Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000807853
Ethics application status
Approved
Date submitted
5/05/2021
Date registered
25/06/2021
Date last updated
21/10/2022
Date data sharing statement initially provided
25/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Early Time Restricted Feeding with or without Multimodal Exercise on Type 2 Diabetes Risk Factors
Scientific title
Impact of Early Time Restricted Feeding with or without Multimodal Exercise on Type 2 Diabetes Risk Factors in At-Risk Adults.
Secondary ID [1] 304098 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 321767 0
Obesity 322171 0
Overweight 322172 0
Physical Inactivity 322173 0
Condition category
Condition code
Metabolic and Endocrine 319505 319505 0 0
Diabetes
Diet and Nutrition 319858 319858 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Design:
Potential Participants will be initially screened by the primary investigator. Successful applicants will then be invited to the Exercise Physiology Clinic at Murdoch University for the collection of preliminary baseline measurements following the attainment of written informed consent. This study will adopt a two-week Randomised Controlled Trial design with participants randomly allocated to an Early Time Restricted Feeding intervention either with or without Multimodal Exercise. A two-week control period which will involve all participants will proceed prior to randomisation and allocation to assess the outcome measures for the study.

Procedure:
Participants from both groups will be required to complete the Early Time Restricted Feeding protocol. This will last for the duration of the intervention period (2-weeks). Throughout this 2-week time period, participants will be required to eat within an 8-hour feeding window prior to a >5-hour fasting period prior to sleep. Participants will be encouraged to maintain a similar dietary regime during the study to which they would normally eat in a regular day-to-day basis, inclusive of their diet and caloric intake. This information will be delivered in person at Murdoch University by the primary investigator, a newly graduated exercise physiologist.

Those randomly allocated to the Early Time Restricted Feeding WITH Multimodal Exercise group will have to complete multimodal exercise in addition to completing the Early Time Restricted Feeding protocol. This Exercise program will occur in the >5-hour fasting window after eating and prior to sleep. The exercise intervention will occur on 12 of the 14 day intervention period for roughly 1-hour 30 mins each session. The Exercise Intervention will consist of Face-to-Face gym sessions and online Telehealth sessions via Microsoft Teams; all monitored by the primary investigator; an exercise physiologist.

A familiarisation session will occur prior to day 1 of the intervention to educate participants on correct movement patterns and intensity of all exercises. The first 2 days and the last day of the 14 day intervention will consist of Face-to-Face gym sessions at Murdoch University to aid in the correction exercise technique and educating exercise intensity, while also providing the participants with a briefing/debriefing opportunity. As this study looks at real life implementation, the participants are free to decide how they would like to implement the remaining 11 days of the intervention, which will consist of 6 Telehealth sessions, 3 face-to-face gym sessions and 2 rest days.
Additionally, face-to-face gym sessions will alternate between a session 1 (bench press, leg press, strict overhead press, leg extensions and triceps push downs) and session 2 (lat pull-downs, trap-bar dead-lifts, single arm cable rows, leg curls and biceps curls) to exercise all areas of the body. Telehealth exercises will include: sit-to-stands, counter-top push-ups, lunges, glute bridges and high plank holds.

Participants will be required to complete 3x10 sets x repetitions for all gym exercises with a resistance weight to elicit 4-5 repetitions remaining for each set. Similarly for online Telehealth sessions, participants will be required to complete as many repetitions as needed to elicit 4-5 repetitions remaining for each set, completing 3 sets. All the above resistance exercises will need to be completed at a moderate-high intensity. This will be decided on a 1-10 scale, where 6/10 elicits the 4-5 repetition remaining required, visual referencing will be used for participants as well.
Participants will also have to complete 30 minutes of aerobic exercise (walking) each exercise session; treadmill optional. This aerobic exercise will need to be completed in a moderate to high intensity (14/20 RPE).

The exercise program will be administered in either a one-on-one setting or in a group setting, this depends on what days the participants will attend the face-to-face gym sessions and at what time they are attending depending on their own specific Early Time Restricted Feeding Protocol. Additionally, as adherence to the study is key, a session attendance checklist will be developed for each participant, allowing for close monitoring of the participants and how they are progressing with their sessions.
Intervention code [1] 320427 0
Treatment: Other
Intervention code [2] 320428 0
Prevention
Comparator / control treatment
Comparison between the two intervention groups (i.e. Early Time Restricted Feeding and Early Time Restricted Feeding with Multimodal Exercise) with the Early Time Restricted Feeding group acting as the comparator.
Participants in the Early Time Restricted Feeding group will be advised to maintain similar physical activity levels during the study to which they would normally complete in their day-to-day life.
Control group
Active

Outcomes
Primary outcome [1] 327371 0
Change in Fasting Blood Glucose levels assessed from blood samples
Timepoint [1] 327371 0
Baseline, two days post-completion of the intervention
Secondary outcome [1] 394819 0
Change in Fasting Blood Insulin levels assessed from blood samples
Timepoint [1] 394819 0
Baseline, two days post-completion of the intervention
Secondary outcome [2] 394821 0
Change in Circadian Rhythm Shift assessed via an ibutton thermachron for diurnal wrist skin temperature for the measurement of circadian rhythm.
Timepoint [2] 394821 0
Daily throughout the two week control period sampled every 12 minutes, Daily throughout the two week intervention period sampled every 12 minutes.
Secondary outcome [3] 394822 0
Change in Whole Body Composition assessed with the use of a DXA Analysis
Timepoint [3] 394822 0
Baseline, two days post-completion of the intervention.
Secondary outcome [4] 394823 0
Change in Body Anthropometrics of weight (kg) assessed with digital scales.
Timepoint [4] 394823 0
Baseline, two days post-completion of the intervention
Secondary outcome [5] 394824 0
Change in Dietary Analysis assessed through past 24-h dietary recalls, these will be conducted in a structured interview setting and through phone calls.
Timepoint [5] 394824 0
3x during the two week control period (2x weekday, 1x weekend), 3x during the two week intervention period (2x weekday, 1x weekend).
Secondary outcome [6] 394907 0
Change in sleep quantity and quality assessed by wearing an ActiGraph. This is a Composite Secondary Outcome.
Timepoint [6] 394907 0
Continuous daily monitoring throughout the 2-week control period, Continuous daily monitoring throughout the 2-week intervention period.
Secondary outcome [7] 394917 0
Change in body Anthropometrics of waist circumference (cm) assessed by the horizontal displacement around the belly button measured by a tape measure.
Timepoint [7] 394917 0
Baseline, two days post-completion of the intervention
Secondary outcome [8] 394919 0
Change in dietary analysis assessed through the 3-Factor Eating Questionnaire
Timepoint [8] 394919 0
Baseline, two weeks post-completion of the intervention
Secondary outcome [9] 394920 0
Change in dietary analysis assessed through dietary composition which will be analysed on FoodWorks after the structured interview setting and phone call 24-h dietary recalls
Timepoint [9] 394920 0
3x during the two week control period (2x weekday, 1x weekend), 3x during the two week intervention period (2x weekday, 1x weekend).
Secondary outcome [10] 396493 0
Physical Activity measured by the wearing of an ActiGraph, this will be measured as a Composite Secondary Outcome.
Timepoint [10] 396493 0
Continuous daily monitoring throughout the 2-week control period, Continuous daily monitoring throughout the 2-week intervention period.
Secondary outcome [11] 396494 0
Sleep Quality assessed through the Pittsburgh Sleep Quality Index, this is a Composite Secondary Outcome measure.
Timepoint [11] 396494 0
Baseline, two days post-completion of the intervention

Eligibility
Key inclusion criteria
Age greater and/or equal to 18
BMI greater and/or equal to 27
Physical activity <90mins per week.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently taking insulin
Currently using specific contraceptives (Implanon, Mirena IUD, the Pill
Tobacco smoking
2 or more standard drinks of alcohol per day
Prior/present: Heart, Lung, Kidney, Liver, Endocrine Disease
Currently work night shift
Currently diabetic

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 will be blinded and conducted by a third party investigator using block randomisation sequences for males and females. This will be conducted in a 1:1 treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked Randomisation Sequence instigated by the third party investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
26 Participants are required, determined using the following parameters:
These were identified with the Primary Outcome Measure of Fasting Blood Glucose Estimates
Early Time Restricted Feeding: 5.8 mmol and 5.6 mmol pre to post;
Early Time Restricted Feeding plus Multimodal Exercise: 5.9 mmol and 5.4 mmol pre to post;
SD: 0.25; power: 0.8; alpha: 0.05)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/11/2022
Actual
Date of last participant enrolment
Anticipated
25/08/2023
Actual
Date of last data collection
Anticipated
22/09/2023
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308484 0
University
Name [1] 308484 0
Murdoch University
Country [1] 308484 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch. 6150, WA
Country
Australia
Secondary sponsor category [1] 309328 0
None
Name [1] 309328 0
Address [1] 309328 0
Country [1] 309328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308435 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 308435 0
Ethics committee country [1] 308435 0
Australia
Date submitted for ethics approval [1] 308435 0
03/05/2021
Approval date [1] 308435 0
14/07/2021
Ethics approval number [1] 308435 0

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

Contacts
Principal investigator
Name 110702 0
A/Prof Timothy Fairchild
Address 110702 0
90 South Street, Murdoch, 6150, WA.
Murdoch University
Country 110702 0
Australia
Phone 110702 0
+61432519154
Fax 110702 0
Email 110702 0
[email protected]
Contact person for public queries
Name 110703 0
Shaun Teo
Address 110703 0
90 South Street, Murdoch, 6150, WA.
Murdoch University
Country 110703 0
Australia
Phone 110703 0
+61423716780
Fax 110703 0
Email 110703 0
[email protected]
Contact person for scientific queries
Name 110704 0
Shaun Teo
Address 110704 0
90 South Street, Murdoch, 6150, WA.
Murdoch University
Country 110704 0
Australia
Phone 110704 0
+61423716780
Fax 110704 0
Email 110704 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


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.