My Lifestyle Intervention of Food and Exercise

University of Florida87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Breast Cancer

Interventions

Tailored Lifestyle Intervention (TLI)BEHAVIORAL

The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.

Commercial Weight Loss Program (CWLP)BEHAVIORAL

This intervention is a generic, widely-available weight management program.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Florida

Gainesville, Florida, United States

University of North Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Change in body weight from baseline to post-intervention

Time frame: baseline (month 0), post-intervention (month 3)

Change in body weight from post-intervention to follow-up

Time frame: post-intervention (month 3), follow-up (month 9)

Secondary Outcomes

Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention

Time frame: baseline (month 0), post-intervention (month 3)

Change in HDL Cholesterol from baseline to post-intervention

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: post-intervention (month 3)

Height

Height will be assessed in order to determine BMI.

Time frame: 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.

Time frame: post-intervention (month 3), follow-up (month 9)

Change in LDL cholesterol at from baseline to post-intervention.

Time frame: baseline (month 0), post-intervention (month 3)

Change in total cholesterol from baseline to post-intervention.

Time frame: baseline (month 0), post-intervention (month 3)

Change in triglycerides from baseline to post-intervention.

Time frame: baseline (month 0), post-intervention (month 3)

Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up.

Time frame: post-intervention (month 3), follow-up (month 9)

Change in HDL Cholesterol from post-intervention to follow-up.

Time frame: post-intervention (month 3), follow-up (month 9)

Change in blood glucose control from post-intervention to follow-up.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: 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.