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Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

21 Years
65 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

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 ≥ 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change in body weight from baseline to post-intervention

Outcome Time Frame:

baseline (month 0), post-intervention (month 3)

Safety Issue:


Principal Investigator

Anne Mathews, PhD, RD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • Cancer
  • Breast cancer
  • Breast cancer prevention
  • Breast cancer recurrence
  • Weight loss
  • Weight management
  • Overweight
  • Obesity
  • Breast Neoplasms



University of FloridaGainesville, Florida  32610-0277
University of North FloridaJacksonville, Florida  32224