ACTRN12623000338662进行中（未招募）Unknown
Comparison of two weight loss programs involving 16 weeks on a severely energy-restricted diet in adults with overweight or obesity: The TANGO Diet Trial (Temporary phases of Accelerated weight loss for Noticeably Greater Outcomes)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 304
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •18-70 years of age
- •Body mass index (BMI) equal to or greater than 30 kg/m2 or BMI equal to or greater than 27 kg/m2 if disease risk factors and/or obesity-related comorbidities are present
- •Able to attend our facility 17 times over the 104-week (24-month) clinical trial (15 times in the first 53 weeks (12 months)
- •Weight stable for at least 1 month (± 2 kg) before commencement of the severe diet
- •Living in the Perth metropolitan area
- •Able to understand written and spoken English
- •Have access to an email account
- •Have access to a computer (either a smartphone, laptop or desktop) and the Internet
排除标准
- •Type 1 diabetes
- •Pregnancy (or breastfeeding)
- •Pregnancy planned in the next 2 years
- •Schizophrenia
- •Diagnosed eating disorder
- •A score on the Alcohol Use Disorders Identification Test – Consumption (AUDIT-C) of equal to or greater than 6 (for female adults) or equal to or greater than 7 (for male adults)
- •Unwillingness to abstain from the consumption of alcohol during the 16-week severe diet
- •Use within the past 6 months of any illegal or recreational drugs
- •Severe/advanced kidney disease
- •Severe/advanced liver disease
- •Recent myocardial infarction (3 months)
- •Recent cerebrovascular event (3 months)
- •Recent commencement of anticoagulant (e.g., warfarin) treatment (3 months)
- •Current fluid restriction treatment
- •Unstable angina
- •Lactose intolerance
- •Strict veganism
- •Unwillingness to consume the meal replacement products to be provided by the research trial for 16 weeks
- •Previous bariatric surgery
- •Bariatric surgery planned in the next 2 years
- •Recent involvement in another clinical trial (3 months)
- •Involvement in another clinical trial planned in the next 2 years
- •Tobacco or vape use in the past 6 months
研究者
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