Survivorship Promotion In Reducing IGF-1 Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-12-31

Brief Summary

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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 insulin-like growth factor (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

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Detailed Description

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Conditions

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Breast Cancer Prostate Cancer Lung Cancer Colon Cancer Melanoma of Skin Endometrial Cancer Liver Cancer Pancreatic Cancer Rectal Cancer Kidney Cancer Other Solid Malignant Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Self-Directed

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.

Group Type ACTIVE_COMPARATOR

Self-control weight loss

Intervention Type BEHAVIORAL

Coach Directed Behavioral Weight Loss

The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight

Group Type EXPERIMENTAL

Coach Directed Behavioral Weight Loss

Intervention Type BEHAVIORAL

Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals

Metformin

This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.

Interventions

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Metformin

Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.

Intervention Type DRUG

Coach Directed Behavioral Weight Loss

Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals

Intervention Type BEHAVIORAL

Self-control weight loss

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No