My Lifestyle Intervention of Food and Exercise (MyLIFE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01630499
First received: June 22, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Tailored Lifestyle Intervention (TLI)
Behavioral: Commercial Weight Loss Program (CWLP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in body weight from baseline to post-intervention [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
  • Change in body weight from post-intervention to follow-up [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Change in HDL Cholesterol from baseline to post-intervention [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
  • Change in blood glucose control from baseline to post-intervention. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
    HgA1c and fasting glucose to assess blood glucose control

  • Change in caloric intake from baseline to post-intervention. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
    Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).

  • Change in waist circumference from baseline to post-intervention. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
    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 [ Time Frame: post-intervention (month 3) ] [ Designated as safety issue: No ]
    The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).

  • Height [ Time Frame: baseline (month 0) ] [ Designated as safety issue: No ]
    Height will be assessed in order to determine BMI.

  • Change in blood pressure from baseline to post-intervention. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
  • Change in total cholesterol from baseline to post-intervention. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
  • Change in triglycerides from baseline to post-intervention. [ Time Frame: baseline (month 0), post-intervention (month 3) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change in HDL Cholesterol from post-intervention to follow-up. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
  • Change in blood glucose control from post-intervention to follow-up. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
  • Change in caloric intake from post-intervention to follow-up. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    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. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).

  • Change in waist circumference from post-intervention to follow-up. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    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 post-intervention to follow-up. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    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 post-intervention to follow-up. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    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. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    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. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    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. [ Time Frame: follow-up (month 9) ] [ Designated as safety issue: No ]
    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. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
    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 [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
  • Change in total cholesterol from post-intervention to follow-up. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]
  • Change in triglycerides from post-intervention to follow-up. [ Time Frame: post-intervention (month 3), follow-up (month 9) ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Tailored Lifestyle Intervention (TLI)
The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.
Active Comparator: Commercial Weight Loss Program (CLWP)
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)
This intervention is a generic, widely-available weight management program.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630499

Contacts
Contact: Anne Mathews, PhD, RD 352-392-1991 ext 286 anne.mathews@ufl.edu
Contact: Samantha Ward, BS 352-403-8047 wardsamantha@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Anne Mathews, PhD, RD    352-392-1991 ext 286    anne.mathews@ufl.edu   
Contact: Samantha Ward, BS    352-403-8047    wardsamantha@ufl.edu   
Principal Investigator: Anne Mathews, PhD, RD         
University of North Florida Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Anne Mathews, PhD, RD    352-392-1991 ext 286    anne.mathews@ufl.edu   
Contact: Corinne Labyak, PhD, RD, LDN    352-403-8047    c.labyak@unf.edu   
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Anne Mathews, PhD, RD University of Florida
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01630499     History of Changes
Other Study ID Numbers: MyLIFE2012
Study First Received: June 22, 2012
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Cancer
Breast cancer
Breast cancer prevention
Breast cancer recurrence
Weight loss
Weight management
Overweight
Obesity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 08, 2014