Development of a Methodology for Diagnosis and Promoting Adherence to Treatment of Patients With Chronic Diseases and Evaluation of Their Impact on Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia)
研究概览
简要总结
The metabolic syndrome is a group of cardiometabolic risk factors that reflect a sedentary lifestyle and the excessive intake of food among the risk factors that comprise it are located the obesity, hyperglycemia, dyslipidemia and hypertension.
It has been observed that the interventions of lifestyle changes that promote weight loss through the practice of physical activity and intake of a hypocaloric diet, reduce the prevalence of chronic diseases such as Metabolic syndrome.
Adherence is defined as the extent to which a person's behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. The World Health Organization has estimated that in developing countries, as in Mexico, less than 27% of people with chronic diseases will continue treatment as directed.
Adherence to treatment of chronic disease is a multifactorial problem that includes not only patient-related barriers, but also providers of health services and social security systems themselves. Furthermore, as WHO has pointed out, as increasing prevalence of chronic non-adherence to treatment will become a global problem even more serious.
The purpose of this study is develop and implement a methodology to overcome barriers affecting adherence to treatment of women over 20 years with non-communicable diseases such as metabolic syndrome (diabetes , hypertension and dyslipidemia) evaluating its impact through various quantitative indicators such as weight loss or metabolic syndrome prevalence.
This study will include two phases:
- Phase 1. Design. Qualitative methodology was used primarily to identify the barriers faced by individuals to adhere to treatment. From this methodology, we developed a tool to assess adherence to treatment of subjects with these conditions and then an intervention to improve it.
- Phase 2. Implementation of intervention (24 weeks). To recruite a group of 180 overweight and two of the following comorbidities: diabetes mellitus, dyslipidemia or hypertension. All study subjects will be randomized to a control group and intervention. The control group will receive a medical traditional clinical care. The intervention group will receive a lifestyle treatment with behavioral intervention to improve adherence for improve eating behaviors, physical activity and metabolic control.
详细描述
The World Health Organization estimates that worldwide one billion adults are overweight. In Mexico, the prevalence of overweight and obesity using data from 2006 was nearly 70% in men and women over 20 years.
Being overweight is associated with other co-morbidities such as diabetes mellitus (79.4%), hypertension (78.0%) and dyslipidemia (82.8%). WHO has estimated that over 50% of these patients have a poor grip and do not follow their treatment as indicated, generating costs for managing these diseases of until $ 100 billion each year. Improve the effectiveness of interventions on adherence to treatment, will significantly improve the health of these patients and help reduce costs involving health systems.
The obesity and comorbidities affect 41% of the adults in Mexico and increases up to five times the risk of developing cardiovascular disease and type 2 diabetes and up to three times the risk of developing coronary artery disease and myocardial infarction. Therefore, these diseases are currently one of the main problems of public health in Mexico.
Adherence to short and long term is the result of a complex process that develops through different stages: the acceptance of diagnosis, the perceived need for treatment successfully, motivation, and skills training available, the ability to overcome the barriers or difficulties arise, and maintenance of achievements over time.
The lack of adherence to chronic disease is a multifactorial problem that includes not only patient-related barriers, but also with service providers and health systems. Poor adherence to long-term therapies severely compromises the effectiveness of treatment and negatively impacts the quality of life of patients.
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
- None
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
- •Women from 19 to 65 years old
- •Body mass index ≥ 25.0 - ≤39.9 or abdominal obesity
- •With previous medical diagnosis:
- •high fasting glucose
- •high blood pressure
- •dyslipidemia.
排除标准
- •Currently pregnant or breast-feeding.
- •Anxiety and depression significantly.
- •Consumption of alcohol or smoking significantly.
- •Taking anorexigenic or other weight-loss drugs (Xenical)
- •Pregnant or breastfeeding
- •Have polycystic ovary syndrome,
- •Kidney failure
- •Hypothyroidism,
- •Anxiety or depression
结局指标
主要结局
Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia)
时间窗: 24 weeks
To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
次要结局
- Weight loss(24 weeks)
- Reduction of high blood pressure(24 weeks)
- Reduction of hypercholesterolemia(24 weeks)
- Reduction of hyperglycemia(24 weeks)
研究者
Simon Barquera, MD, MS, PhD
Director of Research in Nutrition Policy and Programs.
Mexican National Institute of Public Health