Clinical trial · Interventional
My Lifestyle Intervention of Food and Exercise
Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Commercial Weight Loss Program (CWLP) | Behavioral | — | UNRESOLVED |
| Tailored Lifestyle Intervention (TLI) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tailored Lifestyle Intervention (TLI)
- 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.
- interventionNames
- Behavioral: Tailored Lifestyle Intervention (TLI)
- type
- ACTIVE_COMPARATOR
- label
- Commercial Weight Loss Program (CLWP)
- description
- Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost.
- interventionNames
- Behavioral: Commercial Weight Loss Program (CWLP)
Primary outcomes (2)
- measure
- Change in body weight from baseline to post-intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (16)
- BACKGROUNDPharoah 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
- BACKGROUNDMcTiernan 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
- BACKGROUNDKing 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
- BACKGROUNDCalle 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
- BACKGROUNDBerclaz 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
- BACKGROUNDNichols 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
- BACKGROUNDGallicchio 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.