What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)

July 31, 2024 updated by: A/Prof Leonie Heilbronn, University of Adelaide
A parallel, single-blinded, multi-centre randomized controlled trial conducted at the South Australian Health and Medical Research Institute (SAHMRI) and the Mary Mackillop Institute for Health Research (MMIHR; Australian Catholic University), by researchers from the University of Adelaide, Australian Catholic University and La Trobe University.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In a parallel groups design, a total of 268 individuals will be recruited across both sites. After a 2-week baseline period, and a baseline metabolic visit, participants will be randomized into one of two groups (TRE, time-restricted eating; CP, current practice guidelines). All participants will receive five (5) telehealth consultations at baseline, week 2, 4, 8 and 12, the content of which will be based around their randomized condition. They will undergo metabolic testing on two (2) further occasions (4 months, 12 months) over a 12-month period to assess the changes in primary and secondary outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
247

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
        • South Australian Health and Medical Research Institute
    • Victoria
      • Melbourne, Victoria, Australia
        • Mary Mackillop Institute for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Time-restricted eating
Time restricted eating for a self-selected 9 hour window per day
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: Current Best Practice
Best practice guidelines to improve diet quality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: baseline, 4 months
Glycated haemoglobin concentration
baseline, 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 12 months
Glycated haemoglobin concentration
12 months
Fasting blood glucose
Time Frame: baseline, 4 months, 12 months
fasting blood glucose concentrations
baseline, 4 months, 12 months
Fasting insulin
Time Frame: baseline, 4 months, 12 months
fasting insulin concentrations
baseline, 4 months, 12 months
HOMA-IR
Time Frame: baseline, 4 months, 12 months
HOMA-IR
baseline, 4 months, 12 months
Nocturnal glucose
Time Frame: baseline, 4 months
AUC of glucose assessed by CGM from midnight to 0400
baseline, 4 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Per protocol analysis
Time Frame: 4 months, 12 months
Per protocol analysis of data from participants who self-report adherence as 5-6 days per week or every day at 3.5 and 4 month adherence questionnaires ("adherent to the protocol")
4 months, 12 months
Body weight
Time Frame: baseline, 4 months, 12 months
body weight (assessed after an overnight fast, in a hospital gown)
baseline, 4 months, 12 months
Body composition
Time Frame: baseline, 4 months, 12 months
components of body composition assessed by DXA: fat mass (as percent body fat and kg), fat free mass (FFM, kg), visceral adipose tissue (VAT, g) and bone mass (kg)
baseline, 4 months, 12 months
Waist circumference
Time Frame: baseline, 4 months, 12 months
waist circumference (cm)
baseline, 4 months, 12 months
Hip circumference
Time Frame: baseline, 4 months, 12 months
hip circumference (cm)
baseline, 4 months, 12 months
Blood lipids
Time Frame: baseline, 4 months, 12 months
total, HDL and LDL cholesterol and triglycerides
baseline, 4 months, 12 months
hs-CRP
Time Frame: baseline, 4 months, 12 months
high sensitivity C-reactive protein (hs-CRP)
baseline, 4 months, 12 months
Liver markers
Time Frame: baseline, 4 months, 12 months
alanine transaminase (ALT) and aspartate aminotransferase (AST)
baseline, 4 months, 12 months
24h assessment of glycaemia
Time Frame: baseline, 4 months
24h glucose measures assessed by CGM (including, but not limited to, time in range, CV)
baseline, 4 months
Physical activity
Time Frame: baseline, 4 months, 12 months
Components of activity (Step count, time in bed) assessed by inclinometer
baseline, 4 months, 12 months
Sleep duration
Time Frame: baseline, 4 months, 12 months
Sleep duration calculated from self-reported sleep/wake times
baseline, 4 months, 12 months
Cardiovascular measures
Time Frame: baseline, 4 months, 12 months
blood pressure and heart rate assessed using automated sphygmomanometer
baseline, 4 months, 12 months
meal timing / eating window
Time Frame: baseline, 4 months, 12 months
duration of eating window and individual meal times calculated from time-stamped food photos and/or self-reported meal times
baseline, 4 months, 12 months
Dietary intake
Time Frame: baseline, 4 months, 12 months
energy and macronutrient composition calculated from food diaries (research food diary app)
baseline, 4 months, 12 months
Adherence
Time Frame: 3.5, 4, 11.5, 12 months
measures of adherence assessed by self-report (questionnaire)
3.5, 4, 11.5, 12 months
Chronotype
Time Frame: baseline, 3.5, 4, 11.5, 12 months
participant chronotype calculated from MEQ-SA questionnaire
baseline, 3.5, 4, 11.5, 12 months
TRE vs CP on ambulatory blood pressure and renal function (sub-study)
Time Frame: baseline, 4 months
Day and night time blood pressure (systolic, diastolic), dipping, morning surge, heart rate, blood pressure and heart rate variability. mesor, phase and amplitude of 24 hour ambulatory blood pressure monitoring; change in eGFR, creatinine, albumin urinary albumin:creatinine ratio, blood urea nitrogen and C-RP
baseline, 4 months
TRE vs CP on CGM outcomes in a subset of individuals with pre-diabetes (sub-study)
Time Frame: 4 months, 12 months
Change in CGM metrics (including 2 hour at-home glucose challenge) in participants with HbA1c >5.7% at baseline
4 months, 12 months
TRE vs CP on quality of life, mood, sleep and food preferences (sub-study)
Time Frame: 4 months, 12 months
Assessment of lifestyle using AQOL, mood using DASS-21 and CIA, sleep using PSQI and food preferences using NQOL and DRQOL
4 months, 12 months
TRE vs CP on diet quality (sub-study)
Time Frame: 4 months, 12 months
Assessment of changes in diet quality in TRE vs CP groups over 12 months using HEIFA (Healthy eating index for Australian Adults)
4 months, 12 months
TRE vs CP on barriers and enablers of adherence (sub-study)
Time Frame: 4 months, 12 months
Qualitative interview of a subset of participants to identify barriers and enablers of adherence to TRE vs CP advice
4 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Adelaide

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Australian Catholic University
La Trobe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Hawley, PhD, Australian Catholic University
  • Principal Investigator: Leonie Heilbronn, PhD, University of Adelaide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14023 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

36 months from date of publication

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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