Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes

NCT02899390 | Completed

• 1 other identifier: CentroIAD
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

Diabetes is a major non communicable chronic diseases in the world. It occupies the fourth or fifth leading cause of death in most high-income countries and there is strong evidence that has epidemic proportions in many developing countries, including Mexico. Like diabetes, prediabetes is associated with obesity and insulin resistance, thus promoting a lifestyle with healthy eating and physical activity can reduce weight and in turn the risk of diabetes. Several studies have shown that it is possible to prevent or delay the development of type 2 diabetes through a lifestyle intervention based on diet and physical activity. The National Diabetes Prevention Program is a study based on the Diabetes Prevention Program conducted in real-world conditions. It is known that the acculturation of some ethnic groups has led to the increase in certain chronic degenerative diseases due to increased associated risk factors. The rural Yaqui tribe has a high prevalence of overweight, obesity, high triglycerides and type 2 diabetes. In addition to the rural Yaqui tribe there is another settlement of this tribe in the city of Hermosillo Sonora. Information on the health of this ethnic group is limited, however, it is known that being seated in an urban setting with an obesogenic lifestyle, which has been shown to have serious health effects in other populations, suggesting a high prevalence chronic non-communicable diseases such as obesity, type 2 diabetes and hypertension at this ethnic group. The present study is a translational research clinical trial to evaluate the effectiveness of the National Diabetes Prevention Program to improve obesity parameters (weight, BMI, waist circumference) and increase physical activity in adults who are at risk of diabetes in the Yaqui tribe established in Hermosillo, Sonora.

Conditions

Prediabetes; Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Body weight change

  After 16 weekly sessions

Secondary Outcomes (12)

• Change in Body Mass Index

  After 16 weekly sessions

• Change in waist circumference

  After 16 weekly sessions

• Change in body fat percentage

  After 16 weekly sessions

• Change in systolic and diastolic blood pressure

  After 16 weekly sessions

• Change in fasting glucose

  After 16 weekly sessions

Study Arms (1)

Lifestyle Intervention

EXPERIMENTAL

All the participants will be offered group and individual sessions to help them accomplish weight loss and also increase physical activity.

Behavioral: Lifestyle Intervention

Interventions

Lifestyle Intervention BEHAVIORAL

Before implementation of the National Diabetes Prevention Program, adaptations will be made in order to be culturally acceptable in the community taking in consideration the type of food they eat and their activities in the population. The lifestyle intervention will be implemented by group and individual sessions and is aimed at achieving a 7% loss weight from baseline and 150 minutes per week of physical activity. Sessions will be held weekly in a period of 6 months. Individual sessions consist in nutritional counseling according to energy needs and food preferences of each participant.

Lifestyle Intervention

Eligibility Criteria

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

You may qualify if:

• Being part of the Yaqui tribe established in Hermosillo, Sonora.
• Age 20 years and less than 65
• FINDRISC score of 12 or higher
• Desire of participate
• Sign up the consent form

You may not qualify if:

• Diabetes diagnosis or another chronic disease
• Have been suffered a myocardial infarction in the last 6 months
• Cardiovascular disease
• Be seriously ill
• Use of medication that alter glucose tolerance
• Use of medicaments to lost weight
• Present conditions that affect their participation in the study (use of drugs or inability to exercise

Sponsors & Collaborators

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

Study Sites (3)

Centro de Investigación en Alimentación y Desarrollo

Hermosillo, Sonora, 83304, Mexico

Location

Centro de Salud Urbano Los Naranjos

Hermosillo, Sonora, Mexico

Location

Elementary School Lázaro Mercado

Hermosillo, Sonora, Mexico

Location

MeSH Terms

Conditions

Prediabetic State; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; 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: September 9, 2016
• First Posted: September 14, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

ME (3)