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

Last updated: July 31, 2024
Sponsor: University of Adelaide
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Time-restricted eating

Current Best Practice

Clinical Study ID

NCT04762251
14023
  • Ages 35-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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, bipolardisorder, 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 toscreening

  • 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 orDPP-IV inhibitors [i.e. 'gliptins'])

  • Medications affecting weight, appetite or gut motility, including, but not limitedto: (domperidone, cisapride, orlistat, phentermine, topiramate).

  • Diuretics (i.e. frusemide, thiazides) or combination blood pressure medicationscontaining a diuretic

  • Beta-blockers

  • Glucocorticoids

  • Anti-epileptic medications

  • Antipsychotic medications

  • Opioid medications unless combined with paracetamol in a single formulation and usedoccasionally on a PRN basis

Additional exclusion criteria include:

  • do not consume a regular breakfast (i.e. eat breakfast on an average of 5 or moredays per week), and do not eat for more than 12 hours per day on an average of 5 ormore days per week

  • have an extreme or restricted pattern of eating (i.e. following an intermittentfasting 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. dueto 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

Total Participants: 247
Treatment Group(s): 2
Primary Treatment: Time-restricted eating
Phase:
Study Start date:
February 17, 2021
Estimated Completion Date:
April 19, 2024

Study 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.

Connect with a study center

  • South Australian Health and Medical Research Institute

    Adelaide, South Australia
    Australia

    Site Not Available

  • Mary Mackillop Institute for Health Research

    Melbourne, Victoria
    Australia

    Site Not Available

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