Ignite Creation Date:
2024-05-06 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03599817
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2018-07-16
Brief Title:
Program of Healthy Lifestyle Promotion in Yaqui Indigenous in Sonora
Sponsor:
Centro de Investigación en Alimentación y Desarrollo AC
Organization:
Centro de Investigación en Alimentación y Desarrollo AC
Study Overview
Official Title:
Healthy Lifestyle Promotion Program as a Strategy to Improve Obesity Parameters Cardiovascular and Metabolic Risk Factors in Yaquis Indigenous in the State of Sonora
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obesity has become an epidemic worldwide and is considered one of the main causes related to type 2 diabetes The World Health Organization reported that in 2016 39 of adults were overweight while the percentage of obesity was 13 together 1900 million people were overweightobese While in 2014 it was reported that 85 of the population in the world suffered from type 2 diabetes On the other hand in the national context the last report of 2016 that 725 of the Mexican population suffers from overweightobesity In addition in 2006 144 of Mexicans suffered from type 2 diabetes
Obesity is a complex chronic state that is developed by an imbalance between the energy ingested and the energy expended In addition obesity is considered a chronic inflammatory state of low degree of cause of the immune response generated as a consequence of the increase of adipose tissue what explains the imbalance in the markers of inflammation This inflammation condition has been related to the generation of insulin resistance the increase in glucose levels and the appearance of various pathologies such as type 2 diabetes and other risk factors for cardiovascular diseases
The Yaqui ethnic group is located in the center-south zone of the state of Sonora distributed in 8 traditional villages A recent study conducted in the Yaqui community reported a prevalence of overweight and obesity of 25 and 43 respectively In 2008 a prevalence of type 2 diabetes of 183 was reported in its inhabitants
On the other hand there are successful programs in reducing body weight through interventions aimed at modifying lifestyles such as eating habits and physical function called Lifestyle Modification Programs These programs have been supported through controlled and randomized clinical trials Such is the case of the Diabetes Prevention Program Which has achieved weight reduction and increased physical activity in the subjects treated The Diabetes Prevention Program has been recognized and adapted for the Centers for Disease Control and Prevention and has been dubbed the National Diabetes Prevention Program
The present study is a translational research clinical trial to evaluate the effectiveness of a program to promote the parameters of obesity and diabetes in the cardiovascular communities in the Yaqui community of the state of Sonora
Obesity is a complex chronic state that is developed by an imbalance between the energy ingested and the energy expended In addition obesity is considered a chronic inflammatory state of low degree of cause of the immune response generated as a consequence of the increase of adipose tissue what explains the imbalance in the markers of inflammation This inflammation condition has been related to the generation of insulin resistance the increase in glucose levels and the appearance of various pathologies such as type 2 diabetes and other risk factors for cardiovascular diseases
The Yaqui ethnic group is located in the center-south zone of the state of Sonora distributed in 8 traditional villages A recent study conducted in the Yaqui community reported a prevalence of overweight and obesity of 25 and 43 respectively In 2008 a prevalence of type 2 diabetes of 183 was reported in its inhabitants
On the other hand there are successful programs in reducing body weight through interventions aimed at modifying lifestyles such as eating habits and physical function called Lifestyle Modification Programs These programs have been supported through controlled and randomized clinical trials Such is the case of the Diabetes Prevention Program Which has achieved weight reduction and increased physical activity in the subjects treated The Diabetes Prevention Program has been recognized and adapted for the Centers for Disease Control and Prevention and has been dubbed the National Diabetes Prevention Program
The present study is a translational research clinical trial to evaluate the effectiveness of a program to promote the parameters of obesity and diabetes in the cardiovascular communities in the Yaqui community of the state of Sonora
Detailed Description:
The study focuses on knowing if the program of promotion of healthy lifestyle can reduce the risk of developing type 2 diabetes in adults of the Yaqui ethnic group with overweight obesity and with risk of diabetes of the state of Sonora through the loss of body weight and the promotion of physical activity in this way to improve obesity parameters and cardiovascular and metabolic risk factors
The primary hypothesis is that the implementation of a program promoting the healthy lifestyle aimed at adults of the Yaqui ethnic group of Sonora with a diagnosis of overweight or obesity and a Finnish Diabetes Risk Score FINDRISC 12 will significantly improve in the medium term 12 months the body weight triglycerides fasting glucose and interleukin-6 IL-6
The secondary hypotheses will be as follows the implementation of a program to promote a healthy lifestyle aimed at adults of the Yaqui ethnic group of Sonora with a diagnosis of overweight or obesity and FINDRISC score 12 will improve significantly in the short term 6 months obesity parameters blood glucose levels insulin lipid profile blood pressure and physical activity
The implementation of a healthy lifestyle promotion program aimed at adults of the Sonoran Yaqui ethnic group with a diagnosis of overweight or obesity and a FINDRISC score 12 will significantly improve medium-term 12 months obesity parameters blood levels of insulin lipid profile inflammation markers blood pressure and physical activity
The implementation of a healthy lifestyle promotion program aimed at adults of the Sonoran Yaqui ethnic group with a diagnosis of overweight or obesity and a FINDRISC score 12 will significantly improve long-term 18 months obesity parameters blood levels lipid profile blood pressure and physical activity
The primary hypothesis is that the implementation of a program promoting the healthy lifestyle aimed at adults of the Yaqui ethnic group of Sonora with a diagnosis of overweight or obesity and a Finnish Diabetes Risk Score FINDRISC 12 will significantly improve in the medium term 12 months the body weight triglycerides fasting glucose and interleukin-6 IL-6
The secondary hypotheses will be as follows the implementation of a program to promote a healthy lifestyle aimed at adults of the Yaqui ethnic group of Sonora with a diagnosis of overweight or obesity and FINDRISC score 12 will improve significantly in the short term 6 months obesity parameters blood glucose levels insulin lipid profile blood pressure and physical activity
The implementation of a healthy lifestyle promotion program aimed at adults of the Sonoran Yaqui ethnic group with a diagnosis of overweight or obesity and a FINDRISC score 12 will significantly improve medium-term 12 months obesity parameters blood levels of insulin lipid profile inflammation markers blood pressure and physical activity
The implementation of a healthy lifestyle promotion program aimed at adults of the Sonoran Yaqui ethnic group with a diagnosis of overweight or obesity and a FINDRISC score 12 will significantly improve long-term 18 months obesity parameters blood levels lipid profile blood pressure and physical activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None