Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Adherence to supervised exercise sessions
研究概览
简要总结
The purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..
详细描述
Feasibility will be assessed by 1) the number of women that complete the 3--month program; 2) the number of women that can achieve the targeted amount of physical activity per week by the end of the program; and 3) the median amount of physical activity achieved group by all subjects that complete the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 71 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women < age 71 in good general health.
- •Prior diagnosis of breast cancer.
- •At least 3 months from completion of any cytotoxic chemotherapy or radiation or surgery. May continue to take endocrine therapy and/or maintenance trastuzumab.
- •Body Mass Index (BMI) 30-45 kg/m
- •By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface.
- •Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel.
- •Live in the greater Kansas City Metropolitan Area
- •Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months.
- •Willing to perform unsupervised home exercise for the entire 3 months.
- •Willing to participate in a weekly behavioral modification group phone call for 3 months.
- •Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal and track food intake and exercise.
排除标准
- •Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks
- •Individuals with prior bariatric surgery procedures
- •Need for chronic immunosuppressive drugs
- •Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
- •Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
- •Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event.
- •Currently receiving investigational agents in a clinical trial.
研究组 & 干预措施
Weight Loss Intervention Group
Participants will take part in supervised exercise and home-based exercise sessions. Participants will be asked to follow a specific diet. Participants will be asked to take part in weekly behavioral group phone calls.
干预措施: Supervised Exercise (Behavioral)
Weight Loss Intervention Group
Participants will take part in supervised exercise and home-based exercise sessions. Participants will be asked to follow a specific diet. Participants will be asked to take part in weekly behavioral group phone calls.
干预措施: Home-based Exercise (Behavioral)
Weight Loss Intervention Group
Participants will take part in supervised exercise and home-based exercise sessions. Participants will be asked to follow a specific diet. Participants will be asked to take part in weekly behavioral group phone calls.
干预措施: Group Phone Calls (Behavioral)
Weight Loss Intervention Group
Participants will take part in supervised exercise and home-based exercise sessions. Participants will be asked to follow a specific diet. Participants will be asked to take part in weekly behavioral group phone calls.
干预措施: Diet (Behavioral)
结局指标
主要结局
Adherence to supervised exercise sessions
时间窗: Week 12
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
次要结局
- Compliance with group telephone sessions(Week 12)
- Percent participants meeting physical activity goal(Week 9 to Week 12)
研究者
Carol Fabian, MD
Professor, Director Breast Cancer Prevention Unit
University of Kansas Medical Center