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…
ID
Bron
Aandoening
PCOS, overweight, children, high BMI, lifestyle, intervention, therapy, cognitive behavioural therapy, diet therapy, physical activity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
BMI.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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?
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
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.
Publiek
Geranne Jiskoot
Erasmus MC, Dept. of Reproductive Medicine, Room HS-423
Rotterdam 3000 CA
The Netherlands
+31 (0)6 44184834
L.jiskoot@erasmusmc.nl
Wetenschappelijk
Geranne Jiskoot
Erasmus MC, Dept. of Reproductive Medicine, Room HS-423
Rotterdam 3000 CA
The Netherlands
+31 (0)6 44184834
L.jiskoot@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. PCOS;
2. Wish to have children;
3. Body Mass index above 25;
4. Age: from 18 to 38.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2344 |
NTR-old | NTR2450 |
Ander register | METC Erasmus MC : 2008-337 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |