ObesityMPATPCDNCNCT02247635
Effect of a Treatment of Lifestyle Changes on the Prevalence of Metabolic Syndrome and Body Weight in Mexican Women
A study testing Healthy lifestyle and adherence in people with Obesity and Diabetes, run by Mexican National Institute of Public Health at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Obesity, Diabetes, High Blood Pressure
- What is being tested?
- Healthy lifestyle and adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- Kidney failure
- Hypothyroidism,
- Cancer,
- Anxiety or depression
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Mexican National Institute of Public Health
Cuernavaca, Morelos, 62100
About this study
Official 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.
Read more
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.
Read the detailed description
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.
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 Metabolic diseases and achieve a better control.
The changes in lifestyle are the foundation of any strategy for the treatment of chronical diseases . The patients require counseling to effect change in their behavior and improve their risk of mortality and morbidities. So far, interventions to improve treatment of patients with chronic diseases, not including diet and exercise recommendations, has not reported any significant positive change. Moreover, in Mexico there is still no method or reference tool to assess adherence. It has been reported that healthy lifestyles achieve positive changes on cardiovascular risk factors, however, no known methodology to help patients overcome the barriers that prevent them from adopting and adhering to the recommendations that are prescribed providers of health services. Therefore, the objective of this study is to assess if a multidisciplinary treatment that stimulates the constant practice of physical activity and intake of a hypocaloric diet, reduces the prevalence of metabolic chronic diseases such as obesity, diabetes, hypertension and dyslipidemia, and improves the control, in comparison with a traditional medical treatment in Mexican women. Also, to develop a methodology validated in Mexican population to identify barriers that affect adherence to treatment assessing their impact through a variety of quantitative indicators of health.
This project was conducted in 2 phases.
PHASE 1 Development of the tool for identifying barriers. In a private hospital care to chronic noncommunicable diseases, were called patients with co-morbidities associated with overweight and obesity (diabetes mellitus, dyslipidemia, hypertension) to identify common barriers they face to adequately follow through treatment the application of a validated questionnaire. The results will be used as reference for the discussion of traditional treatment algorithms based on the Mexican standards for the management of obesity, hypertension, diabetes and dyslipidemia.
PHASE 2. Design and implementation of the intervention
Phase 2 began with the recruitment of study subjects. The recruitment was done by a local advertising campaign that included posters and leaflets in the city the Cuernavaca, Morelos. México.
Were recruited a group of 180 patients with overweight and two of the following co-morbidities: diabetes mellitus, dyslipidemia or hypertension. All study subjects will be randomized to a control group and intervention. The intervention will last 24 weeks. The control group will receive traditional clinical care and the intervention group will receive a behavioral intervention to improve adherence.
The design of the intervention is based in the the stages-of-change model (also referred to as the transtheoretical model) identifies five stages through which individuals progress as they change behaviours, and stage-matched strategies that predict progress to each subsequent stage of change.
The stages of change are:
Precontemplation at this stage the subject does not plan to make an effort to adhere to treatment or to change your behavior. (Not considering changing behavior in the next 6 months),
The second is called "contemplation", the person admits that there is a risk behavior or beneficial and begin thinking about trying to change or adopt. (Considering changing behavior in the next 6 months),
The third is "preparation" in this stage the person intends to initiate behavior change, strategies and plans to acquire solutions. (Planning to change behavior during the next 30 days),
The fourth is "action" has become the person intended in the expected action (in this study the action is to improve adherence to treatment). (Currently changing behavior)
The fifth is "maintenance", here the change has been established as usual. (Successful behavior change for at least 6 months).
There is a sixth stage called "relapse", where the person returns to the behaviors that had been changed, abandoned the effort and go to the pre-action stages.
Stages of change describe an individual's motivational readiness to change.
The specific tools that contain the intervention program are:
Preparation
At this stage various strategies will be developed:
- Educational texts
- Individual medical advice
- Written contract of engagement The objective of this stage is to make the individual reflect on his health.
Action At this stage the individual begins proper actions to get a better adherence It will provide enough printed material that allows it to achieve its goals in diet, physical activity and taking medications.
There will be a computerized database (software) with which you can update the progress and barriers presented by the individual and be able to access either the nutritionist doctor or psychologist
Description of the tools:
- Educational texts. Based on feedback from patients and doctors, nutritionists and psychologists experts, will be designed brochures and educational leaflets with practical advice to achieve intermediate goals and the end of each treatment.
- Consultation and personalized feedback Develop a scheme for service providers (doctors, nutritionists and psychologists) to provide attention individual, the query will be adjusted to the level of adherence achieved.
In the query are used as reference treatment guidelines of the ADA and the Third Adult Treatment Panel (ATP III).
- Nutrition. The consultation will be given by a nutritionist trained to give dietary treatment based on available activities and times of the patient.
- Physical activity. The type of activity will be designed by an expert in the field and will be prescribed by nutritionist taking into account the patient's age and abilities.
Data collection will be done with different tools according to the phase of the project
Phase 1:
- Identification of barriers to treatment through the application of validated questionnaires.
Phase 2:
- Identification and socioeconomic data through the application of two questionnaires.
- Anthropometry: weight with scale Tanita model BC-418. Height with stadiometer SECA, model 220. Waist with a ribbon of flexible glass fiber of 0.5 cm in width and a precision of 1 mm.
- The measurement of intima-media thickness of carotid is made with Ultrasound SONOSITE PLUS model 180.
- Collection of biological samples for determination of biochemical parameters like glucose, glycosylated hemoglobin, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides.
Variables
Dependent. The dependent variable or outcome will be reduction in the prevalence of obesity and comorbidities (such as hypertension, diabetes, dyslipidemia), and control measured through weight loss, and decrease in blood pressure, fasting glucose, and cholesterol.
Independent. The independent variable is the lifestyle and behavioral program.
Data Analysis. Will present descriptive statistics for the dependent variables weight, fasting glucose, HbA1c, triglycerides, HDL-C, LDL-C, blood pressure and intima-media thickness.
Each group will analyze the mean difference in measurement time (initial, intermediate and final) for mean difference test
The differences between the control and intervention group were analyzed using three strategies: 1) by intention to treat (including patients who dropped out), 2) full support to the intervention (patients who completed the program), and 3) for proper administration of the intervention, ie an analysis will be specific to those subjects who received the intervention effectively by the physician and nutritionist (patients intervened correctly).
- Conditions
- Obesity, Diabetes, High Blood Pressure, Dyslipidemia
- Being tested
- Healthy lifestyle and adherence
- Keywords
- Treatment adherence, Behavioral model of health care, Healthy lifestyle, Chronic metabolic diseases, Metabolic syndrome, Obesity
- Medical subject headings
- Obesity, Diabetes Mellitus, Hypertension, Dyslipidemias, Treatment Adherence and Compliance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle and adherenceBehavioural
Behavioral intervention to improve adherence to treatment and 1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake <30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle.
The model consists of monthly visits to the doctor, nutritionist and psychologist, for screening cardiometabolic risk factors, to know limitations on treatment adherence, to start intervention to evaluate reasons for success or failure, to evaluate and maintain motivation to adherence to diet, physical activity and medication and long-term care
| Study group | Role | What they receive |
|---|---|---|
| Conventional medical treatment | No intervention | Based on the clinical guidelines of the Ministry of Health, medical treatment was provided and consisted in counseling for chronic diseases such as obesity, hyperglycemia, hypertension, dyslipidemia |
| Healthy lifestyle and adherence | Active comparator | 1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake <30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle. Receives: Behavioral: Healthy lifestyle and adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks
Secondary outcomes (4)
Reduction of hyperglycemia
To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
Measured: 24 weeks
Weight loss
To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
Measured: 24 weeks
Reduction of high blood pressure
To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
Measured: 24 weeks
Reduction of hypercholesterolemia
To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mexican National Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Simon Barquera, MD, MS, PhD, Mexican National Institute of Public Health
- Investigators
- Simón Barquera, PhD, Principal investigator, Mexican National Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247635
- Sponsor's protocol ID
- CINYS 410
- Other IDs
- 000000000044415
- Acronym
- MPATPCDNC
- Status last verified
- Oct 2014
- First submitted
- 17 Sep 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02247635
- Acronym / sponsor ID
- MPATPCDNC / CINYS 410
- Conditions
- Obesity, Diabetes, High Blood Pressure, Dyslipidemia
- Keywords
- Treatment adherence, Behavioral model of health care, Healthy lifestyle, Chronic metabolic diseases, Metabolic syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mexican National Institute of Public HealthOther government
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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 Metabolic diseases and achieve a better control.
The changes in lifestyle are the foundation of any strategy for the treatment of chronical diseases . The patients require counseling to effect change in their behavior and improve their risk of mortality and morbidities. So far, interventions to improve treatment of patients with chronic diseases, not including diet and exercise recommendations, has not reported any significant positive change. Moreover, in Mexico there is still no method or reference tool to assess adherence. It has been reported that healthy lifestyles achieve positive changes on cardiovascular risk factors, however, no known methodology to help patients overcome the barriers that prevent them from adopting and adhering to the recommendations that are prescribed providers of health services. Therefore, the objective of this study is to assess if a multidisciplinary treatment that stimulates the constant practice of physical activity and intake of a hypocaloric diet, reduces the prevalence of metabolic chronic diseases such as obesity, diabetes, hypertension and dyslipidemia, and improves the control, in comparison with a traditional medical treatment in Mexican women. Also, to develop a methodology validated in Mexican population to identify barriers that affect adherence to treatment assessing their impact through a variety of quantitative indicators of health.
This project was conducted in 2 phases.
PHASE 1 Development of the tool for identifying barriers. In a private hospital care to chronic noncommunicable diseases, were called patients with co-morbidities associated with overweight and obesity (diabetes mellitus, dyslipidemia, hypertension) to identify common barriers they face to adequately follow through treatment the application of a validated questionnaire. The results will be used as reference for the discussion of traditional treatment algorithms based on the Mexican standards for the management of obesity, hypertension, diabetes and dyslipidemia.
PHASE 2. Design and implementation of the intervention
Phase 2 began with the recruitment of study subjects. The recruitment was done by a local advertising campaign that included posters and leaflets in the city the Cuernavaca, Morelos. México.
Were recruited a group of 180 patients with overweight and two of the following co-morbidities: diabetes mellitus, dyslipidemia or hypertension. All study subjects will be randomized to a control group and intervention. The intervention will last 24 weeks. The control group will receive traditional clinical care and the intervention group will receive a behavioral intervention to improve adherence.
The design of the intervention is based in the the stages-of-change model (also referred to as the transtheoretical model) identifies five stages through which individuals progress as they change behaviours, and stage-matched strategies that predict progress to each subsequent stage of change.
The stages of change are:
Precontemplation at this stage the subject does not plan to make an effort to adhere to treatment or to change your behavior. (Not considering changing behavior in the next 6 months),
The second is called "contemplation", the person admits that there is a risk behavior or beneficial and begin thinking about trying to change or adopt. (Considering changing behavior in the next 6 months),
The third is "preparation" in this stage the person intends to initiate behavior change, strategies and plans to acquire solutions. (Planning to change behavior during the next 30 days),
The fourth is "action" has become the person intended in the expected action (in this study the action is to improve adherence to treatment). (Currently changing behavior)
The fifth is "maintenance", here the change has been established as usual. (Successful behavior change for at least 6 months).
There is a sixth stage called "relapse", where the person returns to the behaviors that had been changed, abandoned the effort and go to the pre-action stages.
Stages of change describe an individual's motivational readiness to change.
The specific tools that contain the intervention program are:
Preparation
At this stage various strategies will be developed:
- Educational texts
- Individual medical advice
- Written contract of engagement The objective of this stage is to make the individual reflect on his health.
Action At this stage the individual begins proper actions to get a better adherence It will provide enough printed material that allows it to achieve its goals in diet, physical activity and taking medications.
There will be a computerized database (software) with which you can update the progress and barriers presented by the individual and be able to access either the nutritionist doctor or psychologist
Description of the tools:
- Educational texts. Based on feedback from patients and doctors, nutritionists and psychologists experts, will be designed brochures and educational leaflets with practical advice to achieve intermediate goals and the end of each treatment.
- Consultation and personalized feedback Develop a scheme for service providers (doctors, nutritionists and psychologists) to provide attention individual, the query will be adjusted to the level of adherence achieved.
In the query are used as reference treatment guidelines of the ADA and the Third Adult Treatment Panel (ATP III).
- Nutrition. The consultation will be given by a nutritionist trained to give dietary treatment based on available activities and times of the patient.
- Physical activity. The type of activity will be designed by an expert in the field and will be prescribed by nutritionist taking into account the patient's age and abilities.
Data collection will be done with different tools according to the phase of the project
Phase 1:
- Identification of barriers to treatment through the application of validated questionnaires.
Phase 2:
- Identification and socioeconomic data through the application of two questionnaires.
- Anthropometry: weight with scale Tanita model BC-418. Height with stadiometer SECA, model 220. Waist with a ribbon of flexible glass fiber of 0.5 cm in width and a precision of 1 mm.
- The measurement of intima-media thickness of carotid is made with Ultrasound SONOSITE PLUS model 180.
- Collection of biological samples for determination of biochemical parameters like glucose, glycosylated hemoglobin, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides.
Variables
Dependent. The dependent variable or outcome will be reduction in the prevalence of obesity and comorbidities (such as hypertension, diabetes, dyslipidemia), and control measured through weight loss, and decrease in blood pressure, fasting glucose, and cholesterol.
Independent. The independent variable is the lifestyle and behavioral program.
Data Analysis. Will present descriptive statistics for the dependent variables weight, fasting glucose, HbA1c, triglycerides, HDL-C, LDL-C, blood pressure and intima-media thickness.
Each group will analyze the mean difference in measurement time (initial, intermediate and final) for mean difference test
The differences between the control and intervention group were analyzed using three strategies: 1) by intention to treat (including patients who dropped out), 2) full support to the intervention (patients who completed the program), and 3) for proper administration of the intervention, ie an analysis will be specific to those subjects who received the intervention effectively by the physician and nutritionist (patients intervened correctly).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional medical treatment | No intervention | –Based on the clinical guidelines of the Ministry of Health, medical treatment was provided and consisted in counseling for chronic diseases such as obesity, hyperglycemia, hypertension, dyslipidemia |
| Healthy lifestyle and adherence | Active comparator | Behavioral: Healthy lifestyle and adherence1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake <30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women from 19 to 65 years old
- Body mass index ≥ 25.0 - ≤39.9 or abdominal obesity
- With previous medical diagnosis:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy lifestyle and adherenceBehavioral intervention to improve adherence to treatment and 1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake <30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle. The model consists of monthly visits to the doctor, nutritionist and psychologist, for screening cardiometabolic risk factors, to know limitations on treatment adherence, to start intervention to evaluate reasons for success or failure, to evaluate and maintain motivation to adherence to diet, physical activity and medication and long-term care | Behavioural | Healthy lifestyle and adherence |
Primary outcome
Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia)
Time frame: 24 weeks
To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
4 secondary outcomes
Reduction of hyperglycemia
Time frame: 24 weeks
Weight loss
Time frame: 24 weeks
Reduction of high blood pressure
Time frame: 24 weeks
Reduction of hypercholesterolemia
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simón Barquera, PhD principal investigator
Mexican National Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy lifestyle and adherence in people with Obesity and Diabetes, run by Mexican National Institute of Public Health at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014.