Baltimore, Maryland 21207


Purpose:

This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on IGF-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors


Criteria:

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- LHRH therapy for prostate cancer in men will be permitted. - Have a BMI of 25 kg/m2 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 eGFR<45 - Have significant hepatic dysfunction (AST/ALT ≥ 2 x 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 - 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.


NCT ID:

NCT02431676


Primary Contact:

Principal Investigator
Jessica Yeh, PhD
Johns Hopkins Medicine

Karen A White
Phone: 410-281-1600
Email: spirit@jhmi.edu


Backup Contact:

Email: jeannec@jhmi.edu
Jeanne Charleston
Phone: 410-281-1600


Location Contact:

Baltimore, Maryland 21207
United States

Karen White
Phone: 410-281-1600
Email: spirit@jhmi.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.