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

University of Adelaide

Status: Completed

Conditions: Time-restricted Eating; Diet Quality

Treatments: Other: Current Best Practice; Other: Time-restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT04762251

14023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 247 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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247 participants in 2 patient groups

Time-restricted eating (TRE)

Experimental group

Description:

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.

Treatment:

Other: Time-restricted eating

Current Best Practice (CP)

Active Comparator group

Description:

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).

Treatment:

Other: Current Best Practice