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

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ClinicalTrials.gov Identifier: NCT02899390
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
Universidad de Sonora
Information provided by (Responsible Party):
Centro de Investigación en Alimentación y Desarrollo A.C.

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.


Condition or disease Intervention/treatment Phase
Prediabetes Obesity Overweight Behavioral: Lifestyle Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : September 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Lifestyle Intervention
All the participants will be offered group and individual sessions to help them accomplish weight loss and also increase physical activity.
Behavioral: Lifestyle Intervention

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 Outcome Measures :
  1. Body weight change [ Time Frame: After 16 weekly sessions ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899390


Locations
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Mexico
Centro de Investigación en Alimentación y Desarrollo
Hermosillo, Sonora, Mexico, 83304
Centro de Salud Urbano Los Naranjos
Hermosillo, Sonora, Mexico
Elementary School Lázaro Mercado
Hermosillo, Sonora, Mexico
Sponsors and Collaborators
Centro de Investigación en Alimentación y Desarrollo A.C.
Universidad de Sonora
Investigators
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Principal Investigator: Julián Esparza-Romero, Ph.D. Centro de Investigación en Alimentación y Desarrollo

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Responsible Party: Centro de Investigación en Alimentación y Desarrollo A.C.
ClinicalTrials.gov Identifier: NCT02899390     History of Changes
Other Study ID Numbers: CentroIAD
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Overweight
Prediabetic State
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases