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My Lifestyle Intervention of Food and Exercise (MyLIFE)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Lifestyle Intervention (TLI)
Commercial Weight Loss Program (CWLP)
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Cancer, Breast cancer, Breast cancer prevention, Breast cancer recurrence, Weight loss, Weight management, Overweight, Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida
  • University of North Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tailored Lifestyle Intervention (TLI)

Commercial Weight Loss Program (CLWP)

Arm Description

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.

Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost.

Outcomes

Primary Outcome Measures

Change in body weight from baseline to post-intervention
Change in body weight from post-intervention to follow-up

Secondary Outcome Measures

Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention
Change in HDL Cholesterol from baseline to post-intervention
Change in blood glucose control from baseline to post-intervention.
HgA1c and fasting glucose to assess blood glucose control
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.
Change in body composition from baseline to post-intervention.
Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).
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.
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.
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).
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).
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.
Use of weight management strategies
The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).
Height
Height will be assessed in order to determine BMI.
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.
Change in LDL cholesterol at from baseline to post-intervention.
Change in total cholesterol from baseline to post-intervention.
Change in triglycerides from baseline to post-intervention.
Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up.
Change in HDL Cholesterol from post-intervention to follow-up.
Change in blood glucose control from post-intervention to follow-up.
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.
Change in body composition from post-intervention to follow-up.
Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).
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.
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.
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).
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).
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.
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).
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.
Change in LDL cholesterol at from post-intervention follow-up
Change in total cholesterol from post-intervention to follow-up.
Change in triglycerides from post-intervention to follow-up.

Full Information

First Posted
June 22, 2012
Last Updated
September 28, 2016
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01630499
Brief Title
My Lifestyle Intervention of Food and Exercise
Acronym
MyLIFE
Official Title
Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cancer, Breast cancer, Breast cancer prevention, Breast cancer recurrence, Weight loss, Weight management, Overweight, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Lifestyle Intervention (TLI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Commercial Weight Loss Program (CLWP)
Arm Type
Active Comparator
Arm Description
Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Lifestyle Intervention (TLI)
Intervention Description
The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.
Intervention Type
Behavioral
Intervention Name(s)
Commercial Weight Loss Program (CWLP)
Intervention Description
This intervention is a generic, widely-available weight management program.
Primary Outcome Measure Information:
Title
Change in body weight from baseline to post-intervention
Time Frame
baseline (month 0), post-intervention (month 3)
Title
Change in body weight from post-intervention to follow-up
Time Frame
post-intervention (month 3), follow-up (month 9)
Secondary Outcome Measure Information:
Title
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)
Title
Change in HDL Cholesterol from baseline to post-intervention
Time Frame
baseline (month 0), post-intervention (month 3)
Title
Change in blood glucose control from baseline to post-intervention.
Description
HgA1c and fasting glucose to assess blood glucose control
Time Frame
baseline (month 0), post-intervention (month 3)
Title
Change in caloric intake from baseline to post-intervention.
Description
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)
Title
Change in body composition from baseline to post-intervention.
Description
Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).
Time Frame
baseline (month 0), post-intervention (month 3)
Title
Change in waist circumference from baseline to post-intervention.
Description
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)
Title
Change in sagittal abdominal diameter from baseline to post-intervention.
Description
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)
Title
Change in physical activity from baseline to post-intervention.
Description
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)
Title
Change in health-related quality of life from baseline to post-intervention.
Description
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)
Title
Change in self-efficacy from baseline to post-intervention.
Description
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)
Title
Use of weight management strategies
Description
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)
Title
Height
Description
Height will be assessed in order to determine BMI.
Time Frame
baseline (month 0)
Title
Change in blood pressure from baseline to post-intervention.
Description
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)
Title
Change in LDL cholesterol at from baseline to post-intervention.
Time Frame
baseline (month 0), post-intervention (month 3)
Title
Change in total cholesterol from baseline to post-intervention.
Time Frame
baseline (month 0), post-intervention (month 3)
Title
Change in triglycerides from baseline to post-intervention.
Time Frame
baseline (month 0), post-intervention (month 3)
Title
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)
Title
Change in HDL Cholesterol from post-intervention to follow-up.
Time Frame
post-intervention (month 3), follow-up (month 9)
Title
Change in blood glucose control from post-intervention to follow-up.
Time Frame
post-intervention (month 3), follow-up (month 9)
Title
Change in caloric intake from post-intervention to follow-up.
Description
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)
Title
Change in body composition from post-intervention to follow-up.
Description
Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).
Time Frame
post-intervention (month 3), follow-up (month 9)
Title
Change in waist circumference from post-intervention to follow-up.
Description
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)
Title
Change in sagittal abdominal diameter from post-intervention to follow-up.
Description
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)
Title
Change in physical activity from post-intervention to follow-up.
Description
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)
Title
Change in health-related quality of life from post-intervention to follow-up.
Description
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)
Title
Change in self-efficacy from post-intervention to follow-up.
Description
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)
Title
Use of weight management strategies at follow-up.
Description
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)
Title
Change in blood pressure from post-intervention to follow-up.
Description
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)
Title
Change in LDL cholesterol at from post-intervention follow-up
Time Frame
post-intervention (month 3), follow-up (month 9)
Title
Change in total cholesterol from post-intervention to follow-up.
Time Frame
post-intervention (month 3), follow-up (month 9)
Title
Change in triglycerides from post-intervention to follow-up.
Time Frame
post-intervention (month 3), follow-up (month 9)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Mathews, PhD, RD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

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