An interventional study of Tailored Lifestyle Intervention (TLI) and Commercial Weight Loss Program (CWLP) in Breast Cancer, sponsored by University of Florida. Completed at 2 sites in United States. Open to female participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-30.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 87 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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)
The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.
This intervention is a generic, widely-available weight management program.
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)
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.
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.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in LDL cholesterol at from post-intervention follow-up
Time frame: post-intervention (month 3), follow-up (month 9)
Change in total cholesterol from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in triglycerides from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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University of Florida