Program of Healthy Lifestyle Promotion in Yaqui Indigenous in Sonora

NCT ID: NCT03599817

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2021-03-31

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 overweight/obese. While in 2014 it was reported that 8.5% 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 72.5% of the Mexican population suffers from overweight/obesity. In addition, in 2006, 14.4% 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 18.3% 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.

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Conditions

Overweight; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy lifestyle promotion program

All the participants of the intervention program will be offered group sessions focused on healthy eating, promotion of physical activity and behavioral changes. In this way, the loss of body weight and the increase of physical activity will be promoted. Translating into an improvement in obesity parameters and cardiovascular and metabolic risk factors, to reduce the risk of developing type 2 diabetes.

Group Type: EXPERIMENTAL

Healthy lifestyle promotion program

Intervention Type: BEHAVIORAL

Before implementing the healthy lifestyle program, it will be adapted according to the characteristics of the Yaqui community, their type of food and the activities they carry out, so that the intervention program is culturally accepted by the community. The intervention will consist of two stages, an intensive phase and a maintenance phase. In the intensive phase, 16 weekly group sessions will be given with the aim of achieving a 5% body weight loss and ensuring that the participants do at least 150 minutes of physical activity per week. In the maintenance phase, 6 monthly group sessions will be given in order to maintain the results achieved in the first stage. In the same maintenance phase, but from 12 to 18 months, the lifestyle trainers will make home visits to the participants. Lifestile trainers will record body weight, physical activity and food consumption. In this period there will be no sessions, only monthly visits.

Interventions

Healthy lifestyle promotion program

Before implementing the healthy lifestyle program, it will be adapted according to the characteristics of the Yaqui community, their type of food and the activities they carry out, so that the intervention program is culturally accepted by the community. The intervention will consist of two stages, an intensive phase and a maintenance phase. In the intensive phase, 16 weekly group sessions will be given with the aim of achieving a 5% body weight loss and ensuring that the participants do at least 150 minutes of physical activity per week. In the maintenance phase, 6 monthly group sessions will be given in order to maintain the results achieved in the first stage. In the same maintenance phase, but from 12 to 18 months, the lifestyle trainers will make home visits to the participants. Lifestile trainers will record body weight, physical activity and food consumption. In this period there will be no sessions, only monthly visits.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and women being of the Yaqui tribe
• Age 20 years and less than 65
• Overweight or obese (BMI ≥25 kg/m2)
• FINDRISC score of 12 or higher
• Sign up the consent form and wish to participate

Exclusion Criteria

• Subjects with diagnosis previous of diabetes
• Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg)
• Renal insufficiency
• Hepatopathies
• Neoplasms
• Inflammatory and traumatic rheumatoid arthritis
• Cardiovascular disease
• Chronic obstructive pulmonary disease
• Thyroid disease
• Systemic lupus erythematosus
• Inflammatory bowel disease
• HIV
• Psoriasis
• Mesangial proliferative glomerulonephritis
• Seriously ill
• Bacterial and viral infections at the time of taking the blood sample
• Pregnant women and/or stage of lactation
• Subjects with limitations to carry out physical exercise
• Subjects that have participated in another similar program
• Subjects in pharmacological treatment for obesity
• People under pharmacological treatment that alter glucose tolerance and lipid levels

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Investigación en Alimentación y Desarrollo A.C.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julián Esparza-Romero, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Centro de Investigación en Alimentación y Desarrollo

Locations

Dispensario médico

Ciudad Obregón, Loma de Guamúchil, Mexico

Dispensario médico

Guaymas, Pótam, Mexico

Dispensario médico

Guaymas, Tórim, Mexico

Dispensario médico

Guaymas, Vícam, Mexico

Countries

Mexico

Other Identifiers

JER002

Identifier Type: -

Identifier Source: org_study_id