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Trial registered on ANZCTR


Registration number
ACTRN12616000457448
Ethics application status
Approved
Date submitted
1/04/2016
Date registered
7/04/2016
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Morning versus evening exercise: Its effect on body composition and weight loss
Scientific title
Is there a difference in the amount of weight lost when exercise is performed in the morning compared to the evening, as part of a lifestyle intervention, in insufficiently active, overweight and obese adults.
Secondary ID [1] 288628 0
Nil known
Universal Trial Number (UTN)
U1111-1181-4912
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 297786 0
Obesity 297787 0
Condition category
Condition code
Diet and Nutrition 297970 297970 0 0
Obesity
Public Health 297971 297971 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a multi-armed, randomised controlled trial design, with a 12-week lifestyle intervention. Following recruitment and screening, participants will complete baseline assessments and will then be randomised into one of two intervention groups, or the waitlist Control group. The primary component of the intervention is exercise, incorporating both supervised and unsupervised sessions. The two intervention conditions will be given the same instructions and encouragement, and differ only by the dedicated time slot to complete exercise; that is, in the morning, or in the evening.

During the 12-week intervention participants will be prescribed 250 minutes of moderate-vigorous exercise per week, as recommended by the ACSM (2011) to elicit clinically significant weight loss. There will be no caveats to restrict additional exercise outside of the intervention, however, participants must complete the minimum dose of exercise during their respective time frame, conducive to their group allocation. That is, the AMEx group must complete minimum of 250 minutes of exercise between 0600 – 0900 h, and the PMEx group must complete =250 minutes of exercise between 1600 – 1900 h. These time periods were chosen to coincide with diurnal hormone patterns, and for convenience based on when most people could accommodate exercise (i.e. before or after work) (Blonc et al., 2010; Maraki et al., 2005).

The exercise programme will comprise both instructor-supervised and unsupervised individual exercise sessions. Participants will complete an initial four-week supervised exercise training phase, with 5 sessions per week of 50 minutes. Phase 1 will involve four weeks of supervised exercise training, with 5 sessions per week to meet the minimum dose. Phase 2 will be eight weeks in duration and will involve a combination of supervised and unsupervised exercise sessions, tapering the supervised sessions from four times per week to twice per week. Weeks 5-6: 4 supervised sessions, weeks 7-8: 3 supervised sessions, weeks 9-12: 2 supervised sessions.

Supervised sessions will consist of brisk walking or running on a motor-driven treadmill for approximately 50 minutes, at a self-selected intensity. All sessions will include a 10-minute warm-up and a 10-minute cool-down/stretching period. RPE will be recorded using the 6- to 20-point Borg scale (Borg, 1985) at the end of warm-up, during the session and at the end of the session (before cool-down). Participants are free to undertake other aerobic activities of their choice during the unsupervised sessions. Both intervention groups will receive the same instructions during the exercise sessions, including verbal encouragement and equal motivation.

All supervised exercise sessions will be performed in the exercise laboratory at the Univerity of Queensland.

To assist individuals achieve weight loss, the secondary component of the intervention will involve several constituents of behaviour change, including
1. self-monitoring:
Participants will record their behaviour using exercise diaries and HR monitors. The act of keeping daily records requires conscious thought about activity levels and serves as a reminder to exercise (Gleeson-Kreig, 2006). Additionally, participants will weight themselves weekly to promote weight loss and reduce the risk of weight regain (Burke et al., 2011; Racette et al., 2006).
2. goal setting: Participants will be taught goal-setting techniques during the first week of the intervention. Following their first supervised exercise session, participants will be familiarised with the S.M.A.R.T technique (Specific, Measurable, Attainable, Relevant and Timely) to ensure the goals will likely be attained. Participants will be provided with written guidelines explaining the SMART principles so they have something to refer back to throughout the intervention, and will be instructed to set weekly goals to increase their energy expenditure, (both the intensity and dose). During the supervised exercise sessions, participants will self-select their work rate and the caloric expenditure will be visible on the treadmill.
3. education: Participants will be given instructions, feedback and guidance about use of exercise equipment, exercise technique, and recognising cues for injury avoidance. Participants will also be provided with a booklet containing the Australian Dietary Guidelines and pictures to accurately measure food portion sizes prior to the start of the intervention.
4. encouragement and support: Data from participants HR monitors will be downloaded weekly. During this time, participants will be asked about their progress and any potential barriers to exercise will be identified and methods to help overcome them will be discussed.
5. Prompting: Participants will be sent email/text message reminders to attend their supervised exercise sessions. After their session, participants will be prompted to incorporate some active transport or active leisure time each week. During phase 2, participants will be reminded to complete the required dose of unsupervised exercise.

All education, encouragement and motivation will be standardised across the intervention groups.

Adherence to the intervention will be assessed by recording attendance to supervised sessions, self-reported exercise diaries and data downloaded from heart rate monitors.
Intervention code [1] 294034 0
Behaviour
Intervention code [2] 294035 0
Lifestyle
Comparator / control treatment
Participants randomised to the Control group will undertake similar same outcome testing measures to the intervention groups, but given no specific instructions other than to continue with their typical everyday activities. They will be wait-listed to receive the exercise programme upon completion of all study assessments and allowed to choose whether they would like to exercise in either the morning, or in the evening.
Control group
Active

Outcomes
Primary outcome [1] 297493 0
Body composition (DXA)
Timepoint [1] 297493 0
A DXA scan will be performed at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (3- and 6-months post intervention completion)
Primary outcome [2] 297878 0
waist circumference
Timepoint [2] 297878 0
Waist circumference will be measured at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (3- and 6-months post intervention completion)
Primary outcome [3] 297879 0
body mass index (height and weight)
Timepoint [3] 297879 0
Body mass index will be measured at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (3- and 6-months post intervention completion)
Secondary outcome [1] 321206 0
Cardiorespiratory fitness measured through indirect calorimetry. A VO2 peak test will be conducted using a modified Bruce protocol on a treadmill.
Timepoint [1] 321206 0
Testing assessments will occur at baseline and post-intervention (week 13)
Secondary outcome [2] 321207 0
Use of time (MARCA)
Timepoint [2] 321207 0
MARCA will be administered at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (3- and 6-months post intervention completion)
Secondary outcome [3] 321208 0
Resting metabolic rate (indirect calorimetry)
Timepoint [3] 321208 0
RMR will be measured at baseline and post-intervention (week 13)
Secondary outcome [4] 322469 0
Energy intake (24 hour food recalls)
Timepoint [4] 322469 0
Energy intake will be measured at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (3- and 6-months post intervention completion)

.
Secondary outcome [5] 322506 0
Blood lipid profile (triglycerides, total cholesterol, HDL and LDL)
Timepoint [5] 322506 0
Testing assessments will occur at baseline and post-intervention (week 13)
Secondary outcome [6] 322507 0
Physical activity and sedentary behaviour (accelerometry)
Timepoint [6] 322507 0
Activity (physical activity and sedentary behaviour) will be measured at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (3- and 6-months post intervention completion)
Secondary outcome [7] 322508 0
food preferences - Leeds foods preferences questionnaire
Timepoint [7] 322508 0
Food preferences will be measured at baseline, mid-intervention (week 6), and post-intervention (week 13)
Secondary outcome [8] 322509 0
Dietary behaviour - three factor eating questionnaire (TFEQ)
Timepoint [8] 322509 0
The TFEQ will be administered ood preferences will be measured at baseline and post-intervention.
Secondary outcome [9] 322510 0
Chronotype - morningness eveningness questionnaire (MEQ)
Timepoint [9] 322510 0
The MEQ will be administered at baseline, post-intervention (week 13) and at follow-up (3- and 6-months post intervention completion)
Secondary outcome [10] 322511 0
Self-rated sleep quality (Pittsburgh sleep quality index (PSQI)
Timepoint [10] 322511 0
PSQI will be administered at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (3- and 6-months post intervention completion)
Secondary outcome [11] 322512 0
Appetite - visual analogue scales
Timepoint [11] 322512 0
Appetite will be assessed at baseline, mid-intervention (week 6), post-intervention (week 13)

Eligibility
Key inclusion criteria
Participants will be recruited based on the following inclusion criteria:
i. be aged between 18 and 60 years
ii. have a body mass index greater than or equal to 25 kg/m2
iii. be insufficiently active, defined as participating in less than 150 minutes of MVPA per week (by self-report)
iv. have been weight stable in the previous 3 months (+/-3 kg by self-report)
v. otherwise healthy and cleared for exercise based on the Exercise and Sports Science Australia Adult Pre-Exercise Screening System

Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded based on any of the following criteria:
i. participate in shift work
ii. are pregnant or expecting to be pregnant during the study period
iii. taking any medication that would affect food intake, appetite or physical activity levels, weight loss, or metabolism
iv. have a body weight greater than 150 kg, due to limitations of the DXA machine


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)
Due to the nature of the exercise intervention, it is not possible to blind the participants to group allocation, however, participants will be blinded to the time-of-day hypothesis to prevent any influence on study outcomes. Similarly, it is not feasible to blind the principal investigator to participants’ group allocation as she will be both supervising exercise sessions, and conducting all measurements.
The allocation will be concealed through central randomisation by computer, and provided to the principal investigator via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After completing baseline measures, participants will be randomly allocated to one of three groups; morning exercise group (AMEx), evening exercise group (PMEx) or the Control group (CON), on a 2:2:1 ratio using permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be recorded and stored in a master spreadsheet in Microsoft Excel and variables of interest will be imported and analysed in the SPSS statistical software package (version 23.0, SPSS Inc., Chicago, Illinois). Demographic data will be analysed using standard descriptive statistics. Group characteristics at baseline will be summarised, but not tested for differences, as per the 2010 CONSORT statement (de Boer, 2015).

To address the aims of the study and compare the mean changes in outcome variables between groups (AMEx, PMEx, CON) x time (0, 6, 12, 24 and 36 weeks), generalised linear mixed modelling will be used and alpha will be set at 0.05. An intention-to-treat analysis will be employed to present an unbiased estimate of the effect of the intervention as a result of possible differences in drop-outs between groups and the unequal allocation.

An a priori power calculation at 5% alpha level and 80% power determined that a total sample of 69 participants would be sufficient to detect small effect sizes (Cohen’s d =0.3) for within- and between-groups differences with five measurement occasions, and small to moderate effect sizes (Cohen’s d=0.4), for measures collected twice (G*Power software, version 3.1.9.2, University of Düsseldorf, Düsseldorf, Germany).
.
Unequal allocation has consequences on statistical power. To detect the same effect size with equivalent power, a 2:1 allocation sequence requires 12% more participants than the typical 1:1 (Dibao-Dina et al., 2014; Hey & Kimmelman, 2014; Meinert & Tonascia, 1986). Therefore, the required total sample size would be increased to 78 participants. In addition, due to documented drop-out rates among exercise and lifestyle interventions (Dunn et al., 1999; Groeneveld et al., 2009; Mutsaerts et al., 2013) and the high participant burden, we anticipate a drop-out rate of 20%. Therefore, a target sample size of 95 participants will be set for recruitment; n=19 in the Control group and n=38 in each intervention group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292987 0
University
Name [1] 292987 0
The University of Queensland
Address [1] 292987 0
School of Human Movement and Nutrition Sciences (#26B)
Cnr Blair Drive & Union Road
The University of Queensland, St Lucia Campus
Brisbane Qld 4072
Country [1] 292987 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Human Movement and Nutrition Sciences (#26B)
Cnr Blair Drive & Union Road
The University of Queensland, St Lucia Campus
Brisbane Qld 4072
Country
Australia
Secondary sponsor category [1] 291759 0
None
Name [1] 291759 0
Address [1] 291759 0
Country [1] 291759 0
Other collaborator category [1] 278928 0
Individual
Name [1] 278928 0
Dr Michael Leveritt
Address [1] 278928 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [1] 278928 0
Australia
Other collaborator category [2] 278929 0
Individual
Name [2] 278929 0
Dr Sjaan Gomersall
Address [2] 278929 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [2] 278929 0
Australia
Other collaborator category [3] 278930 0
Individual
Name [3] 278930 0
Professor Neil King
Address [3] 278930 0
School of Exercise and Nutrition Sciences
Cnr Musk and Victoria Park Rd
Queensland University of Technology
Kelvin Grove QLD 4059
Country [3] 278930 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294495 0
Bellberry Limited
Ethics committee address [1] 294495 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 294495 0
Australia
Date submitted for ethics approval [1] 294495 0
08/04/2016
Approval date [1] 294495 0
25/05/2016
Ethics approval number [1] 294495 0

Summary
Brief summary
Overweight individuals use exercise primarily as a means to reduce body weight. Given the continued rise in the prevalence of overweight and obesity (Hill et al., 2012; Ziauddeen et al., 2015), optimising the benefits of exercise for weight loss is crucial. In recognition of this, evidence-based recommendations for exercise prescription including frequency, intensity, mode, duration, pattern, and volume have been developed (Donnelly et al., 2009; Garber et al., 2011). Similarly, some countries have established guidelines for minimum physical activity levels required for weight maintenance and weight loss (Donnelly et al., 2009; insert OZ ref). However, there is no such recommendation for the optimal time-of-day at which exercise should be performed to maximise its impact on weight loss.

Circadian rhythms regulate several physiological processes that influence appetite, sleep/wake cycles and exercise performance (Almoosawi et al., 2013; Drust et al., 2005; Froy, 2007; Thun et al., 2015; Winget et al., 1985; Youngstedt et al., 2002), therefore, it is possible that individuals will respond differently when exercise is performed in the morning, compared to the evening. However, the majority of available exercise-based weight loss research either does not control, or does not report, the time-of-day at which exercise has been prescribed. Therefore, the implications of exercise time-of-day for weight loss are unknown.

The aim of this chapter is to present an overview of the available literature including observational and experimental studies in the area of exercise timing and its potential effects on body weight and composition. Additionally, some discussion surrounding the physiological responses to exercise and circadian rhythm of hormones will be presented to provide additional insight to understand the mechanisms behind the time-of-day effect on body weight and composition
Trial website
http://exercisetimeofday.wix.com/paige
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63918 0
Miss Paige Brooker
Address 63918 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road,
The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country 63918 0
Australia
Phone 63918 0
+61 406773998
Fax 63918 0
Email 63918 0
p.brooker@uq.edu.au
Contact person for public queries
Name 63919 0
Miss Paige Brooker
Address 63919 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road,
The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country 63919 0
Australia
Phone 63919 0
+61 406773998
Fax 63919 0
Email 63919 0
p.brooker@uq.edu.au
Contact person for scientific queries
Name 63920 0
Miss Paige Brooker
Address 63920 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road,
The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country 63920 0
Australia
Phone 63920 0
+61 406773998
Fax 63920 0
Email 63920 0
p.brooker@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary