None listed
Conditions
Brief summary
Amongst people undertaking any weight loss program, there is considerable variation in the amount of weight lost. Many studies have attempted to predict the outcome of weight loss treatments from information about biological, behavioural and psychological factors collected from participants before the start of treatment, but it has been difficult to predict outcomes using current methods. In a previous study conducted in our research group, we examined a statistical method which appeared to be useful in predicting the outcome of a medically supervised very-low-energy diet program using participants’ baseline physical measurements and psychological characteristics. However, further research is required in order to create a tool which will be useful to patients and healthcare providers. The overall aim of this study is to create a statistical model which can accurately predict the result for a person about to start a weight loss program.
Interventions
Participants will undertake an 8-week modified very-low-energy diet (VLED), in which 2 meals per day will be replaced with a commercially available very-low-energy diet formulation (Optifast VLCD milkshake or bar), along with a third meal consisting of lean protein and up to 2 cups of low-starch vegetables. At least 30 minutes per day of moderate intensity physical activity will be advised for all participants.
After a 2-week transition period in which participants will consume 1 meal replaceme
Participants will undertake an 8-week modified very-low-energy diet (VLED), in which 2 meals per day will be replaced with a commercially available very-low-energy diet formulation (Optifast VLCD milkshake or bar), along with a third meal consisting of lean protein and up to 2 cups of low-starch vegetables. At least 30 minutes per day of moderate intensity physical activity will be advised for all participants. After a 2-week transition period in which participants will consume 1 meal replacement and 2 meals, participants will cease the meal replacements and be instructed to follow a weight maintenance diet individualised for their energy requirements for weight maintenance for one year. Participants will be seen by a study physician or dietician every 2 weeks during the VLED phase, and every two months during the weight maintenance phase. At these visits, participants' weight, hip and waist circumferences will be measured, and dietary and exercise goals/advice will be reinforced. Beyond this, no specific strategies or tools will be used to improve or monitor adherence to the intervention protocols, in order to replicate a clinical setting as far as possible.
Sponsors
University of Melbourne, Department of Medicine (Austin Health)
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Weight stable for 3 months BMI greater than/equal to 30kg/m2 or BMI greater than/equal to 27kg/m2 with a medical condition related to excess weight BMI less than 60kg/m2
Exclusion criteria
Pregnancy or breast-feeding Previous surgery for weight loss The use of a VLED or weight-lowering medication in the past 3 months Change in weight of 3kg or more in the past 3 months Change in dosage of thyroid or other hormone replacement in past 3 months Planned surgery during the study Cessation of smoking in past 6 months Uncontrolled or clinically significant disease which would be a contraindication to a VLED Known alcohol or drug dependence in past 1 year
Outcome results
None listed