What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
- •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)
研究组 & 干预措施
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.
干预措施: Time-restricted eating (Other)
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).
干预措施: Current Best Practice (Other)
结局指标
主要结局
HbA1c
时间窗: baseline, 4 months
Glycated haemoglobin concentration
次要结局
- HOMA-IR(baseline, 4 months, 12 months)
- Fasting blood glucose(baseline, 4 months, 12 months)
- Nocturnal glucose(baseline, 4 months)
- HbA1c(12 months)
- Fasting insulin(baseline, 4 months, 12 months)
研究者
A/Prof Leonie Heilbronn
Group Leader, Obesity and Metabolism
University of Adelaide