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Completed

NCT Number: NCT02899390

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigación en Alimentación y Desarrollo, Hermosillo, Sonora, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Body weight change

    Time frame: After 16 weekly sessions

Secondary outcomes

  1. Change in Body Mass Index

    Time frame: After 16 weekly sessions

  2. Change in waist circumference

    Time frame: After 16 weekly sessions

  3. Change in body fat percentage

    Time frame: After 16 weekly sessions

  4. Change in systolic and diastolic blood pressure

    Time frame: After 16 weekly sessions

  5. Change in fasting glucose

    Time frame: After 16 weekly sessions

  6. Change in total cholesterol

    Time frame: After 16 weekly sessions

  7. Change in LDL-cholesterol

    Time frame: After 16 weekly sessions

  8. Change in triglycerides

    Time frame: After 16 weekly sessions

  9. Change in fasting insulin

    Time frame: After 16 weekly sessions

  10. Change in the Beck Depression Inventory score

    Time frame: After 16 weekly sessions

  11. Change in the Short Form-36 Health Survey score

    Time frame: After 16 weekly sessions

  12. Change in the Perceived Stress Scale (PSS) -14 score

    Time frame: After 16 weekly sessions

Sponsors and collaborators

Lead sponsor

Centro de Investigación en Alimentación y Desarrollo A.C.

Other

Collaborators

  • Universidad de Sonora

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 14, 2016
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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