Intervention Program to Promote Changes in Diet and Physical Activity and to Evaluate Its Impact on Body Weight, Biomarkers of Disease and Quality of Life in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Bone Mineral Density
研究概览
简要总结
This study is a randomized controlled clinical trial of two arms, which included 60 women survivors of breast cancer of the state of Sonora, Mexico.The intervention is for 8 months and includes home visits every 15 days for the first four months and monthly for the last four months.The objective was to evaluate the effect of a diet and physical activity intervention program using the motivational interviewing (MI) strategy compared to an orientation with a traditional educational approach to improve anthropometric variables such as body weight, fat, muscle mass and bone mineral density, as well as biomarkers of the disease such as mammographic density, telomere length, telomerase activity, DNA methylation, ceramide-1-phosphate transport protein (CPTP), vascular endothelial growth factor (VEGF), C-reactive protein (CRP), interlucin 6 (IL-6) , interlucin 8 (IL-8), tumor necrosis factor alpha (TNF-α), leptin and adiponectin. Finally, the study also aims to improve psychological variables such as quality of life, sleep quality, anxiety and optimism.
详细描述
The overall objective was to design and implement an intervention program to promote changes in diet and physical activity that promotes, through the focus of the motivational interview, the increase in the consumption of fruits and vegetables, the decrease in the consumption of fats and the increase in physical activity, to achieve an impact in the reduction of weight and body fat, the improvement in the biomarkers of the disease and in the quality of life in women survivors of BC.
Specific objectives
- Determine the adherence of participants to a healthy lifestyle intervention by analyzing biological markers of dietary intake (alpha and beta carotene, as well as lipid profile) at the beginning of the study and at 4 and 8 months after initiation of the intervention.
- Investigate the impact of the intervention on changes in weight, body mass index, body fat, muscle mass and bone mineral density of women by measuring these variables at the beginning of the study and at 4 and 8 months after intervention.
- Examine the effect of the intervention on biomarkers of the disease: mammographic density, telomere length and telomerase activity, VEGF, DNA methylation and CPTP at baseline and 8 months.
- To evaluate the impact of the intervention program on inflammatory markers: leptin and adiponectin, IL6, IL8, CRP and TNF-α at the beginning, 4 and 8 months after the intervention started.
- Analyze the effect of the intervention on the alterations in sleep quality and quality of life of the women survivors of breast cancer at the beginning, 4 and 8 months after the intervention.
Study Design and Participants
This was a randomized controlled clinical trial with two groups of breast cancer survivors. In the intervention group, we used the strategy of Motivational Interviewing to promote changes in diet and physical activity; the comparison group received an orientation with a traditional educational approach. The intervention program lasted eight months. A total of 60 women from Sonora, Mexico, participated in the study. The women were selected from the State Oncology Center and through social networks. The research protocol was sent to the ethics committee of the Center for Research in Food and Development, A.C. and women signed an informed consent letter to participate in the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 73 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 18 with a diagnosis of stage II-IV invasive breast cancer
- •Have at least 6 weeks and no more than 2 years of completing your therapy at the time of recruitment
- •Do not present metastasis
- •Not having a special diet or rigorous physical activity
- •Not suffer any chronic illness or physical limitation
- •Not have depression problems
- •Sign the informed consent letter
- •Exclusion Criteria
- •Have restrictions for physical activity
- •Strict diet or be a vegetarian
- •Body mass index below 18
- •Having undergone surgery to lose weight
- •Having excision in both breasts or having implants
排除标准
- 未提供
研究组 & 干预措施
Motivational Interviewing
The intervention group received a guidance regarding their diet and physical activity using the motivational interviewing strategy to improve adherence to healthy behaviors. Participants received a guide with a motivational interviewing approach, which served as the basis for the interview process. The objectives in the intervention group were to consume four vegetables and two fruits a day, seven days a week, increase fiber consumption to more than 30 g daily, reduce fat consumption to no more 20% of the total energy consumed, decrease the consumption of sugary drinks and increase protein intake. Another goal was to increase the number of steps to 4,000 additional steps to those who have already walked.
干预措施: Motivational Interviewing (Behavioral)
Traditional Education
The comparison group received a guide on medical care and nutrition with a traditional educational approach. The indication was to read and learn about the health-related topics included in the booklet that was given to them. These participants were visited in the same way as the intervention group to answer questions and monitor participation throughout the intervention.
干预措施: Traditional Education (Behavioral)
结局指标
主要结局
Change in Bone Mineral Density
时间窗: baseline, at four months and eight months
The amount of bone mineral in bone tissue in g/cm2
Change in Quality life
时间窗: baseline, at four months and eight months
Change in score of the scale of the Quality of Life Patient/Cancer Survivor Version. questionnaire carried out by Ferrell et al., (2012). This questionnaire analyzes the dimensions of physical, emotional, social, and spiritual well-being through a Likert scale. The minimum score to be obtained is 42 and the maximum score is 210 points, where the higher the score, the better the quality of life and the lower the score, the worse the quality of life.
Change in Sleep Quality
时间窗: baseline, at four months and eight months
Change in score of the scale of the Pittsburgh Sleep Quality Index. This questionnaire uses a Likert-type scale and provides an overall score of the quality of sleep in a range of 0 to 21, where the highest score refers to greater difficulties in all areas of sleep and a lower score gives a better sleep quality
Change in Body Weight
时间窗: baseline, at four months and eight months
Change in body weight in kilograms
Change in Breast Density
时间窗: baseline and at eight months
Change in the amount of dense tissue compared to the amount of fatty tissue in the breast on a mammogram reported in percentage
Change in telomere length
时间窗: baseline and at eight months
Absolute telomere length (kilobase pair) (kbp)
次要结局
- Change in interleukin 8 levels(baseline and at eight months)
- Change in adiponectin levels(baseline and at eight months)
- Change in the activity of telomerase(baseline and at eight months)
- Change in interleukin 6 levels(baseline and at eight months)
- Change in percentage of muscle mass(baseline, at four months and eight months)
- Change in C-reactive protein levels(baseline and at eight months)
- Change in levels of tumor necrosis factor alpha(baseline and at eight months)
- Change in leptin levels(baseline and at eight months)
- Change in vascular endothelial growth factor levels(baseline and at eight months)
- Change in the percentage of fat mass(baseline, at four months and eight months)
- change in the optimism scale(baseline, at four months and eight months)
- change in the anxiety scale(baseline, at four months and eight months)
研究者
Graciela Caire Juvera, PhD
PhD
Centro de Investigación en Alimentación y Desarrollo A.C.