None listed
Conditions
Brief 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.
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, lifestyl
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).
Sponsors
Commonwealth Scientific Industrial Research Organisation, Human Nutrition
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed