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Trial registered on ANZCTR


Registration number
ACTRN12620000453987
Ethics application status
Approved
Date submitted
13/03/2020
Date registered
8/04/2020
Date last updated
8/04/2020
Date data sharing statement initially provided
8/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of time restricted eating compared to diet modification in people with type 2 diabetes
Scientific title
A randomised controlled trial to compare time restricted eating with standard dietetic practices on glycaemic control in individuals with type 2 diabetes: a pilot study
Secondary ID [1] 300202 0
None
Universal Trial Number (UTN)
U1111-1246-5605
Trial acronym
DIETRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 315758 0
Overweight/Obesity 315759 0
Condition category
Condition code
Metabolic and Endocrine 314038 314038 0 0
Diabetes
Diet and Nutrition 314039 314039 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomly allocated to the time-restricted eating group (TRE) will be asked to follow a time-restricted eating pattern (TRE) where they will be asked to reduce their energy intake to 9 hours (finishing eating no later than 7:30 pm) on as many days of the week as possible for the duration of the 6-month intervention. Participants will attend four x 30-45-minute consults, similar to general practitioner (GP) or dietitian check-ups, with the study dietitian who will provide advice regarding strategies to adhere to the altered timing of eating only. Consults will be scheduled for the beginning of the intervention, and after 1, 2 and 4 months of the intervention.

During pre-determined monitoring periods, participants will record their dietary intake using the Easy Diet Diary app, or standard written food diaries, and will take photos with their smart phone to capture the time that they have eaten their meals (especially the first and last eating occasion; i.e. anything from dinner onward will be photographed).

Adherence will be measured through calculating the total eating duration over each weekday and weekend day, with participants encouraged to adhere to the 9-hour limit (e.g. 9 am to 6:30 pm or 10:30 am to 7:30 pm) on as many days of the week as possible.
Intervention code [1] 316475 0
Lifestyle
Comparator / control treatment
Participants randomly allocated to the diet modification group (DIET) will be asked to implement current diabetes standard practice guidelines; namely, Section 6.2 of the 2018 RACGP Guidelines for General Practice Management of Type 2 diabetes, which in addition to the Australian Dietary Guidelines incorporate information regarding eating for cardiovascular protection and glycaemic management and meal planning, in conjunction with ‘Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report’ published by the American Diabetes Association in 2019.

Participants will attend consults with the study dietitian, similar to GP or dietitian check-ups, who will provide advice tailored to the individual regarding diet modification from improving blood glucose control.

During predetermined monitoring periods, participants will record their dietary intake using the Easy Diet Diary app, or standard written food diaries, and will take photos with their smart phone to capture the time that they have eaten their meals (especially the first and last eating occasion; i.e. anything from dinner onward will be photographed).
Control group
Active

Outcomes
Primary outcome [1] 322456 0
As a clinically-relevant measure of improved glycemic control, HbA1c (%) will be measured from whole blood in both groups.
Timepoint [1] 322456 0
HbA1c (%) will be measured every two months (baseline, 2 months, 4 months and 6 months) with the primary comparison being the change measured between baseline and 6 months.
Secondary outcome [1] 378597 0
An exploratory measure of glucose control (via a composite measure of daily mean, daily AUC, time spent in hypoglycemia (<3.8 mmol/L), time spent in hyperglycemia (>10 mmol/L) etc.) will be measured using continuous glucose monitors worn through five x 2-week periods during the 6 month intervention period.
Timepoint [1] 378597 0
All participants will wear continuous glucose monitors during the 2-week habitual period, and two weeks of the first, second, forth and sixth month of the intervention.
Secondary outcome [2] 378822 0
Adherence to dietary recommendations. For both groups, this will be assessed by a self-reported rating of adherence via a Likert scale.
Timepoint [2] 378822 0
Self-reported ratings will be collected after 1,2,4 and 6 months of the intervention.
Secondary outcome [3] 378823 0
As an exploratory outcome, we will assess several measures of psychological well-being including depression, anxiety and stress (using DASS), quality of life (AQOL-8D), sleep quality (using PSQ), behaviour and attitude towards eating (using EDE-Q) and psychosocial impairment resulting from eating disorder symptoms (CIA).
Timepoint [3] 378823 0
Self-reported questionnaires implemented at baseline, 2, 4 and 6 months will be scored and assessed
Secondary outcome [4] 378889 0
As an exploratory, secondary outcome we will explore the plasma glucose and insulin concentrations (as total area under the curves (AUC)) as measured in response to a 2-h mixed-meal tolerance test (MMTT).
Timepoint [4] 378889 0
MMTTs will be completed at the end of the 2-week habitual period, 2-months into the intervention period and at the end of the 6-month intervention.
Secondary outcome [5] 379340 0
Activity patterns, assessed using ActivPAL
Timepoint [5] 379340 0
Measured during two week periods, as per glucose monitoring (i.e. during the 2-week habitual period, and two weeks of the first, second, forth and sixth month of the intervention).
Secondary outcome [6] 379341 0
Participant responses to qualitative interview to understand barriers and enablers of adherence to either dietary regime via in-person interviews that are voice recorded, transcribed and analysed for themes.
Timepoint [6] 379341 0
Assessed 2, 4 and 6 months from the start of the intervention period.

Eligibility
Key inclusion criteria
• Aged 35 to 65 years old
• Diagnosed (by a GP/endocrinologist) with type 2 diabetes mellitus (T2D), with an HbA1c between 6.5% - 10%, either with diet-controlled or taking up to two oral hypoglycaemic agents (excluding sulphonylureas)
• Body mass index (BMI) between 25 - 45 kg/m2 (but total mass not >200 kg due to DXA measures)
• Currently consuming energy (i.e. dietary intake) over a period of 12 h or more, habitually (i.e. self-reported on 5/7 days per week)
Minimum age
35 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Does not have a smart phone or cannot operate the camera function on a smart phone;
• Taking more than 2 oral hypoglycaemic agents (OHAs), taking sulphonylrueas, or other glucose lowering medications (i.e. GLP-1 angonists, or insulin), or unstable use of OHA (i.e. not taking them for at least a 3 month period).
• Currently following a strict diet (i.e. vegan, coeliac/gluten free, ketogenic);
• Participate in regular fasting (defined as fasting for greater than or equal to 16 h/day or having completed twelve 24-h fasts within the past year);
• Participating in shift work (i.e. >3 h between 10 pm and 5 am for 1 day per week (>50 days per year))
• Not weight stable (>5 kg change over last 3 months);
• On prescribed medications required to be taken with food in the early morning or late evening or taking other prescribed medications for <3 months;
• Current smoker (tobacco, nicotine or marijuana) or within 3 months of quitting;
• Women who are pregnant, breastfeeding (within 24 wk);
• History of psychotic disorder, current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder; does not include depression)
• Psychopharmacological treatment that has not been stable for more than 3 months;
• Medications known to promote weight gain, weight loss or interact with glucose metabolism (i.e. corticosteroids);
• Diagnosed gastrointestinal conditions, surgery (i.e. bariatric) or impaired nutrient absorption.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed as randomisation of participants into DIET or TRE will occur after obtaining informed consent using automated procedures integrated into the trial management software. Participants will be informed of their allocation following completion of the 2-week habitual period and start of the intervention (Visit 2).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation using a randomisation table created by computer software (i.e. computerised sequence generation), in block sizes of 4-8.
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
Both intention to treat (ITT) and per protocol (PP) analyses will be conducted to establish the magnitude of change that TRE and DIET have on HbA1c (%) between 0 and 6 months. Linear mixed models with covariates of baseline HbA1c and sex will be used to compare changes in HbA1c between conditions.

Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment postcode(s) [1] 28969 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 304633 0
Charities/Societies/Foundations
Name [1] 304633 0
Diabetes Australia
Address [1] 304633 0
Level 1, 101 Northbourne Ave, Turner ACT 2612
Country [1] 304633 0
Australia
Primary sponsor type
Individual
Name
Dr Evelyn Parr
Address
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne 3000 VIC
Country
Australia
Secondary sponsor category [1] 304930 0
None
Name [1] 304930 0
Address [1] 304930 0
Country [1] 304930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305053 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 305053 0
Manager, Ethics
c/o Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059
Ethics committee country [1] 305053 0
Australia
Date submitted for ethics approval [1] 305053 0
21/11/2019
Approval date [1] 305053 0
09/03/2020
Ethics approval number [1] 305053 0
2019-359HC

Summary
Brief summary
The proposed study will be the first to compare the benefits of TRE for improving glycaemic control compared with standard dietetic advice, in individuals with T2D in a chronic (6 months) randomised controlled trial. Evidence-based findings for the improvement of blood glucose control and longer term outcomes need to be developed in order for this information to be available for the design of larger studies, prior to being incorporated into current dietary guidelines and inform best practice. The combination of physiological and psychosocial measures will allow us to demonstrate the efficacy and safety of using TRE in a real-world setting to reduce the psychological burden of dietary modifications, whilst improving glycaemic control, for individuals with type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99110 0
Dr Evelyn Parr
Address 99110 0
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne 3000 VIC
Country 99110 0
Australia
Phone 99110 0
+61 3 92308278
Fax 99110 0
Email 99110 0
evelyn.parr@acu.edu.au
Contact person for public queries
Name 99111 0
Miss Bridget Radford
Address 99111 0
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne 3000 VIC
Country 99111 0
Australia
Phone 99111 0
+61 3 9230 8284
Fax 99111 0
Email 99111 0
bridget.radford@acu.edu.au
Contact person for scientific queries
Name 99112 0
Dr Evelyn Parr
Address 99112 0
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne 3000 VIC
Country 99112 0
Australia
Phone 99112 0
+61 3 92308278
Fax 99112 0
Email 99112 0
evelyn.parr@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Potentially identifiable information
What supporting documents are/will be available?
No other documents available
Summary results
No Results