My Lifestyle Intervention of Food and Exercise

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Commercial Weight Loss Program (CWLP); Behavioral: Tailored Lifestyle Intervention (TLI)

• Registration Number: NCT01630499
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Study Start: 2012-10
• Primary Completion: 2016-03
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Commercial Weight Loss Program (CLWP)	Commercial Weight Loss Program (CWLP)	Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost.
Tailored Lifestyle Intervention (TLI)	Tailored Lifestyle Intervention (TLI)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.	baseline (month 0), post-intervention (month 3)	HgA1c and fasting glucose to assess blood glucose control
Change in caloric intake from baseline to post-intervention.	baseline (month 0), post-intervention (month 3)	National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake.
Change in body composition from baseline to post-intervention.	baseline (month 0), post-intervention (month 3)	Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).
Change in waist circumference from baseline to post-intervention.	baseline (month 0), post-intervention (month 3)	Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation.
Change in sagittal abdominal diameter from baseline to post-intervention.	baseline (month 0), post-intervention (month 3)	Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation.
Change in physical activity from baseline to post-intervention.	baseline (month 0), post-intervention (month 3)	Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ).
Change in health-related quality of life from baseline to post-intervention.	baseline (month 0), post-intervention (month 3)	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).
Change in self-efficacy from baseline to post-intervention.	baseline (month 0), post-intervention (month 3)	Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire.
Use of weight management strategies	post-intervention (month 3)	The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).
Change in sagittal abdominal diameter from post-intervention to follow-up.	post-intervention (month 3), follow-up (month 9)	Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation.
Height	baseline (month 0)	Height will be assessed in order to determine BMI.
Change in blood pressure from baseline to post-intervention.	post-intervention (month 3), follow-up (month 9)	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.
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.	post-intervention (month 3), follow-up (month 9)	National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake.
Change in body composition from post-intervention to follow-up.	post-intervention (month 3), follow-up (month 9)	Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).
Change in waist circumference from post-intervention to follow-up.	post-intervention (month 3), follow-up (month 9)	Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation.
Change in physical activity from post-intervention to follow-up.	post-intervention (month 3), follow-up (month 9)	Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ).
Change in health-related quality of life from post-intervention to follow-up.	post-intervention (month 3), follow-up (month 9)	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).
Change in self-efficacy from post-intervention to follow-up.	post-intervention (month 3), follow-up (month 9)	Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire.
Use of weight management strategies at follow-up.	follow-up (month 9)	The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).
Change in blood pressure from post-intervention to follow-up.	post-intervention (month 3), follow-up (month 9)	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.
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)

Trial Locations

Locations (2)

University of North Florida; 🇺🇸 Jacksonville, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States