My Lifestyle Intervention of Food and Exercise (MyLIFE)

September 28, 2016 updated by: University of Florida

Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • University of North Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight from baseline to post-intervention
Time Frame: baseline (month 0), post-intervention (month 3)
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)
post-intervention (month 3), follow-up (month 9)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
baseline (month 0), post-intervention (month 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
baseline (month 0), post-intervention (month 3)
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.
baseline (month 0), post-intervention (month 3)
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).
baseline (month 0), post-intervention (month 3)
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.
baseline (month 0), post-intervention (month 3)
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.
baseline (month 0), post-intervention (month 3)
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).
baseline (month 0), post-intervention (month 3)
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).
baseline (month 0), post-intervention (month 3)
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.
baseline (month 0), post-intervention (month 3)
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).
post-intervention (month 3)
Height
Time Frame: baseline (month 0)
Height will be assessed in order to determine BMI.
baseline (month 0)
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.
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)
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)
baseline (month 0), post-intervention (month 3)
Change in triglycerides from baseline to post-intervention.
Time Frame: baseline (month 0), post-intervention (month 3)
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)
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)
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)
post-intervention (month 3), follow-up (month 9)
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.
post-intervention (month 3), follow-up (month 9)
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).
post-intervention (month 3), follow-up (month 9)
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.
post-intervention (month 3), follow-up (month 9)
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.
post-intervention (month 3), follow-up (month 9)
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).
post-intervention (month 3), follow-up (month 9)
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).
post-intervention (month 3), follow-up (month 9)
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.
post-intervention (month 3), follow-up (month 9)
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).
follow-up (month 9)
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.
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)
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)
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)
post-intervention (month 3), follow-up (month 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Anne Mathews, PhD, RD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

June 22, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (ESTIMATE)

June 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyLIFE2012
  • 427-2012 (OTHER: UF IRB 01)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Tailored Lifestyle Intervention (TLI)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe