My Lifestyle Intervention of Food and Exercise

NCT01630499 | Completed

• 2 other identifiers: MyLIFE2012427-2012
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Cancer; Breast cancer; Breast cancer prevention; Breast cancer recurrence; Weight loss; Weight management; Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Change in body weight from baseline to post-intervention

  baseline (month 0), post-intervention (month 3)

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

  post-intervention (month 3), follow-up (month 9)

Secondary Outcomes (31)

• Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention

  baseline (month 0), post-intervention (month 3)

• Change in HDL Cholesterol from baseline to post-intervention

  baseline (month 0), post-intervention (month 3)

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

  baseline (month 0), post-intervention (month 3)

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

  baseline (month 0), post-intervention (month 3)

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

  baseline (month 0), post-intervention (month 3)

Study Arms (2)

Tailored Lifestyle Intervention (TLI)

EXPERIMENTAL

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)

Commercial Weight Loss Program (CLWP)

ACTIVE COMPARATOR

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)

Interventions

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.

Tailored Lifestyle Intervention (TLI)

Commercial Weight Loss Program (CWLP) BEHAVIORAL

This intervention is a generic, widely-available weight management program.

Commercial Weight Loss Program (CLWP)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• At-rest blood pressure \> 140/90 mg/Hg
• Myocardial infarction
• Stroke
• Congestive heart failure
• Chronic hepatitis
• Cirrhosis
• Chronic pancreatitis

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of North Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (16)

• Pharoah PD, Day NE, Duffy S, Easton DF, Ponder BA. Family history and the risk of breast cancer: a systematic review and meta-analysis. Int J Cancer. 1997 May 29;71(5):800-9. doi: 10.1002/(sici)1097-0215(19970529)71:53.0.co;2-b.

  PMID: 9180149 BACKGROUND

• McTiernan A. Behavioral risk factors in breast cancer: can risk be modified? Oncologist. 2003;8(4):326-34. doi: 10.1634/theoncologist.8-4-326.

  PMID: 12897329 BACKGROUND

• King MC, Marks JH, Mandell JB; New York Breast Cancer Study Group. Breast and ovarian cancer risks due to inherited mutations in BRCA1 and BRCA2. Science. 2003 Oct 24;302(5645):643-6. doi: 10.1126/science.1088759.

  PMID: 14576434 BACKGROUND

• Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.

  PMID: 12711737 BACKGROUND

• Berclaz G, Li S, Price KN, Coates AS, Castiglione-Gertsch M, Rudenstam CM, Holmberg SB, Lindtner J, Erien D, Collins J, Snyder R, Thurlimann B, Fey MF, Mendiola C, Werner ID, Simoncini E, Crivellari D, Gelber RD, Goldhirsch A; International Breast Cancer Study Group. Body mass index as a prognostic feature in operable breast cancer: the International Breast Cancer Study Group experience. Ann Oncol. 2004 Jun;15(6):875-84. doi: 10.1093/annonc/mdh222.

  PMID: 15151943 BACKGROUND

• Nichols HB, Trentham-Dietz A, Egan KM, Titus-Ernstoff L, Holmes MD, Bersch AJ, Holick CN, Hampton JM, Stampfer MJ, Willett WC, Newcomb PA. Body mass index before and after breast cancer diagnosis: associations with all-cause, breast cancer, and cardiovascular disease mortality. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1403-9. doi: 10.1158/1055-9965.EPI-08-1094. Epub 2009 Apr 14.

  PMID: 19366908 BACKGROUND

• Gallicchio L, Kalesan B, Hoffman SC, Helzlsouer KJ. Non-cancer adverse health conditions and perceived health and function among cancer survivors participating in a community-based cohort study in Washington County, Maryland. J Cancer Surviv. 2008 Mar;2(1):12-9. doi: 10.1007/s11764-008-0046-1. Epub 2008 Feb 12.

  PMID: 18648983 BACKGROUND

• Fossa SD, Vassilopoulou-Sellin R, Dahl AA. Long term physical sequelae after adult-onset cancer. J Cancer Surviv. 2008 Mar;2(1):3-11. doi: 10.1007/s11764-007-0039-5. Epub 2007 Dec 4.

  PMID: 18648982 BACKGROUND

• Chen Z, Maricic M, Bassford TL, Pettinger M, Ritenbaugh C, Lopez AM, Barad DH, Gass M, Leboff MS. Fracture risk among breast cancer survivors: results from the Women's Health Initiative Observational Study. Arch Intern Med. 2005 Mar 14;165(5):552-8. doi: 10.1001/archinte.165.5.552.

  PMID: 15767532 BACKGROUND

• Coups EJ, Ostroff JS. A population-based estimate of the prevalence of behavioral risk factors among adult cancer survivors and noncancer controls. Prev Med. 2005 Jun;40(6):702-11. doi: 10.1016/j.ypmed.2004.09.011.

  PMID: 15850868 BACKGROUND

• Bellizzi KM, Rowland JH, Jeffery DD, McNeel T. Health behaviors of cancer survivors: examining opportunities for cancer control intervention. J Clin Oncol. 2005 Dec 1;23(34):8884-93. doi: 10.1200/JCO.2005.02.2343.

  PMID: 16314649 BACKGROUND

• Robien K, Demark-Wahnefried W, Rock CL. Evidence-based nutrition guidelines for cancer survivors: current guidelines, knowledge gaps, and future research directions. J Am Diet Assoc. 2011 Mar;111(3):368-75. doi: 10.1016/j.jada.2010.11.014. No abstract available.

  PMID: 21338735 BACKGROUND

• Coussens LM, Werb Z. Inflammation and cancer. Nature. 2002 Dec 19-26;420(6917):860-7. doi: 10.1038/nature01322.

  PMID: 12490959 BACKGROUND

• Shacter E, Weitzman SA. Chronic inflammation and cancer. Oncology (Williston Park). 2002 Feb;16(2):217-26, 229; discussion 230-2.

  PMID: 11866137 BACKGROUND

• Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.

  PMID: 20071471 BACKGROUND

• Vance V, Mourtzakis M, McCargar L, Hanning R. Weight gain in breast cancer survivors: prevalence, pattern and health consequences. Obes Rev. 2011 Apr;12(4):282-94. doi: 10.1111/j.1467-789X.2010.00805.x. Epub 2010 Sep 29.

  PMID: 20880127 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Weight Loss; Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne Mathews, PhD, RD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 28, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2016-09

Locations

US (2)