My Lifestyle Intervention of Food and Exercise
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. We hypothesize that an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits compared to an existing commercial program.
Key facts
- Study ID
- NCT01630499
- Run by
- University of Florida
- People needed
- 87
- Starts
- 2012-10-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2016-09-30
Who can join
Age: 21 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- Age 21 to 65
- History of stage 1, 2, or 3 breast cancer
- Completed primary treatments (chemotherapy, radiation, and/or surgical treatment) for breast cancer (with or without maintenance therapy) within the last 3 months to 5 years of providing consent
- Be willing/able to attend groups and assessments in Gainesville or Jacksonville
- BMI of 27 to 45 kg/m2
- Weight-stable, i.e., not lost/gained ≥ 10 lbs in the preceding 6 months, or since the end of primary treatment
You may not qualify if…
- History of bariatric surgery
- Pregnant, lactating, or planning on becoming pregnant in next 12 months.
- Irritable bowel syndrome
- Serious infectious disease
- Chronic malabsorption syndrome
- Uncontrolled angina within the past 6 months
- History of musculo-skeletal or chronic lung diseases that limit physical activity
- Serum creatinin > 1.5 mg/dL
- Uncontrolled or insulin-dependent diabetes (i.e., hemoglobin A1c< 10 g/dL, fasting serum triglycerides > 400 mg/dL; oral medications are not exclusionary)
- At-rest blood pressure > 140/90 mg/Hg
- Myocardial infarction
- Stroke
- Congestive heart failure
- Chronic hepatitis
- Cirrhosis
- Chronic pancreatitis
- History of solid organ transplantation
- Cancer treatment within past 5 years (other than for breast cancer)
- Any other physical condition (other than history of breast cancer) deemed likely to limit 5-year life expectancy or significantly interfere with individuals' ability to participate in a lifestyle intervention involving eating and physical activity changes.
- Use of antipsychotic medications, monoamine oxidase inhibitors, systemic corticosteroids, human immunodeficiency virus or tuberculosis antibiotics, chemotherapeutics medications, or weight-loss medications.
- Significant psychiatric disorder
- Illicit drug use or excessive use of alcohol (i.e., > 2 drinks/day)
- Currently participating in Weight Watcher's or another weight loss program
- Currently participating in another research study
- Unable to read English at the 5th grade level
Where it is running
- University of Florida — Gainesville, Florida, United States
- University of North Florida — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.