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Table 6 Outcomes measures (T0, T1, T2, T3, T4)

From: A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): a protocol for a randomized controlled trial

Primary outcome

Weight in kilograms

Secondary outcomes

(1) reproductive outcomes:

a) cycle duration and frequency

b) spontaneous pregnancies

2) anthropomorphometric outcomes:

a) BMI

b) waist circumference (WC)

c) hip circumference (HC)

d)WC/HC ratio

(3) clinical and biochemical PCOS features:

a) hair growth pattern

- Ferriman Gallwey score

b) blood pressure

c) transvaginal ultrasound outcomes

- ovarian volume

- follicle count

- total follicles per ovary

d) endocrine outcomes

- insulin resistance

- hyperandrogenism

- dyslipidemia

(4) psychological outcomes:

a) eating behaviour and disturbances

- The Dutch Eating Behaviour Questionnaire (NVE)

- Eating Disorder Examination Questionnaire (EDE-Q)

b) quality of Life

- Short Form 36 (SF-36)

- Polycystic Ovary Syndrome Questionnaire (PCOSQ)

c) depression

- Beck Depression Inventory (BDI)

d) self-esteem

- Rosenberg Self Esteem Scale (RSE)

e) fear of negative appearance

- Fear of Negative Appearance Evaluation Scale (FNAES)

f) satisfaction

- Self-constructed questionnaire

(5) physical activity:

a) perceived level of daily physical activity

- the International Physical Activity Questionnaire (IPAQ)

b) the intervention group: submaximal bicycle test

(5) physical activity:

a) food intake

-energy (calories)

- protein

- fat

- saturated fat

- carbohydrates

- mono- and disaccharides

- drinks (ml)

(7) other:

- attendance at meetings

- drop-out and reasons for drop-out