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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
21/04/2025
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.
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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
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Secondary ID [1]
313279
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
The TREx Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
335604
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Metabolic syndrome
335605
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Condition category
Condition code
Diet and Nutrition
332170
332170
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0
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Obesity
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Metabolic and Endocrine
332171
332171
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0
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329854
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Lifestyle
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Intervention code [2]
329965
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Treatment: Other
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Comparator / control treatment
The comparison group undertakes time-restricted eating only, and does not receive an exercise intervention
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Control group
Active
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Outcomes
Primary outcome [1]
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Adherence to the dietary and exercise interventions
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Assessment method [1]
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To evaluate adherence to TRE, participants will complete a very brief daily diary indicating whether they achieved the 9-hour TRE window, by recording the first and last time they ate each day. Similarly, for the exercise interventions, participants will be asked to record the type and duration of exercise sessions, Adherence to the exercise interventions will also assessed using the FitBit recordings.
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Timepoint [1]
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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.
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Primary outcome [2]
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Feasibility & acceptability of the interventions, as a composite outcome
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Assessment method [2]
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This will be assessed by evaluating the attrition rate overall and from each intervention arm. The source for these data will be records of study enrolment, and withdrawal logs and participants lost to follow up. We will also utilise qualitative data gathered in semi-structured interviews following the intervention period. Participants will be asked about their experiences of the interventions - questions will be designed specifically for this study.
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Timepoint [2]
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This outcome will be assessed immediately after the 12 week intervention has been completed.
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Secondary outcome [1]
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Anthropometry - BMI
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Assessment method [1]
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Height and weight taken using stadiometer and scales, using standardised duplicated procedure - this will be used to calculate a composite measure of BMI
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Timepoint [1]
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The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [2]
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Body composition - Fat-free mass
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Assessment method [2]
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Bioelectrical Impedance Analysis
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Timepoint [2]
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The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [3]
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Systolic/diastolic blood pressure
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Assessment method [3]
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Automated sphygmomanometer
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Timepoint [3]
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The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [4]
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Blood lipids - total cholesterol
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Assessment method [4]
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Venous blood test
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Timepoint [4]
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The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [5]
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Psychological wellbeing
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Assessment method [5]
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Standardised validated questionnaire of wellbeing (World Health organisation - Five Well-Being Index; WHO-5,)
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Timepoint [5]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [6]
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Glycated haemoglobin HbA1c
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Assessment method [6]
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Venous blood test
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Timepoint [6]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [7]
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C-Reactive Protein
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Assessment method [7]
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Venous Blood Test
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Timepoint [7]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [8]
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Psychological health
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Assessment method [8]
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Depression, Anxiety and Stress (DASS-21) questionnaire
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Timepoint [8]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [9]
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Eating behaviour
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Assessment method [9]
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Eating behaviours questionnaires (Self-Regulation of Eating Behaviour Questionnaire;SREBQ, and the Eating Disorder Examination Questionnaire - short; EDE-QS,)
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Timepoint [9]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [10]
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Sleep quality
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Assessment method [10]
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Sleep quality will also be assessed using actigraphy; participants will be asked to wear a wrist-based accelerometer at the same time-points (baseline and week 13)
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Timepoint [10]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [11]
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Anthropometry - weight
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Assessment method [11]
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Weight measured using scales, using standardised duplicated procedure
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Timepoint [11]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [12]
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Body composition - Percent body fat
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Assessment method [12]
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Bioelectrical Impedance Analysis
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Timepoint [12]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [13]
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Body composition - Fat mass
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Assessment method [13]
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Bioelectrical Impedance Analysis
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Timepoint [13]
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The measure will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [14]
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Sleep duration
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Assessment method [14]
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Sleep duration will be measured using actigraphy rather than Fitbits - participants will be asked to wear an actigraph at the same time points. These measures will be taken at baseline and at week 13 and will replace the Fitbit data for this purpose.
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Timepoint [14]
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Sleep duration will be assessed at baseline and following the intervention (week 13).
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Secondary outcome [15]
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Blood lipids - triglycerides
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Assessment method [15]
442209
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Venous blood test
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Timepoint [15]
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The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [16]
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Blood lipids - HDL cholesterol
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Assessment method [16]
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Venous blood test
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Timepoint [16]
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The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [17]
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Blood lipids - LDL cholesterol
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Assessment method [17]
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Venous blood test
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Timepoint [17]
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The measures will be taken at baseline, and immediately following the 12 week intervention period (week 13)
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Secondary outcome [18]
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Sleep timing
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Assessment method [18]
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B-PSQI questionnaire and wrist-worn actigraphy
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Timepoint [18]
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Measurements of sleep timing will be taken at baseline (week 0), and immediately after the intervention at week 13
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
24/01/2025
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Actual
27/01/2025
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Date of last participant enrolment
Anticipated
31/03/2025
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
60
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Accrual to date
51
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Final
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Recruitment outside Australia
Country [1]
26678
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New Zealand
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State/province [1]
26678
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Otago
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Otago Research Grant
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Address [1]
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Country [1]
317727
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New Zealand
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Funding source category [2]
317763
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Charities/Societies/Foundations
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Name [2]
317763
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Royal Australasian College of Physicians Research Fellowship Grant
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Address [2]
317763
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Country [2]
317763
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
320084
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Address [1]
320084
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Country [1]
320084
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Otago Human Ethics Committee (Health)
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Ethics committee address [1]
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https://www.otago.ac.nz/council/committees/committees/humanethicscommittees
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Ethics committee country [1]
316417
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New Zealand
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Date submitted for ethics approval [1]
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10/06/2024
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Approval date [1]
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05/07/2024
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Ethics approval number [1]
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H24/0167
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Summary
Brief summary
Time-restricted eating (TRE) is a novel approach to eating that limits the time during which you can eat each day to a 9-hour window. TRE is a simple lifestyle interventions that may help people lose weight, have better control of blood sugar, and improve overall health. Combining TRE with exercise might lead to even greater benefits and contribute to better appetite control and psychological wellbeing. This is a randomised controlled clinical trial of TRE with different forms of exercise (high intensity interval training, moderate intensity exercise, resistance training) in healthy adult participants, for 12 weeks. The aim of this study is to investigate whether people can adhere to TRE with exercise in their everyday lives, and to assess how well TRE and different types of exercise work as a combined lifestyle intervention to improve people’s health and wellbeing. It is hypothesised that combining TRE with any kind of exercise will enhance exercise and dietary adherence, and lead to superior health outcomes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Melyssa Roy
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Address
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Department of Medicine, University of Otago, PO Box 56, Dunedin 9054
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Country
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New Zealand
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Phone
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+642108167966
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Fax
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Email
137822
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[email protected]
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Contact person for public queries
Name
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Melyssa Roy
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Address
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Department of Medicine, University of Otago, PO Box 56, Dunedin 9054
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Country
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New Zealand
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Phone
137823
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+642108167966
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Fax
137823
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Email
137823
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[email protected]
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Contact person for scientific queries
Name
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Melyssa Roy
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Address
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Department of Medicine, University of Otago, PO Box 56, Dunedin 9054
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Country
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New Zealand
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Phone
137824
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+642108167966
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Fax
137824
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Email
137824
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No 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?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
UOHEC H_ApprovalLetter_6033_05_Jul_2024.pdf
Study protocol
Study protocol_TREx_v3.docx
Other
Information sheet
Participant Information Sheet_TREx_V2.docx
Informed consent form
Participant Consent Form_V2.docx
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.
Download to PDF