RecruitingPhase 4ACTRN12607000213448

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.


Sponsor

Commonwealth Scientific Industrial Research Organisation, Human Nutrition

Enrollment

300 participants

Start Date

Mar 19, 2007

Study Type

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

Sex: FemalesMin Age: 18 YearssMax Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for young women who are overweight or obese and want to lose weight. It tests whether an internet-based lifestyle program using a high-protein diet works better than the medication metformin or a placebo (dummy pill) for achieving and maintaining weight loss over one year. The study also looks at the effects of weight loss on reproductive health, metabolism, and nutritional status. You may be eligible if: - You are female, between 18 and 35 years old - Your BMI is between 25 and 40 kg/m² - You are generally healthy with no major chronic diseases - You are available for the full 1 year of the study - You have access to the internet - You are willing to be assigned to any of the study groups You may NOT be eligible if: - You have heart disease, diabetes (type 1 or 2), uncontrolled high blood pressure, kidney disease, liver disease, or thyroid problems - You are being treated for an eating disorder - You are currently receiving fertility treatment - You are pregnant or breastfeeding - You have a history of heavy alcohol use - You have had a known bad reaction to metformin - You are currently losing weight rapidly Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12607000213448