Young women and weight loss study 2007
A 48 week trial comparing the Effect of Metformin or Internet-based Lifestyle Program Compared to Placebo on Obesity Management in Young Women.
Commonwealth Scientific Industrial Research Organisation, Human Nutrition
300 participants
Mar 19, 2007
Interventional
Conditions
Summary
The aim of this study is to compare the effectiveness of an internet-based lifestyle modification (high protein diet) program, tailored for overweight/obese young women (age 18 to 35 years), against metformin or placebo treatments in achieving and maintaining weight loss. We also want to assess the effects of different methods of weight loss on reproductive function, metabolic health, and nutritional status. Information on psychological well-being and general health will also be collected.
Eligibility
Inclusion Criteria1
- Overweight or obese (Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2) • Available for the duration of the study (1 year)• Generally healthy with no chronic or acute diseases or disorders on medical history as outlined in the medical screening questionnaire (eg life-threatening cancer, liver disease, kidney disease)• Willing to be randomised to any experimental group• Have access to internet• Able to swallow whole tablets (up to three a day).
Exclusion Criteria1
- Known cardiovascular disease, Type 1 or Type 2 diabetes, uncontrolled hypertension, a malignancy, a history of liver, kidney or respiratory disease.• Known thyroid abnormalities (hypo- and hyperthyroidism).• Being treated for eating disorders. • Receiving fertility treatment such as clomiphene citrate, gonadotrophins, In Vitro Fertilisation (IVF), or insulin-sensitising agents • Currently experiencing rapid weight loss.• Has known adverse reaction toward metformin.• Has a history of heavy alcohol consumption (>5 standard drinks/day) and unable to cease.• Pregnant or breastfeeding.
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Interventions
There are 3 treatment groups in the first 12 weeks of weight loss intervention: 1) Metformin (1500mg Diabex XR oral tablet daily) 3) Internet-based lifestyle program In the following 36 weeks of weight maintenance, all participants will be placed on the lifestyle program (as described). The Internet-based lifestyle program will include a high protein diet (30% protein,40% carbohydrate, 30% fat), aerobic and resistance exercise, online support (diet information, exercise information, lifestyle counselling).
Locations(1)
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ACTRN12607000213448