Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Physiological indicator II
研究概览
简要总结
The study addresses the pressing issue of overweight and obesity among breast cancer patients, which exacerbates recurrence rates and mortality risks. Its primary objective is to assess the efficacy of two intervention models, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, in facilitating weight loss, enhancing self-efficacy, mindfulness, and quality of life. The anticipated outcomes include long-term engagement in online self-learning, overcoming the limitations of ineffective self-management learning, and empowering healthcare professionals with scenario-based teaching materials. Through online platforms, patients can learn and review without constraints, ultimately achieving a holistic balance among physical, mental, and spiritual health.
详细描述
[Research Background] Breast cancer ranks first among cancers in women worldwide, with overweight and obesity being one of the high-risk factors for breast cancer. Moreover, overweight individuals within the breast cancer patient population also face higher recurrence rates and mortality risks. Assisting overweight or obese breast cancer women in weight loss to promote their well-being was the initial idea behind this study. The most common weight loss strategies include dietary management and regular exercise. In recent years, more studies have shown that effective weight loss also requires psychological interventions. Therefore, this study will combine dietary, exercise, and mindfulness-related interventions to assist breast cancer patients in more effective weight management.
[Research Objectives] To compare the effectiveness of two intervention measures, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, on weight loss, self-efficacy, mindfulness tendency, and quality of life.
[Research Method] The study will involve a quantitative study, which plans to carry out a randomized controlled trial (RCT). This trial will compare the effects of two intervention measures, the DEM model and the DE model, on weight loss, self-efficacy, mindfulness tendency, and quality of life.
[Expected Results] Through the intervention provided by this study, patients can engage in long-term online self-learning and supplementary learning after returning home, reducing the limitations of ineffective self-management learning caused by negative emotions, treatment side effects, and sequelae in the early stages of cancer. Healthcare professionals can also use scenario-based teaching materials produced by this study to guide breast cancer survivors with ineffective weight self-management skills in practicing the necessary skills. Additionally, through online learning, patients can learn and review without pressure, saving time on transportation, easing carbon foot print and relearning effective weight management skills; even if they have faced major life threats in the past, they can turn adversity into blessings, achieving a balance among physical, mental, and spiritual health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •stage I-III breast cancer and completed treatment
- •Body mass index (BMI) is greater than or equal to 24 kg/m2
- •possess a smartphone
排除标准
- •Pregnant or planning to become pregnant within six months
- •Those who are unable to walk
结局指标
主要结局
Physiological indicator II
时间窗: baseline, 8 weeks, 24 weeks, 48 weeks
Waist circumference in centimeter
Food Intake Frequency
时间窗: baseline, 8 weeks, 24 weeks, 48 weeks
Food Frequency Questionnaire
Physiological indicator I
时间窗: baseline, 8 weeks, 24 weeks, 48 weeks
BMI in kg/m2 (weight in kilograms divided by height in meters squared)
Physiological indicator IV
时间窗: baseline, 8 weeks, 24 weeks, 48 weeks
Muscle mass in kilograms
Mindful Awareness Attention
时间窗: baseline, 8 weeks, 24 weeks, 48 weeks
The minimum value is 1 and maximum value is 6, and higher scores mean a better outcome.
Physiological indicator III
时间窗: baseline, 8 weeks, 24 weeks, 48 weeks
Body fat in percentage
次要结局
- Breast Cancer-Specific Quality of Life Questionnaire(baseline, 8 weeks, 24 weeks, 48 weeks)
- Weight Efficacy Lifestyle Questionnaire(baseline, 8 weeks, 24 weeks, 48 weeks)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(baseline, 8 weeks, 24 weeks, 48 weeks)
研究者
I-Ching Hou
Associate Professor
National Yang Ming Chiao Tung University
