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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02899390
Enrollment
14
Registered
2016-09-14
Start date
2016-09-30
Completion date
2017-06-30
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight, Prediabetes

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.

Interventions

BEHAVIORALLifestyle 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.

Sponsors

Universidad de Sonora
CollaboratorOTHER
Centro de Investigación en Alimentación y Desarrollo A.C.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Body weight changeAfter 16 weekly sessions

Secondary

MeasureTime frame
Change in waist circumferenceAfter 16 weekly sessions
Change in body fat percentageAfter 16 weekly sessions
Change in systolic and diastolic blood pressureAfter 16 weekly sessions
Change in fasting glucoseAfter 16 weekly sessions
Change in total cholesterolAfter 16 weekly sessions
Change in Body Mass IndexAfter 16 weekly sessions
Change in triglyceridesAfter 16 weekly sessions
Change in fasting insulinAfter 16 weekly sessions
Change in the Beck Depression Inventory scoreAfter 16 weekly sessions
Change in the Short Form-36 Health Survey scoreAfter 16 weekly sessions
Change in the Perceived Stress Scale (PSS) -14 scoreAfter 16 weekly sessions
Change in LDL-cholesterolAfter 16 weekly sessions

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026