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

NCT04762251 | Completed DMC

• 1 other identifier: 14023
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Time-restricted Eating; Diet Quality

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Glycated haemoglobin concentration

  baseline, 4 months

Secondary Outcomes (5)

• HbA1c

  12 months

• Fasting blood glucose

  baseline, 4 months, 12 months

• Fasting insulin

  baseline, 4 months, 12 months

• HOMA-IR

  baseline, 4 months, 12 months

• Nocturnal glucose

  baseline, 4 months

Other Outcomes (21)

• Per protocol analysis

  4 months, 12 months

• Body weight

  baseline, 4 months, 12 months

• Body composition

  baseline, 4 months, 12 months

Study Arms (2)

Time-restricted eating (TRE)

EXPERIMENTAL

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

Current Best Practice (CP)

ACTIVE COMPARATOR

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

Interventions

Time-restricted eating OTHER

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

Time-restricted eating (TRE)

Current Best Practice OTHER

Best practice guidelines to improve diet quality

Current Best Practice (CP)

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \[i.e. 'gliptins'\])

Sponsors & Collaborators

• University of Adelaide: lead
• Australian Catholic University: collaborator
• La Trobe University: collaborator

Study Sites (2)

South Australian Health and Medical Research Institute

Adelaide, South Australia, Australia

Location

Mary Mackillop Institute for Health Research

Melbourne, Victoria, Australia

Location

Related Publications (1)

• Charrouf R, Parr EB, Hutchison AT, Flint SA, Teong XT, Wittert G, Vincent AD, Brennan L, Devlin BL, Hawley JA, Heilbronn LK. Effect of time restricted eating versus current practice in dietetics on glycaemic control and cardio-metabolic outcomes in individuals at risk of developing type 2 diabetes: Protocol for a multi-centre, parallel group, non-inferiority, randomised controlled trial. Contemp Clin Trials. 2024 Nov;146:107696. doi: 10.1016/j.cct.2024.107696. Epub 2024 Sep 17.

  PMID: 39299545 DERIVED

Related Links

• preprint of the study protocol

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Leonie Heilbronn, PhD

  University of Adelaide

  PRINCIPAL INVESTIGATOR

• John Hawley, PhD

  Australian Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group Leader, Obesity and Metabolism

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: February 17, 2021
• Primary Completion: August 2, 2023
• Study Completion: April 19, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 36 months from date of publication
• 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.

Locations

AU (2)