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Completed

NCT Number: NCT01630499

My Lifestyle Intervention of Food and Exercise

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.

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Key information

Conditions

Breast Cancer Body Weight Body Weight Changes Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Weight Loss

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in body weight from baseline to post-intervention

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

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

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

Secondary outcomes

  1. 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)

  2. Change in HDL Cholesterol from baseline to post-intervention

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

  3. Change in blood glucose control from baseline to post-intervention.

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

    HgA1c and fasting glucose to assess blood glucose control

  4. Change in caloric intake from baseline to post-intervention.

    Time frame: 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.

  5. Change in body composition from baseline to post-intervention.

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

    Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).

  6. Change in waist circumference from baseline to post-intervention.

    Time frame: 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.

  7. Change in sagittal abdominal diameter from baseline to post-intervention.

    Time frame: 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.

  8. Change in physical activity from baseline to post-intervention.

    Time frame: 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).

  9. Change in health-related quality of life from baseline to post-intervention.

    Time frame: 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).

  10. Change in self-efficacy from baseline to post-intervention.

    Time frame: 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.

  11. Use of weight management strategies

    Time frame: post-intervention (month 3)

    The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).

  12. Height

    Time frame: baseline (month 0)

    Height will be assessed in order to determine BMI.

  13. Change in blood pressure from baseline to post-intervention.

    Time frame: 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.

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

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

  15. Change in total cholesterol from baseline to post-intervention.

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

  16. Change in triglycerides from baseline to post-intervention.

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

  17. 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)

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

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

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

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

  20. Change in caloric intake from post-intervention to follow-up.

    Time frame: 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.

  21. Change in body composition from post-intervention to follow-up.

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

    Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).

  22. Change in waist circumference from post-intervention to follow-up.

    Time frame: 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.

  23. Change in sagittal abdominal diameter from post-intervention to follow-up.

    Time frame: 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.

  24. Change in physical activity from post-intervention to follow-up.

    Time frame: 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).

  25. Change in health-related quality of life from post-intervention to follow-up.

    Time frame: 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).

  26. Change in self-efficacy from post-intervention to follow-up.

    Time frame: 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.

  27. Use of weight management strategies at follow-up.

    Time frame: follow-up (month 9)

    The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).

  28. Change in blood pressure from post-intervention to follow-up.

    Time frame: 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.

  29. Change in LDL cholesterol at from post-intervention follow-up

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

  30. Change in total cholesterol from post-intervention to follow-up.

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

  31. Change in triglycerides from post-intervention to follow-up.

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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

Acronym: MyLIFE

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2012
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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