The Female Health Dietary Intervention Study (FEMIN)
Recruitment status was Active, not recruiting
This study has two phases:
- In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
- In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study|
- Weight loss [ Time Frame: One year ] [ Designated as safety issue: No ]
- Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Behavioral: Lifestyle counseling
Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.
|Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF|
|Principal Investigator:||Jøran Hjelmesæth, MD, PhD||The Hospital of Vestfold|
|Study Chair:||Tom Tanbo, MD, PhD||Oslo University Hospital|
|Principal Investigator:||Kirsten B Holven, PhD||University of Oslo|
|Principal Investigator:||Line Kristin Johnson, MSc||Oslo University Hospital|