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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04762251




Registration number
NCT04762251
Ethics application status
Date submitted
16/02/2021
Date registered
21/02/2021

Titles & IDs
Public title
What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)
Scientific title
What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)
Secondary ID [1] 0 0
14023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Time-restricted Eating 0 0
Diet Quality 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Time-restricted eating
Other interventions - Current Best Practice

Experimental: Time-restricted eating (TRE) - The TRE group will be instructed to follow TRE (9 h/day) every day for 12 months with no other dietary instructions or advice provided. The TRE group will attend the same consult schedule as the CP group, but consultations will focus on timing of dietary intake and strategies to promote adherence. No dietary guidance regarding quantity or quality will be provided. Participants will be able to self-select the precise 9-h schedule that will best suit their lifestyles, with the caveat that the latest time of eating will be set at 7:00 pm. Outside of the elected eating window, participants will be allowed to consume water and black coffee and/or tea.

Active comparator: Current Best Practice (CP) - This group is designed to act as a comparator using 'standard care' in dietetics practice. Dietary advice provided to this participant group will be performed by Accredited Practicing Dietitians (APDs) in line with evidence-based guidelines, specifically the T2DM best-practice guidelines plus Australian Dietary Guidelines (i.e. Australian Guide to Healthy Eating) to improve diet quality, and strategies to promote adherence. No specific advice will be provided regarding time of day to start and finish eating and/or drinking (since this information is not outlined in current practice guidelines).


Other interventions: Time-restricted eating
Time restricted eating for a self-selected 9 hour window per day

Other interventions: Current Best Practice
Best practice guidelines to improve diet quality
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
baseline, 4 months
Secondary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Fasting blood glucose
Timepoint [2] 0 0
baseline, 4 months, 12 months
Secondary outcome [3] 0 0
Fasting insulin
Timepoint [3] 0 0
baseline, 4 months, 12 months
Secondary outcome [4] 0 0
HOMA-IR
Timepoint [4] 0 0
baseline, 4 months, 12 months
Secondary outcome [5] 0 0
Nocturnal glucose
Timepoint [5] 0 0
baseline, 4 months

Eligibility
Key inclusion criteria
* Study participants will be aged 35 to 70 years, overweight or obese (BMI: >25 but <45 kg/m2), =15 on the AUSDRISK assessment tool and have HbA1c <6.5% at screening
Minimum age
35 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Type 1 or type 2 diabetes, or diabetes detected at screening HbA1c =6.5% (48 mmol/mol).

* A personal history/diagnosis (self-reported) of:

* major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders)
* gastrointestinal disorders/disease (including malabsorption)
* haematological disorders (i.e. thalassemia, iron-deficiency anaemia)
* insomnia
* currently receiving, or have received treatment/diagnosis of cancer in the past 3 years (excluding non-melanoma skin cancer)
* significant liver or kidney disease
* previous or planned gastro-intestinal surgery (including bariatric surgery)
* Congestive heart failure (NYHA stage 2 or above)
* Previous myocardial infarction or significant cardiac event = 6 months prior to screening
* Previous cerebrovascular event = 12 months prior to screening

and/or any other condition deemed unstable by the study physician.

Currently taking the following medications:

* any medication used, or known to lower blood glucose, or antidiabetic medications, including, but not limited to: SGLT2 inhibitors, metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins'])
* Medications affecting weight, appetite or gut motility, including, but not limited to: (domperidone, cisapride, orlistat, phentermine, topiramate).
* Diuretics (i.e. frusemide, thiazides) or combination blood pressure medications containing a diuretic
* Beta-blockers
* Glucocorticoids
* Anti-epileptic medications
* Antipsychotic medications
* Opioid medications unless combined with paracetamol in a single formulation and used occasionally on a PRN basis

Additional exclusion criteria include:

* do not consume a regular breakfast (i.e. eat breakfast on an average of 5 or more days per week), and do not eat for more than 12 hours per day on an average of 5 or more days per week
* have an extreme or restricted pattern of eating (i.e. following an intermittent fasting diet) or are already engaged in a TRE protocol
* shift-workers
* pregnant, planning a pregnancy or currently breastfeeding
* those who have lost or gained >5% of body weight in the last 6 months
* current smokers of cigarettes/marijuana/e-cigarettes/vaporisers
* anyone unable to comprehend the study protocol or provide informed consent (i.e. due to English language or cognitive difficulties)
* Participants will not have seen a dietitian in the preceding 3 months.
* score on K10 =30 (Kessler Psychological Distress scale)
* score on EDEQ =2.8 (Eating Disorder Examination Questionnaire)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/04/2024
Sample size
Target
Accrual to date
Final
247
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
South Australian Health and Medical Research Institute - Adelaide
Recruitment hospital [2] 0 0
Mary Mackillop Institute for Health Research - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Catholic University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
La Trobe University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Hutchison, PhD
Address 0 0
Country 0 0
Phone 0 0
08 8128 4862
Fax 0 0
Email 0 0
amy.hutchison@adelaide.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data that support the findings of this study will be available from the corresponding author for a period of 36 months from publication, upon reasonable request for academic use. The data will not be made publically available, as it contains information that could compromise research participant consent.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
36 months from date of publication
Available to whom?
Reasonable requests of data for academic use will be considered. Requests can be made to the corresponding author of the publication. Data will not be made publically available as it contains information that could compromise research participant consent.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

TypeOther DetailsAttachment
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/51/NCT04762251/SAP_000.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04762251