Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001406594
Ethics application status
Approved
Date submitted
6/11/2024
Date registered
28/11/2024
Date last updated
28/11/2024
Date data sharing statement initially provided
28/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Time for health: Investigating the real-world impact of time-restricted eating with exercise on health and well-being.
Scientific title
Time for health: Investigating the feasibility and health outcomes of time-restricted eating with exercise on health and well-being in healthy adults
Secondary ID [1] 313279 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The TREx Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 335604 0
Metabolic syndrome 335605 0
Condition category
Condition code
Diet and Nutrition 332170 332170 0 0
Obesity
Metabolic and Endocrine 332171 332171 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions have a dietary component - with all participants undertaking time-restricted eating (TRE) with a 9 hour eating window, alongside an exercise component, with participants randomised to either high-intensity interval training, moderate intensity exercise, resistance training.
Thus, the interventions groups are comprised of:
TRE with High-Intensity Interval Training
TRE with Moderate Intensity Exercise
TRE with Resistance Training Exercise

Dietary Intervention – Time-Restricted Eating
All groups will be instructed to undertake TRE during the intervention phase. This involves limiting energy intake to a 9-hour window each day. Participants will be instructed to not consume any food after 8pm as this can disrupt circadian rhythm, thus the 9-hour eating windows can be any time before this (e.g., 9.30am-6.30pm, or 11am-8pm). No other dietary restrictions or recommendations will be made. Participants may consume non-caloric beverages outside of the eating window.

Exercise Interventions
To better represent how people undertake HIIT, MIE and resistance training exercise in the real-world, all participants will be offered a 12-week gym membership in which they can undertake their exercise interventions safely as group fitness classes and/or by utilising gym equipment.

TRE with High-Intensity Interval Training (HIIT): Participants in the TRE with HIIT group will undertake TRE and be instructed to undertake HIIT three times per week. High intensity exercise is defined as “exercise that uses most of your body and is very hard to do within seconds.” HIIT typically involves short intervals (ranging from 20 seconds to 4 minutes) of hard exercise, interspersed with short periods of light activity. It is expected that each HIIT session will take between 30-45 minutes to complete. Participants should attain a rating of perceived exertion of at least 7-8 on a 10-point scale - perceived exertion is known to effectively guide exercise intensity and is routinely used in exercise guidelines.
Participants can opt to do group HIIT classes, which is consistent with how many people achieve HIIT in the real-world. It is expected that most participants will utilise this option, during which the gym fitness instructor will provide the guidance on how to undertake HIIT. The recommended HIIT classes will include cycle classes with sprint intervals, mixed martial arts classes that include exercises such as kickboxing and burpees, and high-intensity functional movement classes that utilise bodyweight exercises, weights and steps. Participants will also receive written guidance on how to undertake independent HIIT if they prefer; this will be explained by the researcher at the first 60 minutes intervention visit. Participants can choose to do HIIT independently by hill or stair climbing, sprinting, using cardio exercise equipment such as rowing machines, or home-based exercises such as star jumps, burpees and high-knee running. A range of validated HIIT protocols (such as 5 x 60 second intervals aiming for RPE of 9) will be included in the resources.
Participants will be given a FitBit in weeks 1, 6 and 12. They may use the FitBits to monitor their heart rate (a target heart rate of 80% of their estimated maximum will be calculated for them based on age) to help aid in attaining sufficient intensity. Fitbit recordings of HIIT sessions will be reviewed to assess if the correct level of intensity has been attained. Adherence to HIIT training will also be measured by the exercise diaries as described in the outcomes section.

TRE with Moderate Intensity Exercise (MIE): Participants in the MIE group will undertake TRE and be advised to undertake at least 30 minutes of moderate physical activity on most days of the week, as per current New Zealand exercise guidelines. Moderate intensity exercise should be continuous and performed at an intensity of 5-6 on a 10-point scale – an effort that leads to breathing harder but still being able to maintain a conversation. Participants in the MIE group can utilise their gym membership to access exercise equipment such as elliptical trainers and rowing machines, and participants will be instructed as to which group fitness classes are suitable to support MIE, such as cycle classes. Participants may also undertake MIE outside of the gym with activities such as brisk walking, jogging, cycling or swimming. Adherence to the MIE exercise intervention will be recorded on weeks 1, 6 and 12 by the participants in the exercise diaries, and FitBit recordings will be reviewed to assess adherence and intensity.

TRE with Resistance Training Exercise (RT): Participants in the resistance training exercise group will undertake TRE and be advised to undertake resistance training exercise. Participants in this group will perform resistance training at least three times a week for 30-60 minutes. Again, participants can opt to utilise group fitness classes that provide guided resistance training - these classes last 30-60 minutes and typically train all major muscle groups utilising barbells and weight plates, with standard exercises such as squats, lunges, chest press, barbell rows, clean and press. If participants prefer, they may utilise appropriate gym equipment for weight training using the same types of exercises.
Adherence to the RT intervention will also be assessed by participant exercise diaries on weeks 1, 6 and 12.
Intervention code [1] 329854 0
Lifestyle
Intervention code [2] 329965 0
Treatment: Other
Comparator / control treatment
The comparison group undertakes time-restricted eating only, and does not receive an exercise intervention
Control group
Active

Outcomes
Primary outcome [1] 339804 0
Adherence to the dietary and exercise interventions
Timepoint [1] 339804 0
Measures of TRE and exercise adherence will be taken for a week, on weeks 1, 6 and 12 of the intervention period.
This survey will be delivered via automated text reminder.
The FitBits will also be worn for a week at weeks 1, 6 and 12 of the intervention period.
Primary outcome [2] 339891 0
Feasibility & acceptability of the interventions, as a composite outcome
Timepoint [2] 339891 0
This outcome will be assessed immediately after the 12 week intervention has been completed.
Secondary outcome [1] 441421 0
Anthropometry - BMI
Timepoint [1] 441421 0
The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [2] 441422 0
Body composition - Fat-free mass
Timepoint [2] 441422 0
The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [3] 441423 0
Systolic/diastolic blood pressure
Timepoint [3] 441423 0
The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [4] 441424 0
Blood lipids - total cholesterol
Timepoint [4] 441424 0
The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [5] 441425 0
Psychological wellbeing
Timepoint [5] 441425 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [6] 441807 0
Glycated haemoglobin HbA1c
Timepoint [6] 441807 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [7] 441808 0
C-Reactive Protein
Timepoint [7] 441808 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [8] 441809 0
Psychological health
Timepoint [8] 441809 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [9] 441810 0
Eating behaviour
Timepoint [9] 441810 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [10] 441811 0
Sleep quality
Timepoint [10] 441811 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [11] 442204 0
Anthropometry - weight
Timepoint [11] 442204 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [12] 442206 0
Body composition - Percent body fat
Timepoint [12] 442206 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [13] 442207 0
Body composition - Fat mass
Timepoint [13] 442207 0
The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [14] 442208 0
Sleep duration
Timepoint [14] 442208 0
Fitbit data are collected for a week prior to the intervention (week 0), then at weeks 1, 6 and 12 of the intervention.
The questionnaire will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [15] 442209 0
Blood lipids - triglycerides
Timepoint [15] 442209 0
The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [16] 442210 0
Blood lipids - HDL cholesterol
Timepoint [16] 442210 0
The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
Secondary outcome [17] 442211 0
Blood lipids - LDL cholesterol
Timepoint [17] 442211 0
The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)

Eligibility
Key inclusion criteria
Eligible healthy participants will be adults (18 years and older) who are of normal weight or overweight/obese (BMI of greater than or equal to 19). Because TRE and exercise can be beneficial for all people, participants may be healthy, or with lifestyle modifiable conditions such as pre-diabetes and controlled hypertension.
To safely undertake HIIT, participants who are aged over 45 years need to be already doing some physical activity on a regular basis, so screening will also include an assessment of current physical activity levels.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusions will occur for people with type 1 and 2 diabetes, shift workers, those who are pregnant, breastfeeding mothers, those on medications affecting glucose, those on medications that must be had with food, those with eating disorders, or those with significant cardiovascular or medical conditions that prevent them safely taking part in high intensity exercise.

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)
Following inclusion into the trial, participants will be allocated randomly in a 1:1 ratio to one of four intervention groups, using the REDCap randomisation module. Allocation group will not be concealed from the investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Fifteen participants will each be randomly allocated in a 1:1 ratio to one of four intervention groups, using the REDCap randomisation module. Randomisation will be stratified by sex.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Initial analyses will be performed in accordance with intention-to-treat principles (based on group randomised and using all available data without inputting values missing at random). Continuous variables, such as weight,will be considered within a generalised linear model with an identity link function. Categorical variables will be considered with an appropriate link function depending on the nature of the categorical variable, for example binary variables will use a logit link function. Some outcomes may require log transformation prior to analyses.

Missing data will be investigated to see if the pattern is different by intervention arm or participant baseline characteristics. Missing outcome data will be investigated with a best case/worst case analysis as a sensitivity analysis for the primary analysis (by randomised arm). For the statistical models any important confounders (i.e. body mass) that show substantial differences at baseline will be included in the analysis to adjust out any residual confounding. Given the challenges of adjusting for multiple outcomes particularly with potentially highly correlated outcomes, no adjustments will be made, however, all secondary outcomes will be interpreted with caution with a focus on the estimate with 95% confidence intervals. It will also be important to interpret effects (and confidence intervals) in terms of clinical importance rather than purely on the p-value alone.

A per protocol analysis will also be undertaken to investigate how adherence with the intervention impacts the results, as well as investigation of any dose response relationship. Exploratory analyses may be conducted separately to generate future hypotheses or answer future research questions. Reporting will adhere to all items in the CONSORT statement, including a CONSORT flow diagram showing participant flow and reasons for exclusion and loss to follow-up where available. Analyses will be undertaken in Stata.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26678 0
New Zealand
State/province [1] 26678 0
Otago

Funding & Sponsors
Funding source category [1] 317727 0
University
Name [1] 317727 0
University of Otago Research Grant
Country [1] 317727 0
New Zealand
Funding source category [2] 317763 0
Charities/Societies/Foundations
Name [2] 317763 0
Royal Australasian College of Physicians Research Fellowship Grant
Country [2] 317763 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 320084 0
None
Name [1] 320084 0
Address [1] 320084 0
Country [1] 320084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316417 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 316417 0
Ethics committee country [1] 316417 0
New Zealand
Date submitted for ethics approval [1] 316417 0
10/06/2024
Approval date [1] 316417 0
05/07/2024
Ethics approval number [1] 316417 0
H24/0167

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

Contacts
Principal investigator
Name 137822 0
Dr Melyssa Roy
Address 137822 0
Department of Medicine, University of Otago, PO Box 56, Dunedin 9054
Country 137822 0
New Zealand
Phone 137822 0
+642108167966
Fax 137822 0
Email 137822 0
melyssa.roy@otago.ac.nz
Contact person for public queries
Name 137823 0
Melyssa Roy
Address 137823 0
Department of Medicine, University of Otago, PO Box 56, Dunedin 9054
Country 137823 0
New Zealand
Phone 137823 0
+642108167966
Fax 137823 0
Email 137823 0
melyssa.roy@otago.ac.nz
Contact person for scientific queries
Name 137824 0
Melyssa Roy
Address 137824 0
Department of Medicine, University of Otago, PO Box 56, Dunedin 9054
Country 137824 0
New Zealand
Phone 137824 0
+642108167966
Fax 137824 0
Email 137824 0
melyssa.roy@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only the named investigators will have access to the information collected from participants in this study. All data will be anonymised and aggregated for analysis.
Study data will be collected and managed using REDCap (Research Electronic Data Capture), hosted at the University of Otago.


What supporting documents are/will be available?




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.