The aim is to evaluate long-term (+/- five years post-intervention) follow-up results of a previously completed study that investigated the effect of a three-component (diet, exercise, cognitive behavioural therapy (CBT)) lifestyle intervention with…
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anthropometric measurements approximately 5 years after participating in the
*PCOS en overgewicht* lifestyle study.
Secondary outcome
Transvaginal ultrasound, endocrine assessment and psychological outcomes
approximately 5 years after participating in the *PCOS en overgewicht*
lifestyle study.
Background summary
Overweight and obesity substantially increase the inherent health risks and
phenotypical features in women with polycystic ovary syndrome (PCOS). It also
has a negative impact on the chance to become pregnant and pregnancy outcome.
Three-component lifestyle interventions are recommended as first line therapy
in overweight and obese women with PCOS. However, evidence on long-term effects
of three-component lifestyle interventions is still lacking.
Study objective
The aim is to evaluate long-term (+/- five years post-intervention) follow-up
results of a previously completed study that investigated the effect of a
three-component (diet, exercise, cognitive behavioural therapy (CBT)) lifestyle
intervention with or without additional Short Message Service (SMS) support
compared to a control group (care as usual e.g. an advise to lose weight) (MEC
2008-337). The main objective of the current study is to determine long-term
physical outcomes, other objectives include psychological outcomes, PCOS
diagnosis and metabolic health.
Study design
Cross-sectional follow-up of a previously completed randomized controlled trial
comparing three groups, 1) lifestyle intervention with SMS, 2) lifestyle
intervention without SMS and 3) care as usual.
Study burden and risks
Women who participated previously in the *PCOS en overgewicht* lifestyle study
will be invited once for a COLA-screening (Cycle OLigo- or
Amenorrhea-screening) at our outpatient clinic which is part of our standard
care for women with irregular menstrual cycles. During the COLA-screening women
will have to complete questionnaires, a transvaginal ultrasound is performed as
well as a physical examination (e.g. blood pressure, weight, waist and hip
circumference). Eventually, venous blood sampling will be performed for
endocrine assessment. This visit could comprise a burden for these women,
however, the international PCOS guideline advises regular (health) check-ups
for women with PCOS. Therefore, this visit could also count as a benefit for
these women. The risk of participating in this study is related to the blood
withdrawal, because there is a small chance of haemorrhage or sore feeling at
the site of injection.
Dr. Molewaterpein 40
Rotterdam 3015GD
NL
Dr. Molewaterpein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Previous participation in the 'PCOS and overweight' study
Exclusion criteria
No previous participation in the 'PCOS and overweight' study
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 |
|---|---|
| CCMO | NL76910.078.21 |