Clinical Trials being conducted at The Boden Institute

Currently recruiting participants

Fully recruited trials


CURRENTLY RECRUITING

HAPIFED Weight Management and Eating Disorder Program

The Universities of Sydney and Western Sydney are conducting a free program for individuals 18 years or older who are overweight and who have a problem with binge eating or bulimia. The program aims to determine which of two treatments may be most effective at helping people to reduced disordered eating and at the same time improve weight management, so that they can lose weight and then maintain this weight loss over the longer-term. The program involves 19 skills-based group treatment sessions over 2 months.

Please contact:
Phone: 02 9351 5428
Email: or
For general enquiries please contact Claire McAulay on 02 9036 3442.

The PREVIEW Study Australia: Prevention of diabetes through lifestyle intervention

Are you overweight? Do you lose weight but have trouble keeping it off?
If so, you could have ‘pre-diabetes’.

Professor Jennie Brand-Miller from the University of Sydney is looking for volunteers to take part in a free weight loss and weight maintenance program to help reduce the risk of developing type 2 diabetes.

This international study provides help from dietitians and your medical progress is fully monitored for 3 years. This is a new approach to weight control without the use of medications.

If you are between the ages of 25 and 70 and would like to be considered…
Call or SMS 0434 751 015
Or email:
Or visit http://www.preview.ning.com/sydney
For general enquiries please contact Ros Muirhead on 02 9036 3024.

Exercise and liver fat reduction in pre-diabetes: moving beyond weight loss

A fatty liver contributes to the risk of cardiovascular and metabolic disease (including diabetes) and is often seen in people who are overweight. Recent scientific studies have shown that exercise can lower liver fat with or without weight loss. However, there are currently no guidelines for exercise to manage liver fat levels.

This research aims to examine the components of regular exercise which result in a liver benefit by comparing different aerobic and resistance exercise programs on liver fat and cardiovascular risk outcomes. To be a participant in this trial you need to be aged between 29-59, have a body mass index (BMI) greater than 25 and not currently be undertaking regular exercise.

Now recruiting for a September intake.

Contact: Shelley Keating on 0405 735 200 or

The TEMPO Diet Trial: Type of Energy Manipulation for Promoting optimum metabolic health and body composition in Obesity

DXA body scan

Participants will receive a free weight loss program for 12 months, as well as regular body composition assessments to demonstrate their % of body fat, lean mass, and bone mineral density

For many years health professionals have recommended ‘slow and steady’ weight losses of approximately 0.1 to 1 kilo per week. In recent years however, an increasing number of health professionals are prescribing meal replacement diets called very low calorie diets (VLCDs) because they can induce relatively fast weight losses of approximately 0.5 to 2 kilos per week, which some people find motivating, and because some people report not feeling hungry while following a VLCD.

While VLCDs are known to be safe and effective in the short-term (for up to one year), the long-term consequences are unknown. This study will demonstrate whether or not there is any difference between the effects of weight loss via VLCD or conventional diet on metabolic health, body fat content and distribution, muscle mass and strength, and bone density in post-menopausal women for 3 years after commencement of the diet.

To watch Associate Professor Amanda Salis talking about the TEMPO Diet Trial click here.

To read the Information for Participants click here (PDF file).

Recruitment for the TEMPO Diet Trial is currently underway. If you are interested in participating in this trial and are female, living in the Sydney metropolitan area, aged 45-65, postmenopausal for 5 years or more, are non-diabetic and you have a body mass index (BMI*) of 30 to 40 kg/m2, you may be eligible for this study.

*To calculate your BMI, divide your weight in kilograms by the square of your height in meters, or use this web-based BMI calculator: http://www.heartfoundation.org.au/healthy-eating/Pages/bmi-calculator.aspx.

Contact: Dr Radhika Seimon on 9036 3445 / or Associate Professor Amanda Salis on

For more information about Associate Professor Amanda Salis' research, please visit her Sydney Medical School research profile at http://sydney.edu.au/medicine/people/academics/profiles/asalis.php


FULLY RECRUITED

EXSCEL Clinical Trial

James Gerofi and Mackenzie Fong from the Boden Institute

James Gerofi and Mackenzie Fong at the Boden Institute

** Please note: participants have now been fully recruited for this trial ** Type 2 diabetes is a leading public health issue. The majority of people with type 2 diabetes die as a result of cardiovascular disease (CVD). A number of trials in people with Type 2 diabetes have shown their CVD risk can be reduced by lowering cholesterol, blood pressure and glycated haemoglobin or all 3 risk factors.

The EXSCEL Trial is looking at a medication called Exenatide in reducing the above risk factors and promoting weight loss. Participants must have Type 2 diabetes and a history of cardiovascular disease. The medication is self injected once weekly and participants will be enrolled in the trial between 4-7 years. Appointments at the Institute are twice a year. Participants meet with our expert staff consisting of Endocrinologists, Nurses, Dietitians and Exercise Physiologists to manage their health care throughout the trial.

Contact: James Gerofi on 9036 3459 or

Cognitive behavioural therapy and electronic support for weight loss among obese patients: A randomised controlled trial

Picture of a mobile phone

** Please note: participants have now been fully recruited for this trial ** As lifestyle decisions made continuously throughout each day determine an individual’s overall level of weight loss success, this study aims to assess the effectiveness of Cognitive Behavioural Therapy (CBT) combined with Electronic Support for improving weight loss among obese adults. CBT assists individuals to identify and overcome unhelpful thinking patterns that lead to problematic behaviours (such as emotional eating that results in excessive calorie intake and insufficient physical activity), thereby enabling them to make difficult long-term lifestyle changes that lead to sustained weight loss. In addition, novel modes of providing support to obese individuals are increasingly being adopted, with technology-based approaches (e.g., web-based treatment, e-mail contact etc) being used to improve participant engagement, monitor healthy behaviours, and maintain treatment gains.

The present study augments CBT treatment with daily electronic communication (in the form of daily text-messages and e-mail communication) so as to enhance the intensity of support provided to obese adults during the weight loss phase. The combined use of CBT and electronic support aims to provide individuals with the tools as well as the support required to successfully change their eating and physical activity patterns.

Participants in this trial are aged between 18 and 65 years, have a body mass index (BMI) of 30 or above and are not currently undertaking any treatment for weight loss.

Contact: Claire McAulay on 9036 3442 or

Are eggs good for people with type 2 diabetes?

Eggs

** Please note: participants have now been fully recruited for this trial ** This study investigates the role of eggs in the dietary management of type 2 diabetics. Eggs contain a number of important nutrients that may reduce the risk of cardiovascular disease including folate, long chain omega 3 fatty acids, and arginine. They have also been shown to improve our good cholesterol (high density lipoprotein-cholesterol – HDL-C). Improvements in HDL-C are known to reduce cardiovascular risk. Eggs are a nutrient-dense food that are not high in energy. Despite being rich in cholesterol, the amount of total fat and saturated fat in eggs is not high and the fat in eggs is predominantly unsaturated (44% monounsaturated; 11% polyunsaturated). The theoretical increase in cardiac risk from the cholesterol contained in eggs is likely to be minimal when compared to other cardiovascular risk factors including saturated fat intake, lack of physical activity, smoking, hypertension and obesity.

In this study we aim to identify the potential health benefits of a high egg diet in pre-diabetics and those with type 2 diabetes. Participants must be pre-diabetic or have type 2 diabetes, have a BMI greater than 25, and be able to follow a specific high egg diet (2 or more eggs/day for 6 days per week) or a low egg diet (less than 2 eggs per week). Participants are required to attend the Boden Institute for a total of 11 visits over 12 months, and will meet with our expert staff consisting of Endocrinologists, Nurses, Dietitians and Exercise Physiologists in managing their health care throughout the trial.

Contact: Nick Fuller on 9036 3468 or

A novel exercise regime to reduce cardiometabolic risk in overweight sedentary individuals

** Please note: participants have now been fully recruited for this trial ** Regular exercise produces many health and fitness benefits, but the effectiveness of different types of exercise programs is unclear. Current health recommendations for people who are overweight suggest that exercise should be regular, low intensity and prolonged. However there is new evidence that exercise involving either short high intensity bursts of strenuous exercise with regular recovery periods, or stretching/massage and core stability work may produce these benefits in less time.

The aim of this research is to compare the benefits of different types of exercise programs. To be a participant in this trial you need to be aged between 18-55, have a body mass index (BMI) between 25 and 29.9 and not currently be undertaking regular exercise.

Contact: Shelley Keating on 0405 735 200 or

The effectiveness of motivational enhancement therapy for obese patients and support partners in weight maintenance: A randomised controlled trial

Clare Manns demonstrating to a group

Dr Clare Manns demonstrates the practice of motivational enhancement strategies to support people at the Boden Institute

** Please note: participants have now been fully recruited for this trial ** The critical challenge for all obesity treatments is improving the maintenance of weight loss. As one of the most common barriers to successful weight management reported by individuals is “staying motivated”, this study aims to assess the effectiveness of Motivation Enhancement Therapy (MET) combined with a behavioural weight loss approach (BWL) for improving weight loss maintenance. MET aims to increase participant’s self-motivation to change problematic behaviours (such as excessive calorie intake and insufficient physical activity), thereby enabling them to make difficult long-term lifestyle changes that lead to sustained weight loss.

Combining MET and BWL treatment frameworks is designed to produce patients who are both highly motivated to change (MET) and have the tools to successfully change (BWL). The effectiveness of MET in this study will be augmented by instructing patient’s support partners in the practice of motivational enhancement strategies. Participants in this trial are between the ages of 18-70 years, have a body mass index (BMI) between 30-60 and are not currently undertaking any treatment for weight loss. Please note: recruitment for this trial has finished.

Contact: Jessica Swinbourne on 9036 3122 or

Gut Microbiota Trial

** Please note: participants have now been fully recruited for this trial ** This is a study of the role of microbiota in influencing the success of weight loss diets. Microbes influence how much energy we extract from our diet, how we regulate the storage of this as fat, and also on glucose regulation. There are both good and bad microbes. We have found that in overweight or obese persons undergoing weight loss diets, not everyone is successful and significantly those who fail to lose weight are also those who fail to change their microbial community composition.

In this study we aim to identify microbial signals in stool samples that will give successful weight loss outcomes and also to improve and change a person’s microbiota to a healthy composition. Participants must have a BMI between 25 and 35, be able to provide regular stool samples which will be collected in their home environment and brought in frozen for analysis of their gut microbiota, and follow a specific diet (high protein, low fat (low glycemic index), or a Mediterranean diet). Participants are required to attend the Boden Institute for a total of 10 visits over 12 months.

Contact: Nick Fuller on 9036 3468 or