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Lifestyle changes in women with polycystic ovary syndrome (PCOS), overweight and a wish to have children.


- candidate number8297
- NTR NumberNTR2450
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2010
- Secondary IDs2008-337 METC Erasmus MC
- Public TitleLifestyle changes in women with polycystic ovary syndrome (PCOS), overweight and a wish to have children.
- Scientific TitlePCOS and overweight.
- ACRONYM
- hypothesis1. Is a multidisciplinary cognitive behavioural lifestyle program more effective in losing weight and permanent weight loss for women with PCOS and obesity then regular care?
2. Is a multidisciplinary cognitive behavioural lifestyle program in combination with SMS-interventions more effective in losing weight and permanent weight loss then a multidisciplinary cognitive behavioural lifestyle program without SMS-intervention?
3. Is a multidisciplinary cognitive behavioural lifestyle program in combination with SMS-intervention effective on the menstrual cycle, the anthropomorphic morphometric- , ultrasound-, endocrine- and psychological parameters , as well as physical activity?
- Healt Condition(s) or Problem(s) studiedOverweight, Infertility, Polycystic ovary syndrome (PCOS), Cognitive behavior therapy, Children
- Inclusion criteria1. PCOS;
2. Wish to have children;
3. Body Mass index above 25;
4. Age: from 18 to 38.
- Exclusion criteria1. Not able to speak and understand the Dutch language;
2. Not enough motivation;
3. Psychiatric disorder;
4. Obesity with other somatic causes;
5. Ovarian tumors that result in androgen excess;
6. Adrenal diseases;
7. Other malformations of internal genitalia;
8. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-sep-2014
- Target number of participants234
- InterventionsA nine month during lifestyle change program focusing on sustainable eating and living habits, using SMS with the aim of sustainable weight loss. The team is consisting of a psychologist, a dietician, a physiotherapist and a gynecologist.
- Primary outcomeBMI.
- Secondary outcome1. Cycle duration;
2. Cycle regularity;
3. Anthropomorfometrische results (blood results);
4. Ultrasound findings;
5. Endocrine outcomes;
6. Physical activity (IPAQ);
7. Psychological outcomes (SF 36, PCOSQ, BDI, RSE, FNAES, EDE-Q).
- Timepoints1. Before the study (T0);
2. After 3 months (T1);
3. After 6 months (T2);
4. After 9 months (T3);
5. After 12 months (T4).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Geranne Jiskoot
- CONTACT for SCIENTIFIC QUERIESProf. Joop S.E. Laven
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryPurpose:
Evaluation of the effectiveness of a multidisciplinary cognitive-behavioral program combined with a lifestyle maintenance via Short Message Service (SMS) in infertile women with PCOS and overweight or obese.

Study design:
RCT with 3 groups. At the start of the study participants were randomized in a 2:1 ratio in a treatment group ( n = 156) and a control group (n = 78) . After three months the treatment group will be randomized into two groups. One group receives an SMS maintenance ( n = 78) the other group will not.
- Main changes (audit trail)
- RECORD2-aug-2010 - 14-aug-2010


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