Primary: Evaluation of the effectivity of a multidisciplinary cognitive behavioural lifestyle program combined with a Short Message Service (SMS) maintenance treatment with infertile overweight and obese PCOS women.
ID
Source
Brief title
Condition
- Other condition
- Endocrine disorders of gonadal function
- Ovarian and fallopian tube disorders
Synonym
Health condition
Overgewicht en obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body Mass Index (BMI).
Secondary outcome
Cycle duration, cycle regularity, anthropomorphometric outcomes, echoscopic
oucomes, endocrine outcomes and psychological outcomes.
Background summary
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders
in women of reproductive age. 50-60% of the women with PCOS are overweight or
obese. PCOS women are often insulin resistant, but especially the obese
patients are at higher risk for developing type II Diabetes Mellitus. There is
evidence that PCOS women have an increased risk of heart disease. When PCOS
women are pregnant, they have more miscarriages than women without PCOS.
Overweight and obese PCOS women are more at risk for the short- and long term
consequences. Obesity and overweight influence the outcome of fertility
treatments in a negative sense. Before overweight and obese PCOS women undergo
a fertility treatment, there should be weight reduction to lower the health
risks. At the moment, there are no special treatments in the Netherlands to
reduce the overweight in PCOS women. Cognitive behavioural treatments are the
most effective treatments to achieve weight reduction, especially when combined
with an excercise program and advice from a dietician. Weight reduction of 5
percent can already lead to spontanious ovulations and pregnancy in PCOS women,
lowers the miscarriage percentage and leads to less complications during
pregnancy. On the long term, weight reduction decreases the risk for developing
type II Diabetes Mellitus.
Study objective
Primary: Evaluation of the effectivity of a multidisciplinary cognitive
behavioural lifestyle program combined with a Short Message Service (SMS)
maintenance treatment with infertile overweight and obese PCOS women.
Study design
Randomized control trial with 3 groups. Patients are randomized according a 2:1
ratio in a treatment group (n=156) and in a control group (n=78). After six
months of treatment, the treatment group will be randomized in 2 groups. One
group receives the maintenance treatment through SMS, the other group doesn't
receive the SMS maintenance treatment.
Intervention
A lifestyle program (nine months) focussing on persisting lifestyle behaviour
changes in infertile overweight and obese PCOS women and a Short Message
Service (SMS) Maintenance treatment for support and lifestyle maintenance.
Study burden and risks
The extent of burden that is associated with participation is 1 hour excercise
program (physiotherapist), 2 hours cognitive behavioural group treatment
(psychologist and dietician): The multidisciplinary program is the first three
months weekly, the three months thereafter two times a month and the last three
months monthly. The extent of burden is on five measurement moments one hour
for measures and questionnaires (physican). The risks associated with
participation is related to bloodsampling. There is a small chance for bruises
and extravasation of blood. The location of bloodsampling can be sensitive
afterwards. All physical examinations are harmless for the health of the
participants.
Dr. Molewaterplein 50
Rotterdam 3000 CA
NL
Dr. Molewaterplein 50
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
Polycystic ovary syndrome
Body Mass index higher dan 25 kg/m2
Wish to have children
Age between 18 and 40 years
Exclusion criteria
Insufficient in the Dutch language
Patients with a psychiatric disorder
Obesity in the context of a somatic disease
Ovarial tumours leading to androgen excess
Adrenal diseases
Disorders genitalia interna
Pregnancy
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT2450 |
| CCMO | NL24537.078.08 |