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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]

Nil known

Universal Trial Number (UTN)

U1111-1181-4912

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Overweight

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

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]

Behaviour

Intervention code [2]

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]

Body composition (DXA)

Timepoint [1]

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]

waist circumference

Timepoint [2]

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]

body mass index (height and weight)

Timepoint [3]

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]

Cardiorespiratory fitness measured through indirect calorimetry. A VO2 peak test will be conducted using a modified Bruce protocol on a treadmill.

Timepoint [1]

Testing assessments will occur at baseline and post-intervention (week 13)

Secondary outcome [2]

Use of time (MARCA)

Timepoint [2]

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]

Resting metabolic rate (indirect calorimetry)

Timepoint [3]

RMR will be measured at baseline and post-intervention (week 13)

Secondary outcome [4]

Energy intake (24 hour food recalls)

Timepoint [4]

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]

Blood lipid profile (triglycerides, total cholesterol, HDL and LDL)

Timepoint [5]

Testing assessments will occur at baseline and post-intervention (week 13)

Secondary outcome [6]

Physical activity and sedentary behaviour (accelerometry)

Timepoint [6]

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]

food preferences - Leeds foods preferences questionnaire

Timepoint [7]

Food preferences will be measured at baseline, mid-intervention (week 6), and post-intervention (week 13)

Secondary outcome [8]

Dietary behaviour - three factor eating questionnaire (TFEQ)

Timepoint [8]

The TFEQ will be administered ood preferences will be measured at baseline and post-intervention.

Secondary outcome [9]

Chronotype - morningness eveningness questionnaire (MEQ)

Timepoint [9]

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]

Self-rated sleep quality (Pittsburgh sleep quality index (PSQI)

Timepoint [10]

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]

Appetite - visual analogue scales

Timepoint [11]

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

Sex

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

2/05/2016

Actual

6/06/2016

Date of last participant enrolment

Anticipated

3/07/2017

Actual

23/06/2017

Date of last data collection

Anticipated

30/03/2018

Actual

Sample size

Target

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Queensland

Address [1]

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]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Michael Leveritt

Address [1]

School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Sjaan Gomersall

Address [2]

School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Professor Neil King

Address [3]

School of Exercise and Nutrition Sciences
Cnr Musk and Victoria Park Rd
Queensland University of Technology
Kelvin Grove QLD 4059

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Limited

Ethics committee address [1]

129 Glen Osmond Road Eastwood South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2016

Approval date [1]

25/05/2016

Ethics approval number [1]

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

Miss Paige Brooker

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

Phone

+61 406773998

Fax

[email protected]

Contact person for public queries

Name

Paige Brooker

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

Phone

+61 406773998

Fax

[email protected]

Contact person for scientific queries

Name

Paige Brooker

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

Phone

+61 406773998

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		https://doi.org/10.1002/oby.23605
Study results article	Yes		DOI: 10.1123/jpah.2020-0802

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The feasibility and acceptability of morning versus evening exercise for overweight and obese adults: A randomized controlled trial.	2019	https://dx.doi.org/10.1016/j.conctc.2019.100320
Embase	The efficacy of morning versus evening exercise for weight loss: A randomized controlled trial.	2023	https://dx.doi.org/10.1002/oby.23605

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically