Clinical trial NCT01630499: My Lifestyle Intervention of Food and Exercise
Official title: Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Cancer
Breast cancer
Breast cancer prevention
Breast cancer recurrence
Weight loss
Weight management
Overweight
Obesity
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 87
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight from baseline to post-intervention
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in body weight from post-intervention to follow-up
timeFrame: post-intervention (month 3), follow-up (month 9)
Secondary outcomes:
measure: Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in HDL Cholesterol from baseline to post-intervention
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in blood glucose control from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in caloric intake from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in body composition from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in waist circumference from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in sagittal abdominal diameter from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in physical activity from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in health-related quality of life from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in self-efficacy from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Use of weight management strategies
timeFrame: post-intervention (month 3)
measure: Height
timeFrame: baseline (month 0)
measure: Change in blood pressure from baseline to post-intervention.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in LDL cholesterol at from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in total cholesterol from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in triglycerides from baseline to post-intervention.
timeFrame: baseline (month 0), post-intervention (month 3)
measure: Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in HDL Cholesterol from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in blood glucose control from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in caloric intake from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in body composition from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in waist circumference from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in sagittal abdominal diameter from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in physical activity from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in health-related quality of life from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in self-efficacy from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Use of weight management strategies at follow-up.
timeFrame: follow-up (month 9)
measure: Change in blood pressure from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in LDL cholesterol at from post-intervention follow-up
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in total cholesterol from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
measure: Change in triglycerides from post-intervention to follow-up.
timeFrame: post-intervention (month 3), follow-up (month 9)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of North Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Anne Mathews, PhD, RD
role: PRINCIPAL_INVESTIGATOR
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