Table 1 Details of the proposed RCT methodology which were provided to participants

Design

Two group parallel design RCT comparing real acupuncture with sham with both groups also receiving lifestyle coaching. Women will have a 50% chance of being allocated to receive either real or sham acupuncture.

Population

Women with PCOS who are overweight or obese

Interventions

All women will receive lifestyle coaching over the telephone (ten 15-min phone calls over 6 months), and will set their own diet and exercise goals, with an aim to achieve the national guideline recommendations for diet [52] and exercise [53].

The intervention group will also receive 12 treatments of real acupuncture over 12 weeks (45 min sessions delivered twice weekly for the first 4 weeks and then fortnightly for 4 sessions).

Control

As well as lifestyle coaching, the control group will also receive 12 treatments of sham acupuncture over 12 weeks (45 min sessions delivered twice weekly for the first 4 weeks and then fortnightly for 4 sessions). Sham needling (referred to as “placebo acupuncture” in the participant information) is when needles are not inserted in the way they are done usually, and is therefore believed to be less active than real acupuncture.

Outcomes

Primary outcome: weight loss.

Secondary outcomes: two hour Oral Glucose Tolerance Test and other blood tests, surveys on different aspects of health

Blinding

Women will be blinded.