Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000178347
Ethics application status
Approved
Date submitted
23/01/2017
Date registered
2/02/2017
Date last updated
6/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy and feasibility of a university-based high intensity interval training
program (Uni HIIT) on health and well-being in young adults
Scientific title
Evaluating the efficacy and feasibility of a university-based high intensity interval training
program (Uni HIIT) on health and well-being in young adults
Secondary ID [1] 290989 0
nil
Universal Trial Number (UTN)
Nil
Trial acronym
Uni HIIT
Linked study record
No link

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular health
 301749 0
Mental Health 301750 0
Condition category
Condition code
Mental Health 301447 301447 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 301448 301448 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
* Project summary:
The overarching aim of this study is to investigate the impact of a unique HIIT program (Uni
HIIT) on cardiorespiratory fitness (primary outcome), physical activity, body composition,
stress,executive function, well-being and psycho-social health outcomes in low active young adults when implemented in university settings. Using a randomised controlled trial (RCT) the Uni HIIT program will be implemented
Phase 1: single site RCT at the UoN (n=60)

The proposed study design is a randomised controlled trial with a wait-list control investigating the effects of an 8-week high intensity university-based interval training intervention.
Assessments will be conducted at baseline (March 2017) and repeated immediately
post-intervention (July 2017) and follow-up (November 2017) . Ethics approval for the study has been gained from the UoN Human Research Ethics Committee and study participants will provide written informed consent to take part in the study.
Uni HIIT Intervention Uni HIIT will be an 8-week intervention for university students focusing on improving fitness and psycho-social outcomes via the provision of short intense interval training sessions 3 times per week (total of 24 sessions). Sessions will be run by a member of the research team (qualified physical educators) and last 10 minutes in duration, with a work to rest ratio of 30 secs: 30 secs. Exercise will include a combination of 8 core aerobic exercises and 8 core strength exercises (e.g., running skipping, side stepping, push ups, squats, lunges); and combinations of these exercises using a ball (e.g. dribbling the ball while running, lunges holding a ball above the head). Baseline assessments will be completed one week prior to the intervention beginning, Follow-up assessments will be conducted in the week following intervention completion and 4-months.
Students will be randomised to either the:
i. High Intensity Interval Training plus body weight resistance training exercises (Uni HIIT )
conditions: which will combine cardio-based exercises and muscular fitness exercises; OR
ii. Wait-list Control group (CON): students randomised to CON will receive the HIIT Uni program once the intervention and all follow-up assessments have been completed by all groups.
To ensure appropriate exercise intensity is maintained throughout each session (target 85% HRMmax), participants will wear heart rate monitors (Polar H7) which connect to a central iPad application (Polar Team) monitored by a staff member. Minimum, maximum and average heart rate for the session will be recorded. Participants will have access to this information during sessions.
Based on the success of our previous HIITT study, and our studies investigating the effectiveness of variety in PA, program sessions will be designed to be enjoyable and include a variety of exercises to promote adherence. In addition, sessions will promote peer support and encouragement, and will be completed in pairs (participant choice); with one participant undertaking the ‘work’ phase while their partner rests (and vice-versa). As the intervention progresses participants will also be provided with additional elements of choice including: music(playlists), exercise choice during a workout, and choice of workout.
Note: Adherence to the program will be monitored via HR monitor data
Intervention code [1] 296946 0
Behaviour
Intervention code [2] 297016 0
Lifestyle
Intervention code [3] 297017 0
Treatment: Other
Comparator / control treatment
Wait-list Control group (CON): students randomised to CON will receive the HIIT Uni program once the intervention and all follow-up assessments have been completed by all groups (6months).
They will continue with their normal daily rountine during the intervention period
Control group
Active

Outcomes
Primary outcome [1] 300835 0
Cardiovascular Fitness (20 m shuttle run test)
Timepoint [1] 300835 0
Assessments will be conducted at baseline (March 2017) and repeated immediate post-intervention (week after intervention completion) (July 2017) and 4-month follow-up (November 2017) follow-up.
Secondary outcome [1] 330991 0
Muscular fitness (90 degree push-up test & the standing long jump)
Timepoint [1] 330991 0
Assessments will be conducted at baseline (March 2017) and repeated immediate post-intervention (week after intervention completion) (July 2017) and 4-month follow-up (November 2017) follow-up.
Secondary outcome [2] 330992 0
Body Composition (BMI BMI Z) and body fat distribution (DEXA / INBODY)
Timepoint [2] 330992 0
Assessments will be conducted at baseline (March 2017) and repeated immediately
post-intervention (July 2017) and 4 m0nth follow-up (November 2017) follow-up.
Secondary outcome [3] 330993 0
Psychological well-being
Global Physical Self-Concept (Physical Self-Description)
Psychological health: Strength and Difficulties Questionnaire (SDQ)
Exercise related wellbeing (Feelings Scale: The Flourishing Scale and The Scale of Positive and Negative Experience)
Psychological well-being: Diener psychological flourishing scale
Stress: Perceived Stress Scale
Anxiety: Spielberger State-Trait Anxiety Inventory (STAI) (short form)
Timepoint [3] 330993 0
Assessments will be conducted at baseline (March 2017) and repeated immediately
post-intervention (July 2017) and 4- month follow-up (November 2017) follow-up.
Secondary outcome [4] 330994 0
Executive function (The Trail Making Test (TMT) )
Timepoint [4] 330994 0
Assessments will be conducted at baseline (March 2017) and repeated immediately
post-intervention (July 2017) and 4 month follow-up (November 2017) follow-up.
Secondary outcome [5] 330995 0
Accelerometers will be used to assess physical activity across the week (Actigraph wrsit worn) instead of pedometer.
Timepoint [5] 330995 0
Assessments will be conducted at baseline (March 2017) and repeated immediately
post-intervention (July 2017) and 4-month follow-up (November 2017)
Secondary outcome [6] 330996 0
Motivation to engage in PA (Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2)
Timepoint [6] 330996 0
After each HIIT session

Eligibility
Key inclusion criteria
Male and female students from the UoN will be recruited to participate in the intervention and eligible study participants will be aged 18-25 years and have no existing medical conditions or injuries preventing participation is assessments or the Uni HIIT sessions
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Injury or illness preventing physical participation and / or age outside the 18-25 range

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)
Group allocation will be performed using a computer-based alogorithm performed by a researcher not involved in the study. Researchers performing assessments at baseline will also be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be performed using a computer-based alogorithm performed by a researcher not involved in the study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All outcomes will be assessed using linear mixed models in IBM SPSS Statistics for Windows (Version 20) (SPSS, INC 2010, IBM Company, Armonk, NY) and alpha levels set to 0.05. These models will be used to assess the impact of treatment (Uni HITT or control group), time (treated as categorical with levels that include baseline and follow-up) and group by time interaction.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/02/2017
Actual
21/02/2017
Date of last participant enrolment
Anticipated
14/03/2017
Actual
14/03/2017
Date of last data collection
Anticipated
15/12/2017
Actual
15/12/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295407 0
University
Name [1] 295407 0
The University of Newcastle
Country [1] 295407 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan NSW
Australia 2308
Country
Australia
Secondary sponsor category [1] 294229 0
None
Name [1] 294229 0
Address [1] 294229 0
Country [1] 294229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296740 0
University of Newcastle
Ethics committee address [1] 296740 0
University Drive Callaghan NSW 2308
Ethics committee country [1] 296740 0
Australia
Date submitted for ethics approval [1] 296740 0
01/12/2016
Approval date [1] 296740 0
08/12/2016
Ethics approval number [1] 296740 0
H-2016-0407

Summary
Brief summary
The overarching aim of this study is to investigate the impact of a unique HIIT program (Uni
HIIT) on cardiorespiratory fitness (primary outcome), physical activity, body composition,
stress,executive function, well-being and psycho-social health outcomes in low active young adults when implemented in university settings. Using a randomised controlled trial (RCT) the Uni HIIT program will be implemented
Phase 1: single site RCT at the UoN (n=60)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71934 0
Dr Narelle Eather
Address 71934 0
University of Newcastle
HPE310
University Drive
Callaghan, NSW 2308
Country 71934 0
Australia
Phone 71934 0
+61249216232
Fax 71934 0
Email 71934 0
[email protected]
Contact person for public queries
Name 71935 0
Dr Narelle Eather
Address 71935 0
University of Newcastle
HPE310
University Drive
Callaghan, NSW 2308
Country 71935 0
Australia
Phone 71935 0
+61249216232
Fax 71935 0
Email 71935 0
[email protected]
Contact person for scientific queries
Name 71936 0
Dr Narelle Eather
Address 71936 0
University of Newcastle
HPE310
University Drive
Callaghan, NSW 2308
Country 71936 0
Australia
Phone 71936 0
+61249216232
Fax 71936 0
Email 71936 0
[email protected]

No information has been provided regarding IPD availability


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.