Cancer Survival Through Weight Loss and Exercise (CASTLE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.
详细描述
This study will be divided into two phases (Phase I and II) that will differ by the intensity of motivational intervention. In Phase I, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. Phase II will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. Participants will then be assigned to either the group based intervention or telephone intervention. The first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II (week 50). Up to 60 women with a previous history of breast cancer will participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 30 and
- •Positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization.
- •BMI ≥ 25 kg/m2 and ≤ 45 kg/m2
- •Not involved in regular physical activity or weight loss management programs.
- •Stage I, II or IIIa breast cancer with good prognosis.
排除标准
- •Presence of any co-morbidities including cardiovascular disease or diabetes
- •Fasting triglycerides > 500 mg/dl.
- •Consume more than 14 alcoholic beverages per week.
- •A history of drug abuse, or excess alcohol consumption (40g/day)
- •Currently dieting or engaging in any activity with the goal of losing weight.
- •Significant intentional weight loss in the past year (> 50 lbs in the past year) or current use of weight loss medications.
- •History of gastrointestinal bypass or other bariatric surgery in the last 3 years.
- •Pregnant or plan on becoming pregnant in the next 12 months.
- •Factors that may limit adherence to intervention or affect conduct of the trial.
- •Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
- •Failure to complete run-in and baseline testing.
- •Lack support from health care provider or family members.
- •Other temporary intervening event, such as sick spouse, bereavement, or recent move.
- •Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
- •Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
- •Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.
研究组 & 干预措施
Group-based Intervention
We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity.
干预措施: Group-based Intervention (Behavioral)
Telephone-based Intervention
We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity.
干预措施: Telephone-based Intervention (Behavioral)
结局指标
主要结局
Weight loss
时间窗: 1 year
To examine the effectiveness of using motivational, behavioral interventions aimed at improving physical activity levels and dietary habits to produce weight loss in women with a history of breast cancer.
次要结局
- Feasibility of recruiting breast cancer survivors(1 year)
- Examination of health outcomes, breast cancer reoccurrence, and mortality.(1 year)