Clinical trial NCT03599817: Program of Healthy Lifestyle Promotion in Yaqui Indigenous in Sonora
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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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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

Primary outcomes:
measure: Body weight (kg)
timeFrame: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
measure: Triglycerides (mg/dL)
timeFrame: Change in triglycerides from baseline to 6 months and change in triglycerides baseline to 12 months
measure: Fasting glucose (mg/dL)
timeFrame: Change in fasting glucose from baseline to 6 months and change in fasting glucose from baseline to 12 months
measure: IL-6 (pg/ml)
timeFrame: Change in IL-6 from baseline to 12 months
Secondary outcomes:
measure: Body Mass Index (kg/m2)
timeFrame: Change in Body Mass Index from baseline to 6 months and change in Body Mass Index from baseline to 12 months
measure: Waist circumference (cm)
timeFrame: Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
measure: Body fat percentage (%)
timeFrame: Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
measure: Fasting insulin (mg/dL)
timeFrame: Change in fasting insulin from baseline to 6 months and change in fasting insulin from baseline to 12 months
measure: Total cholesterol (mg/dL)
timeFrame: Change in total cholesterol from baseline to 6 months and change in total cholesterol from baseline to 12 months
measure: LDL-cholesterol (mg/dL)
timeFrame: Change in LDL-cholesterol from baseline to 6 months and change in LDL-cholesterol from baseline to 12 months
measure: HDL-cholesterol (mg/dL)
timeFrame: Change in HDL-cholesterol from baseline to 6 months and change in HDL-cholesterol from baseline to 12 months
measure: Systolic and diastolic blood pressure (mmHg)
timeFrame: Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
measure: Physical activity (minutes/week)
timeFrame: Change in physical activity from baseline to 6 months and change in physical activity from baseline to 12 months
measure: Tumor Necrosis Factor-α (TNF-α) (pg/ml)
timeFrame: Change in TNF-α from baseline to 12 months
measure: Adiponectin (µg/ml)
timeFrame: Change in adiponectin from baseline to 12 months
measure: Body weight (kg)
timeFrame: Change in body weight from 6 months to 12 and 18 months
measure: Body Mass Index (kg/m2)
timeFrame: Change in body mass index from 6 months to 12 and 18 months
measure: Waist circumference (cm)
timeFrame: Change in waist circumference from 6 months to 12 and 18 months
measure: Body fat percentage (%)
timeFrame: Change in waist circumference from 6 months to 12 and 18 months
measure: Fasting glucose (mg/dL)
timeFrame: Change in fasting glucose from 6 months to 12 and 18 months
measure: Total cholesterol (mg/dL)
timeFrame: Change in total cholesterol from 6 months to 12 and 18 months
measure: LDL-cholesterol (mg/dL)
timeFrame: Change in LDL-cholesterol from 6 months to 12 and 18 months
measure: HDL-cholesterol (mg/dL)
timeFrame: Change in HDL-cholesterol from 6 months to 12 and 18 months
measure: Systolic and diastolic blood pressure (mmHg)
timeFrame: Change in systolic and diastolic blood pressure from 6 months to 12 and 18 months
measure: Physical activity (minutes/week)
timeFrame: Change in physical activity from 6 months to 12 and 18 months
Other outcomes:
Locations:
city: Cd. Obregon
country: Mexico
facility: Dispensario médico
state: Loma De Guamúchil
city: Guaymas
country: Mexico
facility: Dispensario médico
state: Pótam
city: Guaymas
country: Mexico
facility: Dispensario médico
state: Tórim
city: Guaymas
country: Mexico
facility: Dispensario médico
state: Vícam
Study officials:
affiliation: Centro de Investigación en Alimentación y Desarrollo
name: Julián Esparza-Romero, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: