Program of Healthy Lifestyle Promotion in Yaqui Indigenous in Sonora

NCT03599817 | Unknown

• 1 other identifier: JER002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (4)

• Body weight (kg)

  Change in body weight

  Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months

• Triglycerides (mg/dL)

  Change in triglycerides

  Change in triglycerides from baseline to 6 months and change in triglycerides baseline to 12 months

• Fasting glucose (mg/dL)

  Change in fasting glucose

  Change in fasting glucose from baseline to 6 months and change in fasting glucose from baseline to 12 months

• IL-6 (pg/ml)

  Change in IL-6

  Change in IL-6 from baseline to 12 months

Secondary Outcomes (21)

• Body Mass Index (kg/m2)

  Change in Body Mass Index from baseline to 6 months and change in Body Mass Index from baseline to 12 months

• Waist circumference (cm)

  Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months

• Body fat percentage (%)

  Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months

• Fasting insulin (mg/dL)

  Change in fasting insulin from baseline to 6 months and change in fasting insulin from baseline to 12 months

• Total cholesterol (mg/dL)

  Change in total cholesterol from baseline to 6 months and change in total cholesterol from baseline to 12 months

Study Arms (1)

Healthy lifestyle promotion program

EXPERIMENTAL

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.

Behavioral: Healthy lifestyle promotion program

Interventions

Healthy lifestyle promotion program 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.

Healthy lifestyle promotion program

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Investigación en Alimentación y Desarrollo A.C.: lead

Study Sites (4)

Dispensario médico

Ciudad Obregón, Loma de Guamúchil, Mexico

Location

Dispensario médico

Guaymas, Pótam, Mexico

Location

Dispensario médico

Guaymas, Tórim, Mexico

Location

Dispensario médico

Guaymas, Vícam, Mexico

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julián Esparza-Romero, Ph.D

  Centro de Investigación en Alimentación y Desarrollo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: July 24, 2018
• Primary Completion: February 20, 2020
• Study Completion: March 1, 2021
• Last Updated: January 26, 2021

Record last verified: 2020-01

Locations

ME (4)