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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02899390
Other study ID # CentroIAD
Secondary ID
Status Completed
Phase N/A
First received September 9, 2016
Last updated July 20, 2017
Start date September 2016
Est. completion date June 2017

Study information

Verified date July 2017
Source Centro de Investigación en Alimentación y Desarrollo A.C.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date June 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Mexico Centro de Investigación en Alimentación y Desarrollo Hermosillo Sonora
Mexico Centro de Salud Urbano Los Naranjos Hermosillo Sonora
Mexico Elementary School Lázaro Mercado Hermosillo Sonora

Sponsors (2)

Lead Sponsor Collaborator
Centro de Investigación en Alimentación y Desarrollo A.C. Universidad de Sonora

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight change After 16 weekly sessions
Secondary Change in Body Mass Index After 16 weekly sessions
Secondary Change in waist circumference After 16 weekly sessions
Secondary Change in body fat percentage After 16 weekly sessions
Secondary Change in systolic and diastolic blood pressure After 16 weekly sessions
Secondary Change in fasting glucose After 16 weekly sessions
Secondary Change in total cholesterol After 16 weekly sessions
Secondary Change in LDL-cholesterol After 16 weekly sessions
Secondary Change in triglycerides After 16 weekly sessions
Secondary Change in fasting insulin After 16 weekly sessions
Secondary Change in the Beck Depression Inventory score After 16 weekly sessions
Secondary Change in the Short Form-36 Health Survey score After 16 weekly sessions
Secondary Change in the Perceived Stress Scale (PSS) -14 score After 16 weekly sessions
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