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Completed

NCT Number: NCT05016375

Perceptions of Passive Heating in Individuals With T2DM

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Sport and Exercise Science

Portsmouth, Hampshire, PO1 2ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Interview with individuals with T2DM

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: ~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.

    Time frame: ~1 hour interview

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

Sponsors and collaborators

Lead sponsor

University of Portsmouth

Other

Collaborators

  • Portsmouth Hospitals NHS Trust

Registry information

Official study title

An Exploration of People's Perceptions of Undertaking Passive Heating as a Treatment for Type 2 Diabetes Mellitus

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2021
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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