Clinical trial · Interventional
Effect of a Low-Calorie Diet and/or Exercise Program on Risk Factors for Developing Breast Cancer in Overweight or Obese Postmenopausal Women
Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
NCT00470119CI-TRIAL-00007999completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer. PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.
Conditions
Conditions (3)
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 |
| Obesity | — | UNRESOLVED | — |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral dietary intervention | Behavioral | — | UNRESOLVED |
| Exercise intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Control
- type
- OTHER
- label
- Caloric Restriction
- description
- Nutritionist-delivered weight loss intervention though diet modification with an aim of 10% weightloss over a year long intervention based on the DPP and LookAHEAD interventions. Participants meet with a nutritionist individually and in small groups. Participants receive general information about diet and behavior strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and relapse-prevention training. Participants learn to set a calorie goal and a fat gram goal and how to achieve the goal calorie reduction. Meetings are held weekly during the first 6 months of the diet program but taper off over the course of the study.
- interventionNames
- Behavioral: behavioral dietary intervention
- type
- OTHER
- label
- Exercise Intervention
- description
- Participants exercise 3 days per week under the supervision of a physiologist and 2 days per week independently at home, for a total of 5 exercise sessions (at least 45 minutes of moderate-intensity exercise per session) weekly over 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * At increased risk for developing breast cancer due to any of the following lifestyle risk factors: * Lack of physical activity * Excess weight * Obesity * Weight gain over lifetime * Body mass index \> 25.0 * Physically able to undertake a moderate exercise or calorie reduction program * No history of invasive or in situ breast cancer PATIENT CHARACTERISTICS: * Postmenopausal, defined by the absence of periods for the past 12 months * Able to attend study clinic visits and classes, and undergo study measurements * Able to fill out questionnaires and logs in English * No moderate to high alcohol intake (more than 2 drinks per day) * No concurrent smoking * No invasive cancer within the past 10 years except simple basal cell or squamous cell carcinoma * No diabetes mellitus * Fasting blood sugar \< 126 mg/dL (on 2 occasions) * Hematocrit 32-48% * WBC 3,000-15,000/mm³ * Potassium 3.5-5.0 mEq/L * Creatinine ≤ 2.0 mg/dL * No abnormalities on screening physical that contraindicate study participation * No contraindications for treadmill testing or entry into a training program, including any of the following: * Myocardial infarction within the past 6 months * Pulmonary edema * Myocarditis * Pericarditis * Unstable angina * Pulmonary embolism or deep vein thrombosis * Uncontrolled hypertension (i.e., blood pressure \> 200/100 mm Hg) * Orthostatic hypotension * Moderate-to-severe aortic stenosis * Uncontrolled arrhythmia * Uncontrolled congestive heart failure * Third-degree heart block * Left bundle branch block * Thrombophlebitis * ST depression \> 3 mm at rest * History of cardiac arrest or stroke * Normal exercise treadmill testing (ETT) * Negative thallium or echo ETT required for patients with abnormal ETT (defined as ≥ 1.5 mm ST depression in \> 1 lead within 1-minute recovery OR ≥ 1.1 mm ST depression in \> 1 lead after 1-minute recovery OR reading of positive test by study doctor) * No drug abuse * No significant mental illness PRIOR CONCURRENT THERAPY: * More than 6 months since prior and no concurrent menopausal hormone replacement therapy of any type, including vaginal route * No concurrent participation in any other organized weight loss or exercise program * No concurrent appetite suppressant medication * No concurrent medications (e.g., weight-loss medications) likely to interfere with adherence to interventions or study outcomes
References
Publications (10)
- DERIVEDDuggan C, Tapsoba JD, Shivappa N, Harris HR, Hebert JR, Wang CY, McTiernan A. Changes in Dietary Inflammatory Index Patterns with Weight Loss in Women: A Randomized Controlled Trial. Cancer Prev Res (Phila). 2021 Jan;14(1):85-94. doi: 10.1158/1940-6207.CAPR-20-0181. Epub 2020 Aug 28. PMID 32859616
- DERIVEDMason C, de Dieu Tapsoba J, Duggan C, Wang CY, Alfano CM, McTiernan A. Eating behaviors and weight loss outcomes in a 12-month randomized trial of diet and/or exercise intervention in postmenopausal women. Int J Behav Nutr Phys Act. 2019 Nov 27;16(1):113. doi: 10.1186/s12966-019-0887-1. PMID 31775800
- DERIVEDDuggan C, Tapsoba Jde D, Wang CY, McTiernan A. Dietary Weight Loss and Exercise Effects on Serum Biomarkers of Angiogenesis in Overweight Postmenopausal Women: A Randomized Controlled Trial. Cancer Res. 2016 Jul 15;76(14):4226-35. doi: 10.1158/0008-5472.CAN-16-0399. PMID 27417562
- DERIVEDHabermann N, Makar KW, Abbenhardt C, Xiao L, Wang CY, Utsugi HK, Alfano CM, Campbell KL, Duggan C, Foster-Schubert KE, Mason CE, Imayama I, Blackburn GL, Potter JD, McTiernan A, Ulrich CM. No effect of caloric restriction or exercise on radiation repair capacity. Med Sci Sports Exerc. 2015 May;47(5):896-904. doi: 10.1249/MSS.0000000000000480. PMID 25160845
- DERIVEDDuggan C, Xiao L, Terry MB, McTiernan A. No effect of weight loss on LINE-1 methylation levels in peripheral blood leukocytes from postmenopausal overweight women. Obesity (Silver Spring). 2014 Sep;22(9):2091-6. doi: 10.1002/oby.20806. Epub 2014 Jun 13. PMID 24930817
- DERIVEDImayama I, Alfano CM, Mason C, Wang C, Duggan C, Campbell KL, Kong A, Foster-Schubert KE, Blackburn GL, Wang CY, McTiernan A. Weight and metabolic effects of dietary weight loss and exercise interventions in postmenopausal antidepressant medication users and non-users: a randomized controlled trial. Prev Med. 2013 Nov;57(5):525-32. doi: 10.1016/j.ypmed.2013.07.006. Epub 2013 Jul 13.