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Clinical Trials/NCT02899390
NCT02899390
Completed
Not Applicable

Adaptation and Evaluation of a Diabetes Prevention Program About Parameters of Obesity, Physical Activity and Biochemical Parameters in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes

Centro de Investigación en Alimentación y Desarrollo A.C.3 sites in 1 country14 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prediabetes
Sponsor
Centro de Investigación en Alimentación y Desarrollo A.C.
Enrollment
14
Locations
3
Primary Endpoint
Body weight change
Status
Completed
Last Updated
8 years ago

Overview

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.

Detailed Description

The present project wants to know if a diabetes prevention program can reduce the risk of developing diabetes in adults at risk of the Yaqui tribe established in Hermosillo, through the loss of weight and physical activity, all these with an intensive lifestyle intervention program that provide them the benefits of a healthy nutrition and physical activity. The hypothesis is that a lifestyle intervention program addressed to adults in the Yaqui tribe, established in Hermosillo at risk of diabetes can significantly decrease the parameters of obesity in a period of 6 months and increase physical activity in the same time period.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
June 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Body weight change

Time Frame: After 16 weekly sessions

Secondary Outcomes

  • Change in triglycerides(After 16 weekly sessions)
  • Change in fasting insulin(After 16 weekly sessions)
  • Change in the Beck Depression Inventory score(After 16 weekly sessions)
  • Change in the Short Form-36 Health Survey score(After 16 weekly sessions)
  • Change in the Perceived Stress Scale (PSS) -14 score(After 16 weekly sessions)
  • 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)
  • Change in total cholesterol(After 16 weekly sessions)
  • Change in LDL-cholesterol(After 16 weekly sessions)

Study Sites (3)

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