My Lifestyle Intervention of Food and Exercise
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | March 2016 |
Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Unable/unwilling to provide informed consent
- Unwilling to receive random assignment to TLI or CWLP
We found this trial at
2
sites
Click here to add this to my saved trials
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials