Yeh 2015.

Trial name or title	Survivorship Promotion In Reducing IGF‐1 Trial (SPIRIT)
Methods	Parallel‐design, single‐blinded, three‐arm, randomised controlled trial
Participants	Women and men aged 18 years and older, with a prior diagnosis of a solid malignancy (including endometrial cancer), who have completed surgical, chemo‐ or radiation therapy at least three months previously and with an anticipated treatment‐free lifespan of more than 12 months, BMI greater than or equal to 25 kg/m2 and less than 400 lbs, with internet and phone access and willingness to change diet, physical activity and weight.
Interventions	Active Comparator: Self‐Directed. Meeting with trial team at beginning of study and provision of written information about weight management Experimental: Coach‐Directed Behavioral Weight Loss.Remote Lifestyle Coaching Intervention‐behaviour based telephonic coaching with web‐based support to promote healthy lifestyle and weight loss. The goal of the intervention is to achieve at least 5% weight loss in the first six months and to maintain these improvements through month 12 by meeting dietary and exercise goals Experimental: Metformin up to 2000 mg per day. Dosing can be flexible, depending on tolerance, and given 2‐3 times per day orally with meals for 12 months
Outcomes	Primary outcome measures: IGF‐1 levels, IGF‐1:IGFBP3 ratio at 6 months Secondary outcome measures: IGF‐1 levels, IGF‐1:IGFBP3 ratio at 12 months Other outcome measures: change in weight, BMI, dietary intake, physical activity, glucose, insulin, HbA1C, IL‐8, CRP levels and side effects in experimental arms
Starting date	May 2015
Contact information	Jessica Yeh, John Hopkins, Maryland, USA
Notes	Clinical Trials.gov identifier: NCT02431676

BMI: body mass index; CA‐125: cancer antigen 125; CRP: C‐reactive protein; CT: computed tomography; iGF‐1: insulin growth factor; IGFBP‐3: insulin‐like growth factor binding protein‐3; IL‐8: interleukin‐8; MRI: magnetic resonance imaging