No registrations found.
ID
Source
Health condition
PCOS, overweight, children, high BMI, lifestyle, intervention, therapy, cognitive behavioural therapy, diet therapy, physical activity
Sponsors and support
Intervention
Outcome measures
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).
Background 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.
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.
Study objective
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?
Study design
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).
Intervention
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.
Geranne Jiskoot
Erasmus MC, Dept. of Reproductive Medicine, Room HS-423
Rotterdam 3000 CA
The Netherlands
+31 (0)6 44184834
L.jiskoot@erasmusmc.nl
Geranne Jiskoot
Erasmus MC, Dept. of Reproductive Medicine, Room HS-423
Rotterdam 3000 CA
The Netherlands
+31 (0)6 44184834
L.jiskoot@erasmusmc.nl
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. Psychiatric disorder;
3. Obesity with other somatic causes;
4. Ovarian tumors that result in androgen excess;
5. Adrenal diseases;
6. Other malformations of internal genitalia;
7. Pregnancy.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2344 |
| NTR-old | NTR2450 |
| Other | METC Erasmus MC : 2008-337 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |