Survivorship Promotion In Reducing IGF-1 Trial

Recruitment & Eligibility

Inclusion Criteria

Women and men ages 18 or older
Have been previously diagnosed with a malignant solid tumor, completed their required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- Luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted.
Have a BMI of 25 kg/m^2 or greater and weight <=400 lbs.
Willingness to accept randomization to each of the three arms
Willingness to change diet, physical activity, and weight
Regular access to computer with a reliable Internet connection
Ability to send and receive emails
Ability to complete online forms
Access to phone
Willingness to provide written informed consent

Exclusion Criteria

Women who are breastfeeding, pregnant, or planning pregnancy within the next year
Medication-treated diabetes
Fasting blood glucose >=200 mg/dL, or fasting blood glucose >=126 and <200 mg/dL and HbA1C >=7%
Current or prior regular use of metformin within the past 3 months
Uncontrolled concurrent medical condition likely to limit compliance with the study interventions
Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed intervention date
Have a prior history of lactic acidosis by self-report
Prior or planned bariatric surgery
Have significant renal disease or dysfunction defined as Estimated glomerular filtration rate (eGFR)<45
Have significant hepatic dysfunction [Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≥ 2 x upper limit of normal (ULN) or reported liver disease]
Self-reported average consumption of > 14 alcoholic drink per week
Currently enrolled or planned to enroll in weight loss program
Hemoglobin <9 g/dl
Platelet count <100
White blood cell count (WBC) <2.5
Plans to relocate from the area within one years
Use of prescription weight loss medication(s) (e.g., lorcaserin, topiramate/phentermine, phentermine, liraglutide, and bupropion/naltrexone), including off label use of drugs for weight loss or over-the-counter weigh loss medications such as Orlistat within the past 6 months.

Study & Design

Arm && Interventions

Group	Intervention	Description
Self-Directed	Self-control weight loss	In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Coach Directed Behavioral Weight Loss	Coach Directed Behavioral Weight Loss	The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Metformin	Metformin	This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals

Primary Outcome Measures

Name	Time	Method
IGF-1 Levels	6 months	Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.

Secondary Outcome Measures

Name	Time	Method
IGF-1 Levels	12 months	IGF-1 at 12 months
IGF-1 to IGFBP3 Level Ratio (Molar Ratio)	6 months	IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.

Recruitment & Eligibility