Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001077156
Ethics application status
Approved
Date submitted
22/07/2019
Date registered
5/08/2019
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Short-term temperature changes and physiological performance
Scientific title
Short-term ambient temperature changes and physiological performance in healthy volunteers.
Secondary ID [1] 298798 0
None
Universal Trial Number (UTN)
U1111-1234-7550
Trial acronym
TAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 313751 0
Condition category
Condition code
Diet and Nutrition 312154 312154 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be exposed to different ambient temperature conditions and their physiological performance monitored. The three different conditions are:
-Cold (13 degrees)
-Normal (23 degrees)
-Warm (33 degrees)

Participants will enter the environmental simulation suite and spend 2 hours exposed to each condition. The exposures will occur on separate days with a minimum 24-hour washout period between experimental conditions. During that time, their cognitive performance will be assessed using a computer-based test. Their resting energy expenditure will be assessed using indirect calorimetry with a hood.

Participants will then be provided with a selection of food choices to eat during the final 60 minutes inside the simulation suite. The energy and food choices will be recorded and compared between conditions. All measures will be made by a University research student working towards a PhD.
Intervention code [1] 315067 0
Lifestyle
Comparator / control treatment
A normal temperature (thermoneutral range) will serve as the control condition. Each participant will undergo testing in each condition and serve as their own control.
Control group
Active

Outcomes
Primary outcome [1] 320798 0
Net calorie intake consumed by the participant during the intervention.

Timepoint [1] 320798 0
At end of two hour interventional exposure
Primary outcome [2] 320799 0
Resting energy expenditure as assessed by indirect calorimetry using a hood.
Timepoint [2] 320799 0
30 minutes resting energy expenditure assessment under each intervention.
Secondary outcome [1] 372894 0
Productivity performance as assessed by custom-written testing software using PEBL2.
Timepoint [1] 372894 0
30 minute cognitive test under each experimental condition

Eligibility
Key inclusion criteria
Inclusion criteria
• Healthy individuals (age 18-50 years)
• Stable weight and diet for the previous three months
• Body mass index <30 kg/m2
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
• Pregnancy
• Previous radiographic scan in last 3 months
• Body mass index >30 kg/m2

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of experimental conditions for each participant will be decided by a computer-generated random number allocation system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculations were based on the data provided by Richardson et al. who demonstrated a large effect size for our primary outcome. A sample size of 19 participants could achieve 80% power to detect a 0.7 SD of paired differences with a significance level of 0.05 using a two-sided paired t-test. Based on previous work on this nature, we anticipate low drop out and therefore propose total participant recruitment of 20. Calculations were performed using G*Power statistical software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/07/2019
Date of last participant enrolment
Anticipated
20/12/2019
Actual
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 21705 0
New Zealand
State/province [1] 21705 0
Wellington

Funding & Sponsors
Funding source category [1] 303356 0
Charities/Societies/Foundations
Name [1] 303356 0
Wellington Medical Research Foundation
Country [1] 303356 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
23a Mein Street
Newtown
Wellington
New Zealand 6021
Country
New Zealand
Secondary sponsor category [1] 303391 0
None
Name [1] 303391 0
Address [1] 303391 0
Country [1] 303391 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303886 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 303886 0
Ethics committee country [1] 303886 0
New Zealand
Date submitted for ethics approval [1] 303886 0
Approval date [1] 303886 0
25/06/2019
Ethics approval number [1] 303886 0
19/NTA/83

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95126 0
Mr Terry O'Donnell
Address 95126 0
University of Otago Wellington
23a Mein Street
Newtown 6021
Wellington
Country 95126 0
New Zealand
Phone 95126 0
+64 8061504
Fax 95126 0
Email 95126 0
[email protected]
Contact person for public queries
Name 95127 0
Terry O'Donnell
Address 95127 0
University of Otago Wellington
23a Mein Street
Newtown 6021
Wellington
Country 95127 0
New Zealand
Phone 95127 0
+64 8061504
Fax 95127 0
Email 95127 0
[email protected]
Contact person for scientific queries
Name 95128 0
Terry O'Donnell
Address 95128 0
University of Otago Wellington
23a Mein Street
Newtown 6021
Wellington
Country 95128 0
New Zealand
Phone 95128 0
+64 8061504
Fax 95128 0
Email 95128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will be kept private due to health data privacy concerns. Aggregated data will be available to any parties who contact the study coordinating investigator.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.