Young women and weight loss study 2007

Phase 4

Recruiting

• Conditions: Obesity in young women; Diet and Nutrition - Obesity

• Registration Number: ACTRN12607000213448
• Lead Sponsor: Commonwealth Scientific Industrial Research Organisation, Human Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight [At weeks 0, 12, 24 and 48];Body composition [At weeks 0, 12]

Secondary Outcome Measures

Name	Time	Method
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.[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.]