Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000213448
Ethics application status
Approved
Date submitted
13/04/2007
Date registered
19/04/2007
Date last updated
19/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Young women and weight loss study 2007
Scientific title
A 48 week trial comparing the Effect of Metformin or Internet-based Lifestyle Program Compared to Placebo on Obesity Management in Young Women.
Secondary ID [1] 356 0
Commonwealth Scientific and Industrial Research Organisation: kv56a
Universal Trial Number (UTN)
Trial acronym
YW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity in young women 1740 0
Condition category
Condition code
Diet and Nutrition 1832 1832 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 1627 0
Lifestyle
Comparator / control treatment
2) Placebo oral tablets daily in the first 12 weeks of weight loss intervention.
Control group
Active

Outcomes
Primary outcome [1] 2563 0
Weight
Timepoint [1] 2563 0
At weeks 0, 12, 24 and 48
Primary outcome [2] 2564 0
Body composition
Timepoint [2] 2564 0
At weeks 0, 12
Secondary outcome [1] 4420 0
Fasting serum total cholesterol, triglyceride, High Density Lipoprotein cholesterol (and Low density Lipoprotein cholesterol calculated). Fasting plasma glucose and insulin (insulin sensitivity based on the calculated homeostasis model assessment index (HOMA)). Plasma androgens/hormonal status (testosterone, Sex Hormone Binding Globulin and free androgen index), nutritional status (dietary intake, serum ferritin, vitamin B12, folate), blood pressure, menstrual cyclicity (menstrual calendar), physical activity, hirsutism, attitudes and barriers towards weight loss program, psychological measures (self esteem, General Health Questionnaire, self-efficacy, locus of control, response efficacy), attrition.
Timepoint [1] 4420 0
Food intake and exercise levels will be measured at weeks 0, 12, 24 and 48. All other secondary outcomes will be measured at weeks 0 and 12.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation was concealed when it was done by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using computer software clinstat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1981 0
Government body
Name [1] 1981 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 1981 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation, Human Nutrition
Address
Country
Australia
Secondary sponsor category [1] 1794 0
None
Name [1] 1794 0
n/a
Address [1] 1794 0
Country [1] 1794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3679 0
CSIRO Human Nutrition
Ethics committee address [1] 3679 0
Ethics committee country [1] 3679 0
Australia
Date submitted for ethics approval [1] 3679 0
Approval date [1] 3679 0
01/02/2007
Ethics approval number [1] 3679 0
06/17

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27561 0
Address 27561 0
Country 27561 0
Phone 27561 0
Fax 27561 0
Email 27561 0
Contact person for public queries
Name 10816 0
Siew Lim
Address 10816 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10816 0
Australia
Phone 10816 0
+61 8 8303 8938
Fax 10816 0
+61 8 83038899
Email 10816 0
siew.lim@csiro.au
Contact person for scientific queries
Name 1744 0
Dr Manny Noakes
Address 1744 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1744 0
Australia
Phone 1744 0
+61 8 83038827
Fax 1744 0
+61 8 8303 8899
Email 1744 0
manny.noakes @csiro.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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