NCT05016375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

July 20, 2021

Last Update Submit

April 20, 2023

Conditions

Keywords

Passive heating

Outcome Measures

Primary Outcomes (1)

  • 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.

    ~1 hour interview

Secondary Outcomes (2)

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

    ~1 hour interview

  • Explore how passive heating might impact physical activity by applying the social-ecological model to interpretivist thematic analysis.

    ~1 hour interview

Study Arms (1)

T2DM

Individuals with T2DM.

Other: Interview

Interventions

Interview with individuals with T2DM

T2DM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with T2DM

You may qualify if:

  • Aged 18 years or older
  • Willing and able to undertake the interview process
  • Able to give informed consent

You may not qualify if:

  • Age \< 18 years
  • Does not provide written informed consent
  • Any neurological/psychiatric diagnoses
  • Lack of fluency in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sport and Exercise Science

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

July 20, 2021

First Posted

August 23, 2021

Study Start

June 28, 2022

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations