No registrations found.
ID
Source
Brief title
Health condition
PCOS, overweight, obesity, lifestyle intervention, three-component, cognitive behavioral therapy, diet, exercise.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The long-term affect of a three-component lifestyle intervention (with or without SMS support) on weight compared to care as usual.
Secondary outcome
The long-term affect of a three-component lifestyle intervention (with or without SMS support) on BMI, waist and hip circumference, emotional well-being, PCOS characteristics, PCOS phenotype, and metabolic health compared to care as usual.
Background summary
The aim is to evaluate the long term effects (+- five years post-intervention) of a previously performed one-year three-component randomized controlled trial (the 'PCOS and overweight' study; NTR2450). Outcome measures include weight, BMI, waist and hip circumference, PCOS characteristics and phenotype, emotional well-being, and metabolic health.
The 'PCOS and overweight' study was a one-year three-component (diet, exercise, cognitive behavioral therapy) lifestyle intervention, with or without SMS support, compared to control (care as usual e.g. an advice to lose weight autonomously). This study has been performed between 2010 and 2016.
Study objective
We hypothesize that women who received the one-year three-component lifestyle intervention will have more sustainable changes approximately 5 years after the study with regard to weight, PCOS characteristics, metabolic health, and emotional well-being when compared to care as usual.
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).
(the above 5 time points have already been completed in the 'PCOS and overweight' study)
New time point:
6. At least approximately 5 years after the 'PCOS and overweight' study (T5).
Intervention
N/A
Alexandra Dietz de Loos
+31 (0)6 22666365
a.dietzdeloos@erasmusmc.nl
Alexandra Dietz de Loos
+31 (0)6 22666365
a.dietzdeloos@erasmusmc.nl
Inclusion criteria
- Previous participation in the ‘PCOS and overweight’ study.
- Informed consent.
Exclusion criteria
- None.
Design
Recruitment
IPD sharing statement
Plan description
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 | NL9502 |
Other | METC Erasmus MC : MEC-2021-0197 |