My Lifestyle Intervention of Food and Exercise (MyLIFE)

University of Florida

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Tailored Lifestyle Intervention (TLI); Behavioral: Commercial Weight Loss Program (CWLP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01630499

427-2012 (Other Identifier)

MyLIFE2012

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 2 patient groups

Tailored Lifestyle Intervention (TLI)

Experimental group

Description:

Participants randomized to the TLI condition will receive a 3-month weight management program tailored to the specific needs of women in remission from breast cancer.

Treatment:

Behavioral: Tailored Lifestyle Intervention (TLI)

Commercial Weight Loss Program (CLWP)

Active Comparator group

Description:

Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost.

Treatment:

Behavioral: Commercial Weight Loss Program (CWLP)