Weight loss and exercise in PCOS Study 2006

Phase 4

Completed

• Conditions: Obesity; Polycystic ovary sydrome (PCOS); Diet and Nutrition - Obesity; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12606000198527
• Lead Sponsor: CSIRO Human Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Overweight or obese PCOS
Generally healthy with no chronic or acute diseases or disorders
Not pregnant or breast feeding.

Exclusion Criteria

Known cardiovascular disease, current smoking, diabetes mellitus uncontrolled hypertension, proteinuria, a malignancy, a history of liver, kidney or respiratory disease, or are pregnantUnrelated reproductive disorders. thyroid abnormalities (hypo- and hyperthyroidism), non-classic adrenal hyperplasia as assessed by fasting or acetylthiocholine (ATCH)-stimulated serum 17-hydroxyprogesterone).Fertility treatment such as clomiphene citrate or In-Vitro Fertilisation (IVF), insulin-sensitising agents (participation will be allowed upon discontinuation of therapy for one month prior to intervention).Oral contraceptive use (participation will be allowed upon discontinuation of oral contractive therapy one month prior to intervention). Participations will be required to use barrier contraception throughout the study intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss[At baseline and 10 and 20 weeks after start of lifestyle interventions];Reproductive function[At baseline and 10 and 20 weeks after start of lifestyle interventions]

Secondary Outcome Measures

Name	Time	Method
Body composition,lipids,insulin sensitivity, and glucose.[At baseline and 10 and 20 weeks after start of lifestyle interventions];Quality of life assessed using PCOSQ[At baseline and 10 and 20 weeks after start of lifestyle interventions];Depression assessed using the Center for Epidemiological Studies-Depression scale<br>[At baseline and 10 and 20 weeks after start of lifestyle interventions];Perceived benefits from exercise and barriers to exercise assessed using the Exercise Benefits/Barriers Scale[At baseline and 10 and 20 weeks after start of lifestyle interventions]