My Lifestyle Intervention of Food and Exercise

Study Overview
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Brief Summary
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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.

Official Title
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Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Tailored Lifestyle Intervention (TLI)
* Behavioral: Commercial Weight Loss Program (CWLP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Lifestyle Intervention (TLI)<br>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. | Behavioral: Tailored Lifestyle Intervention (TLI)<br>* The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.<br>|
| Active Comparator: Commercial Weight Loss Program (CLWP)<br>Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost. | Behavioral: Commercial Weight Loss Program (CWLP)<br>* This intervention is a generic, widely-available weight management program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from baseline to post-intervention |  | baseline (month 0), post-intervention (month 3) | 
| Change in body weight from post-intervention to follow-up |  | post-intervention (month 3), follow-up (month 9) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention |  | baseline (month 0), post-intervention (month 3) | 
| Change in HDL Cholesterol from baseline to post-intervention |  | baseline (month 0), post-intervention (month 3) | 
| Change in blood glucose control from baseline to post-intervention. | HgA1c and fasting glucose to assess blood glucose control | baseline (month 0), post-intervention (month 3) | 
| Change in caloric intake from baseline to post-intervention. | National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake. | baseline (month 0), post-intervention (month 3) | 
| Change in body composition from baseline to post-intervention. | Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc). | baseline (month 0), post-intervention (month 3) | 
| Change in waist circumference from baseline to post-intervention. | Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation. | baseline (month 0), post-intervention (month 3) | 
| Change in sagittal abdominal diameter from baseline to post-intervention. | Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation. | baseline (month 0), post-intervention (month 3) | 
| Change in physical activity from baseline to post-intervention. | Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ). | baseline (month 0), post-intervention (month 3) | 
| Change in health-related quality of life from baseline to post-intervention. | Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer - Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23). | baseline (month 0), post-intervention (month 3) | 
| Change in self-efficacy from baseline to post-intervention. | Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire. | baseline (month 0), post-intervention (month 3) | 
| Use of weight management strategies | The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ). | post-intervention (month 3) | 
| Height | Height will be assessed in order to determine BMI. | baseline (month 0) | 
| Change in blood pressure from baseline to post-intervention. | Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes. | post-intervention (month 3), follow-up (month 9) | 
| Change in LDL cholesterol at from baseline to post-intervention. |  | baseline (month 0), post-intervention (month 3) | 
| Change in total cholesterol from baseline to post-intervention. |  | baseline (month 0), post-intervention (month 3) | 
| Change in triglycerides from baseline to post-intervention. |  | baseline (month 0), post-intervention (month 3) | 
| Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up. |  | post-intervention (month 3), follow-up (month 9) | 
| Change in HDL Cholesterol from post-intervention to follow-up. |  | post-intervention (month 3), follow-up (month 9) | 
| Change in blood glucose control from post-intervention to follow-up. |  | post-intervention (month 3), follow-up (month 9) | 
| Change in caloric intake from post-intervention to follow-up. | National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake. | post-intervention (month 3), follow-up (month 9) | 
| Change in body composition from post-intervention to follow-up. | Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc). | post-intervention (month 3), follow-up (month 9) | 
| Change in waist circumference from post-intervention to follow-up. | Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation. | post-intervention (month 3), follow-up (month 9) | 
| Change in sagittal abdominal diameter from post-intervention to follow-up. | Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation. | post-intervention (month 3), follow-up (month 9) | 
| Change in physical activity from post-intervention to follow-up. | Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ). | post-intervention (month 3), follow-up (month 9) | 
| Change in health-related quality of life from post-intervention to follow-up. | Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer - Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23). | post-intervention (month 3), follow-up (month 9) | 
| Change in self-efficacy from post-intervention to follow-up. | Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire. | post-intervention (month 3), follow-up (month 9) | 
| Use of weight management strategies at follow-up. | The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ). | follow-up (month 9) | 
| Change in blood pressure from post-intervention to follow-up. | Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes. | post-intervention (month 3), follow-up (month 9) | 
| Change in LDL cholesterol at from post-intervention follow-up |  | post-intervention (month 3), follow-up (month 9) | 
| Change in total cholesterol from post-intervention to follow-up. |  | post-intervention (month 3), follow-up (month 9) | 
| Change in triglycerides from post-intervention to follow-up. |  | post-intervention (month 3), follow-up (month 9) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Breast cancer, Breast cancer prevention, Breast cancer recurrence, Weight loss, Weight management, Overweight, Obesity