Obesity Clinical Trial
— MPATPCDNCOfficial title:
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
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:
1. 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.
2. 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.
Status | Completed |
Enrollment | 180 |
Est. completion date | August 2010 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Women from 19 to 65 years old - Body mass index = 25.0 - =39.9 or abdominal obesity - With previous medical diagnosis: 1. high fasting glucose 2. high blood pressure 3. dyslipidemia. Exclusion Criteria: - 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, - Cancer, - Anxiety or depression |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Mexican National Institute of Public Health | Cuernavaca, | Morelos |
Lead Sponsor | Collaborator |
---|---|
Mexican National Institute of Public Health |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia) | To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation) | 24 weeks | Yes |
Secondary | Reduction of hyperglycemia | To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation) | 24 weeks | No |
Secondary | Weight loss | To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation) | 24 weeks | Yes |
Secondary | Reduction of high blood pressure | To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation) | 24 weeks | No |
Secondary | Reduction of hypercholesterolemia | To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation) | 24 weeks | No |
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