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Trial registered on ANZCTR


Registration number
ACTRN12619000951156
Ethics application status
Approved
Date submitted
23/06/2019
Date registered
8/07/2019
Date last updated
17/03/2021
Date data sharing statement initially provided
8/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise format and social environment during 12-week training on post-exercise food intake
Scientific title
The effect of exercise format and social environment during 12-week training on post-exercise food intake in inactive volunteers
Secondary ID [1] 298251 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 312849 0
Metabolic disease 312850 0
Condition category
Condition code
Diet and Nutrition 311351 311351 0 0
Obesity
Metabolic and Endocrine 311963 311963 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ a between-subjects yoked design whereby participants will be pair-matched on variables measured at an initial familiarisation session, including sex, fitness, body mass, and height. Within each pair, each participant will be randomised, using a random number generator, to one of two 12-week training interventions, commencing one week following the pre-intervention assessment. The training intervention will involve three sessions per week on a stationary cycle ergometer, supervised by an exercise scientist. To accommodate for an increase in fitness throughout the intervention period, the workload and duration of training sessions will be progressively increased (e.g., 30 min during weeks 1-3, 35 mins during weeks 4-6, etc.). Participants randomised to the interval training group will be required to complete repeated bouts of high-intensity cycling (15 s at a power output equivalent to ~170% VO2peak) with an active recovery period (60 s at a power output of ~32% VO2peak) between efforts. Verbal psychological need-support will be provided to participants in this intervention through a number of well-established techniques, at the researchers' discretion. For example, autonomy-support will be facilitated by providing clear rationales and the benefits of the exercise, offering choices where possible, and using non-controlling language. Competence will be supported by providing clear instructions and expectations, offering positive feedback, and encouraging goal setting. Relatedness will be provided by interacting with warmth and care, offering empathy where appropriate, and displaying appreciation and concern for participants’ well-being. To confirm that the desired psychological conditions have been established, participants will complete a validated questionnaire to assess instructor psychological need-support (see secondary outcomes).
Intervention code [1] 314494 0
Behaviour
Comparator / control treatment
Participants allocated to the moderate-intensity continuous exercise (standard-care) condition will cycle at a continuous power output equivalent to 60% peak oxygen consumption (VO2peak) for 30 minutes, in line with current global recommendations. To facilitate a neutral social environment, participants in this condition will receive ‘typical’ exercise instructions (i.e., autonomy, competence, and relatedness will not be supported and no attempts will be made to purposely undermine participants’ experiences. Total work and mean power will be matched between the exercise conditions. To confirm that the desired 'neutral' psychological conditions have been established, participants will complete a validated questionnaire to assess instructor psychological need-support (see secondary outcomes).
Control group
Active

Outcomes
Primary outcome [1] 320080 0
Post-exercise energy intake will be assessed via a buffet-style laboratory test meal provided 20 minutes post completion of exercise. Food products will consist of known and differing macronutrient composition, including an assortment of typical breakfast foods and treats such as bread, spreads, cereal, milk, fruit, muffins, and biscuits. All food provided will be weighed before participants’ arrival and re-weighed after consumption. In addition to energy intake at the immediate post-exercise meal, food intake will also be measured in the laboratory during the subsequent hours (three-hours total), during which participants will have free-access to a number of typical snack items (e.g., fruit, chocolate, salted chips/crisps).
Timepoint [1] 320080 0
One week pre- and one week post-intervention.
Secondary outcome [1] 370460 0
Body composition will be assessed using a dual-energy X-ray absorpiometry machine (Lunar iDXA, GE Healthcare, Madison WI, USA). Scanned images will be analysed for body fat mass.
Timepoint [1] 370460 0
One week pre- and one week post-intervention.
Secondary outcome [2] 370461 0
Peak oxygen consumption (VO2peak) will be measured using a continuous graded exercise test on a calibrated front-access cycle ergometer.
Timepoint [2] 370461 0
One week pre- and immediately post-intervention.
Secondary outcome [3] 370463 0
Capillary blood lactate, obtained from the fingertip using a sterile lancet, will be assessed immediately pre- and post-exercise during pre- and post-intervention assessments.
Timepoint [3] 370463 0
One week pre- and immediately post-intervention.
Secondary outcome [4] 370464 0
Capillary blood glucose, obtained from the fingertip using a sterile lancet, will be assessed immediately pre- and post-exercise during pre- and post-intervention assessments.
Timepoint [4] 370464 0
One week pre- and immediately post-intervention.
Secondary outcome [5] 370465 0
Free-living energy intake will be assessed using a four-day food diary pre- and post-intervention. Mean total energy intake will be determined using a commercially available software program (Foodworks; Xyris Software, Queensland, Australia).
Timepoint [5] 370465 0
Pre- (week prior) and post (week after) the intervention
Secondary outcome [6] 370466 0
Free-living physical activity will be assessed via accelerometry (GT3X+ Activity Monitor, ActiGraph, Florida, USA) for a period of four days pre- and post-intervention. From the accelerometer, average daily step count, estimated energy expenditure and time spent engaged in sedentary, light, moderate, and vigorous physical activity will be determined as per our previous studies.
Timepoint [6] 370466 0
Pre- (week prior) and post (week after) the intervention.
Secondary outcome [7] 371847 0
Psychological need support during the exercise intervention will be assessed via a validated questionnaire (Markland & Tobin, 2010).
Timepoint [7] 371847 0
Immediately post-intervention
Secondary outcome [8] 371848 0
Motivation for exercise will be assessed via the validated Behavioural Regulation in Exercise Questionnaire-3.
Timepoint [8] 371848 0
One week pre- and immediately post-intervention.
Secondary outcome [9] 372112 0
Feelings of appetite will be assessed in response to exercise using a validated visual analogue scale. This requires participants to indicate their feelings of hunger along a 10 cm line.
Timepoint [9] 372112 0
One week pre- and immediately post-intervention.
Secondary outcome [10] 372113 0
Feelings of appetite will be assessed in response to exercise using a validated visual analogue scale. This requires participants to indicate their feelings of fullness along a 10 cm line.
Timepoint [10] 372113 0
One week pre- and immediately post-intervention.
Secondary outcome [11] 372116 0
Dietary restraint will be assessed via the Dutch Eating Behaviour Questionnaire,
Timepoint [11] 372116 0
One week pre- and immediately post-intervention.
Secondary outcome [12] 372117 0
Compensatory eating motives will be assessed via the Compensatory Eating Motives Questionnaire.
Timepoint [12] 372117 0
One week pre- and immediately post-intervention.

Eligibility
Key inclusion criteria
Participants will be eligible for participation if they are aged between 18 and 40 years and physically inactive, defined as performing less than 75 minutes of moderate to vigorous physical activity per week.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of medical conditions such as diabetes, hyperlipidaemia
- History of eating disorders known to affect appetite or restrained eaters (measured as scoring above 3.5 on the Dutch Eating Behaviour Questionnaire)
- Diet status which may interfere with food intake (e.g., on a weight-loss diet)
- Currently taking medication which could interfere with energy intake, appetite, or exercise
- Any known food allergies or dietary requirements (e.g., vegan)
- Injury or condition preventing exercise
- Pregnancy or breastfeeding
- Inability to attend the exercise sessions three times per week for 12 weeks

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)
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following the familiarisation session, participants will be pair-matched based on key physical characteristics (sex, age, fitness, body mass, and height). Within each pair, participants will be randomly allocated to the high-intensity intermittent exercise with need-support condition or the moderate-intensity continuous (standard-care) condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Participants will be blinded to the purpose of the study (i.e., assessment of energy intake in response to exercise) and instead be informed that the purpose of the study is to investigate the influence of regular exercise training on well-being and markers of stress in the body,
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two-way (time x condition) mixed-model ANOVAs will be conducted to determine treatment effects for all variables assessed at baseline and following the 12-week intervention, including body composition, energy intake post-exercise, appetite-related blood variables, and psychological factors. Post hoc analyses will be conducted where appropriate using Bonferroni adjustments.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2019
Actual
1/08/2019
Date of last participant enrolment
Anticipated
1/09/2020
Actual
15/09/2020
Date of last data collection
Anticipated
15/12/2020
Actual
23/12/2020
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302791 0
University
Name [1] 302791 0
The University of Western Australia
Country [1] 302791 0
Australia
Primary sponsor type
Individual
Name
Dr Kym Guelfi
Address
The University of Western Australia
School of Human Sciences
35 Stirling Highway
Crawley, WA, 6009
Country
Australia
Secondary sponsor category [1] 302737 0
None
Name [1] 302737 0
Address [1] 302737 0
Country [1] 302737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303382 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 303382 0
Ethics committee country [1] 303382 0
Australia
Date submitted for ethics approval [1] 303382 0
Approval date [1] 303382 0
17/09/2018
Ethics approval number [1] 303382 0

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

Contacts
Principal investigator
Name 93478 0
Dr Kym Guelfi
Address 93478 0
The University of Western Australia
School of Human Sciences
35 Stirling Highway
Crawley, WA, 6009
Country 93478 0
Australia
Phone 93478 0
+61 8 6488 2602
Fax 93478 0
Email 93478 0
[email protected]
Contact person for public queries
Name 93479 0
Natalya Beer
Address 93479 0
The University of Western Australia
School of Human Sciences
35 Stirling Highway
Crawley, WA, 6009
Country 93479 0
Australia
Phone 93479 0
+61 8 6488 2602
Fax 93479 0
Email 93479 0
[email protected]
Contact person for scientific queries
Name 93480 0
Natalya Beer
Address 93480 0
The University of Western Australia
School of Human Sciences
35 Stirling Highway
Crawley, WA, 6009
Country 93480 0
Australia
Phone 93480 0
+61 8 6488 2602
Fax 93480 0
Email 93480 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
Should data be requested at the time of journal submission, de-identified data will be made available


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.