Perceptions of Passive Heating in Individuals With T2DM

Sponsor
University of Portsmouth (Other)
Overall Status
Recruiting
CT.gov ID
NCT05016375
Collaborator
Portsmouth Hospitals NHS Trust (Other)
10
1
5
2

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interview

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

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
An Exploration of People's Perceptions of Undertaking Passive Heating as a Treatment for Type 2 Diabetes Mellitus
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
T2DM

Individuals with T2DM.

Other: Interview
Interview with individuals with T2DM

Outcome Measures

Primary Outcome Measures

  1. Explore bathing and spa behaviour by applying the social-ecological model to interpretivist thematic analysis. [~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.

Secondary Outcome Measures

  1. Explore perceived facilitators and barriers to passive heating by applying the social-ecological model to interpretivist thematic analysis. [~1 hour interview]

    To explore how participants perceive as the facilitators and barriers to engaging in passive heating within and outside the home.

  2. Explore how passive heating might impact physical activity by applying the social-ecological model to interpretivist thematic analysis. [~1 hour interview]

    To explore how engaging in passive heating might impact the physical activity of individuals with T2DM.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Sport and Exercise Science Portsmouth Hampshire United Kingdom PO1 2ER

Sponsors and Collaborators

  • University of Portsmouth
  • Portsmouth Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ant Shepherd, Senior lecturer, University of Portsmouth
ClinicalTrials.gov Identifier:
NCT05016375
Other Study ID Numbers:
  • 008AS
First Posted:
Aug 23, 2021
Last Update Posted:
Aug 23, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ant Shepherd, Senior lecturer, University of Portsmouth
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2021