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The Female Health Dietary Intervention Study (FEMIN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by The Hospital of Vestfold.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by:
The Hospital of Vestfold
ClinicalTrials.gov Identifier:
NCT00779571
First received: October 22, 2008
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

This study has two phases:

  1. 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.
  2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.

Condition Intervention
Polycystic Ovary Syndrome
Morbid Obesity
 Behavioral: Lifestyle counseling

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital of Vestfold:

Primary Outcome Measures:
  • Weight loss [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
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)
Intervention Details:
    Behavioral: Lifestyle counseling
    8 week low calorie diet
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman (European Caucasian)
  • PCOS
  • BMI = or > 35

Exclusion Criteria:

  • Cushing syndrome
  • Adrenal hyperplasia
  • Androgen-producing tumors
  • Anovulation caused by hyperprolactinemia
  • Pregnancy, breast feeding
  • Use of oral contraceptives/hormone treatment/insulin-sensitizing agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779571

Locations
Norway
Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF
Oslo, Norway
Sponsors and Collaborators
The Hospital of Vestfold
Oslo University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Line Kristin Johnson, MSc, The Hospital of Vestfold
ClinicalTrials.gov Identifier: NCT00779571     History of Changes
Other Study ID Numbers: 86-814d 6.2008.453
Study First Received: October 22, 2008
Last Updated: June 22, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by The Hospital of Vestfold:
Polycystic Ovary Syndrome
Morbid Obesity
Type 2 DM
Coronary heart disease

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Polycystic Ovary Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013