Weight Loss Research Study for Better Health – Colorectal Polyps

STUDY BASICS

Did you have a colonoscopy with a polyp found and removed? Are you 18-84 years old? If so, you may be able to take part in a research study investigating how lifestyle changes affect weight, fitness level, quality of life, and certain biomarkers in people with a history of colorectal polyps. Compensation provided.

STUDY PURPOSE

Colorectal polyps—small clumps of cells that form in the lining of the colon—are very common and affect about one in three Americans during their lifetime. People often have their colorectal polyps completely removed through surgery, but there is a chance that they will come back. Some studies have shown that excess body weight and low levels of physical activity increase the risk that colorectal polyps will return. The purpose of this research study is to find out how diet and exercise programs affect weight, activity levels, quality of life, and biomarkers in people with a history of colorectal polyps. Biomarkers, or biological markers, are measurable substances in bodily fluids or tissues that can provide information about the body and may signal the presence of a condition or disease. Researchers hope their findings will lead to new ways to treat people with colorectal polyps and reduce the risk of cancer development in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18-84
• History of a colorectal polyp, under surveillance with no current sign of disease
• BMI (body mass index) of at least 25 but less than 40

WHAT PARTICIPANTS CAN EXPECT

After an initial visit to find out if you are eligible for the study, participants will be randomly assigned (like the flip of a coin) to one of two weight control programs. Both programs are 6 months long and involve being placed on a diet, meetings in-person and/or over the phone, and study assessments taken before, during, and after the weight control program. One program includes an exercise component (walking) and the other does not. Assessments during the study include self-report forms, questionnaires, urine and blood samples, and physical measurements (body weight, blood pressure, fitness levels, etc.). Your active participation in the study will last about 6 months, followed by a blood draw 12 months after joining the study, and yearly review of your medical records for up to 4 years.