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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)

Not Applicable
Active, not recruiting
Conditions
obesity
overweight
cardiovascular disease
osteoporosis
sarcopenia
binge eating
mood disorders
Diet and Nutrition - Obesity
Diet and Nutrition - Other diet and nutrition disorders
Cardiovascular - Coronary heart disease
Registration Number
ACTRN12623000338662
Lead Sponsor
The University of Western Australia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
304
Inclusion Criteria

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

Exclusion Criteria

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

Porphyria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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