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-…
ID
Bron
Verkorte titel
Aandoening
PCOS, overweight, obesity, lifestyle intervention, three-component, cognitive behavioral therapy, diet, exercise.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The long-term affect of a three-component lifestyle intervention (with or without SMS support) on weight compared to care as usual.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
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).
(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).
Onderzoeksproduct en/of interventie
N/A
Algemeen / deelnemers
Alexandra Dietz de Loos
+31 (0)6 22666365
a.dietzdeloos@erasmusmc.nl
Wetenschappers
Alexandra Dietz de Loos
+31 (0)6 22666365
a.dietzdeloos@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Previous participation in the ‘PCOS and overweight’ study.
- Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- None.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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In overige registers
Register | ID |
---|---|
NTR-new | NL9502 |
Ander register | METC Erasmus MC : MEC-2021-0197 |