NCT01630499已完成不适用
Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Change in body weight from baseline to post-intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Tailored Lifestyle Intervention (TLI) (Behavioral)
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.
干预措施: Commercial Weight Loss Program (CWLP) (Behavioral)
结局指标
主要结局
Change in body weight from baseline to post-intervention
时间窗: baseline (month 0), post-intervention (month 3)
Change in body weight from post-intervention to follow-up
时间窗: post-intervention (month 3), follow-up (month 9)
次要结局
- 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))
- Change in waist circumference from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
- Change in sagittal abdominal diameter from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
- Change in physical activity from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
- Change in health-related quality of life from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
- Change in self-efficacy from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
- Use of weight management strategies(post-intervention (month 3))
- Height(baseline (month 0))
- Change in blood pressure from baseline to post-intervention.(post-intervention (month 3), follow-up (month 9))
- Change in LDL cholesterol at from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
- Change in total cholesterol from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
- Change in triglycerides from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
- Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in HDL Cholesterol from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in blood glucose control from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in caloric intake from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in body composition from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in waist circumference from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in sagittal abdominal diameter from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in physical activity from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in health-related quality of life from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in self-efficacy from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Use of weight management strategies at follow-up.(follow-up (month 9))
- Change in blood pressure from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in LDL cholesterol at from post-intervention follow-up(post-intervention (month 3), follow-up (month 9))
- Change in total cholesterol from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
- Change in triglycerides from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
研究者
研究点 (2)
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