive Heating as a Treatment for Type 2 Diabetes Mellitus
Current treatments for type 2 diabetes (e.g., lifestyle changes and clinical interventions such as medication), have been shown to be unsustainable due to low levels of physical activity and increasing clinical costs. Therefore, scientists have been looking for new treatments to address this issue. One such treatment that is being investigated is passive heating (e.g., hot baths, saunas, etc.). In this study the investigators want to ascertain what passive heating, if any, individuals with T2DM currently do, what their perceptions of passive heating would be if it were to become a treatment, what may make it easier or more difficult for them to engage in passive heating, and how this might impact other areas of their life such as physical activity.
Read the detailed description
This study employs an interpretivist approach through semi-structured interviews to highlight participants' perceptions of and experiences with passive heating. To date, this topic has not been explored in-depth - this approach should bring nuance and context to light, aiding in future advocacy work which explores the potential of passive heating as a viable treatment for adults with T2DM.
Semi-structured interviews will be facilitated by an interview guide consisting of four main topic areas aiming to explore an individual's perception of and experience with passive heating as a treatment for T2DM and to ascertain whether engaging in this behaviour may affect physical activity. As no two conversations are ever the same, the approach to the interviews is one of flexibility through the use of open-ended questions and potential probes as the situation dictates - remaining open to following particular lines of participant thought.
Interviews will all be conducted by the Principal investigator, Mr Thomas James, a doctoral researcher who has been trained in the required skills. He has also undertaken necessary training in Good Clinical Practice and Valid Informed Consent. Interviews will be conducted virtually, by telephone or in person and will take place either at home or in a laboratory setting, dependent upon the individual's wishes. The interviews will be audio recorded and subsequently transcribed verbatim by a member of the research team. Transcriptions will be analysed via thematic analysis to determine the main themes expressed by participants. All data analysis will be conducted by a trained member of the research team.
- Conditions
- Type 2 Diabetes
- Being tested
- Interview
- Keywords
- Passive heating
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interview with individuals with T2DM
| Study group | Role | What they receive |
|---|---|---|
| T2DM | Individuals with T2DM. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore bathing and spa behaviour by applying the social-ecological model to interpretivist thematic analysis.
To explore the current bathing and spa behaviours among individuals living with T2DM and their perceptions regarding passive heating as a treatment.
Measured: ~1 hour interview
Secondary outcomes (2)
Explore perceived facilitators and barriers to passive heating by applying the social-ecological model to interpretivist thematic analysis.
To explore how participants perceive as the facilitators and barriers to engaging in passive heating within and outside the home.
Measured: ~1 hour interview
Explore how passive heating might impact physical activity by applying the social-ecological model to interpretivist thematic analysis.
To explore how engaging in passive heating might impact the physical activity of individuals with T2DM.
Measured: ~1 hour interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start28 Jun 2022
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Responsible party
- Principal investigator, Ant Shepherd, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016375
- Sponsor's protocol ID
- 008AS
- Status last verified
- Apr 2023
- First submitted
- 20 Jul 2021
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of People's Perceptions of Undertaking Passive Heating as a Treatment for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05016375
- Acronym / sponsor ID
- 008AS
- Conditions
- Type 2 Diabetes
- Keywords
- Passive heating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current treatments for type 2 diabetes (e.g., lifestyle changes and clinical interventions such as medication), have been shown to be unsustainable due to low levels of physical activity and increasing clinical costs. Therefore, scientists have been looking for new treatments to address this issue. One such treatment that is being investigated is passive heating (e.g., hot baths, saunas, etc.). In this study the investigators want to ascertain what passive heating, if any, individuals with T2DM currently do, what their perceptions of passive heating would be if it were to become a treatment, what may make it easier or more difficult for them to engage in passive heating, and how this might impact other areas of their life such as physical activity.
Detailed description
This study employs an interpretivist approach through semi-structured interviews to highlight participants' perceptions of and experiences with passive heating. To date, this topic has not been explored in-depth - this approach should bring nuance and context to light, aiding in future advocacy work which explores the potential of passive heating as a viable treatment for adults with T2DM.
Semi-structured interviews will be facilitated by an interview guide consisting of four main topic areas aiming to explore an individual's perception of and experience with passive heating as a treatment for T2DM and to ascertain whether engaging in this behaviour may affect physical activity. As no two conversations are ever the same, the approach to the interviews is one of flexibility through the use of open-ended questions and potential probes as the situation dictates - remaining open to following particular lines of participant thought.
Interviews will all be conducted by the Principal investigator, Mr Thomas James, a doctoral researcher who has been trained in the required skills. He has also undertaken necessary training in Good Clinical Practice and Valid Informed Consent. Interviews will be conducted virtually, by telephone or in person and will take place either at home or in a laboratory setting, dependent upon the individual's wishes. The interviews will be audio recorded and subsequently transcribed verbatim by a member of the research team. Transcriptions will be analysed via thematic analysis to determine the main themes expressed by participants. All data analysis will be conducted by a trained member of the research team.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2DM | – | Other: InterviewIndividuals with T2DM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with T2DM
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Willing and able to undertake the interview process
- Able to give informed consent
Key exclusion criteria (4 listed)
- Age < 18 years
- Does not provide written informed consent
- Any neurological/psychiatric diagnoses
- Lack of fluency in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewInterview with individuals with T2DM | Other | T2DM |
Primary outcome
Explore bathing and spa behaviour by applying the social-ecological model to interpretivist thematic analysis.
Time frame: ~1 hour interview
To explore the current bathing and spa behaviours among individuals living with T2DM and their perceptions regarding passive heating as a treatment.
2 secondary outcomes
Explore perceived facilitators and barriers to passive heating by applying the social-ecological model to interpretivist thematic analysis.
Time frame: ~1 hour interview
Explore how passive heating might impact physical activity by applying the social-ecological model to interpretivist thematic analysis.
Time frame: ~1 hour interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Portsmouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore bathing and spa behaviour by applying the social-ecological model to interpretivist thematic analysis. (time frame: ~1 hour interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.