|- candidate number||8297|
|- NTR Number||NTR2450|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-aug-2010|
|- Secondary IDs||2008-337 METC Erasmus MC|
|- Public Title||Lifestyle changes in women with polycystic ovary syndrome (PCOS), overweight and a wish to have children.|
|- Scientific Title||PCOS and overweight.|
|- hypothesis||1. 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) studied||Overweight, Infertility, Polycystic ovary syndrome (PCOS), Cognitive behavior therapy, Children|
|- Inclusion criteria||1. PCOS;|
2. Wish to have children;
3. Body Mass index above 25;
4. Age: from 18 to 38.
|- Exclusion criteria||1. 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;
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-sep-2014|
|- Target number of participants||234|
|- Interventions||A 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 outcome||BMI.|
|- Secondary outcome||1. 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).
|- Timepoints||1. 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 site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Geranne Jiskoot|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Joop S.E. Laven|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||Purpose:|
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.
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)|
|- RECORD||2-aug-2010 - 14-aug-2010|