- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05016375
Perceptions of Passive Heating in Individuals With T2DM
An Exploration of People's Perceptions of Undertaking Passive Heating as a Treatment for Type 2 Diabetes Mellitus
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hampshire
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Portsmouth, Hampshire, United Kingdom, PO1 2ER
- Department of Sport and Exercise Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 years or older
- Willing and able to undertake the interview process
- Able to give informed consent
Exclusion Criteria:
- Age < 18 years
- Does not provide written informed consent
- Any neurological/psychiatric diagnoses
- Lack of fluency in English
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
T2DM
Individuals with T2DM.
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Interview with individuals with T2DM
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Explore bathing and spa behaviour by applying the social-ecological model to interpretivist thematic analysis.
Time Frame: ~1 hour interview
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To explore the current bathing and spa behaviours among individuals living with T2DM and their perceptions regarding passive heating as a treatment.
|
~1 hour interview
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explore perceived facilitators and barriers to passive heating by applying the social-ecological model to interpretivist thematic analysis.
Time Frame: ~1 hour interview
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To explore how participants perceive as the facilitators and barriers to engaging in passive heating within and outside the home.
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~1 hour interview
|
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Explore how passive heating might impact physical activity by applying the social-ecological model to interpretivist thematic analysis.
Time Frame: ~1 hour interview
|
To explore how engaging in passive heating might impact the physical activity of individuals with T2DM.
|
~1 hour interview
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 008AS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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