Clinical trial NCT02899390: Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Obesity
Overweight
Lead sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
Sponsor class: OTHER
Collaborators: name: Universidad de Sonora
First posted: 2016-09-14
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Body weight change
timeFrame: After 16 weekly sessions
Secondary outcomes:
measure: Change in Body Mass Index
timeFrame: After 16 weekly sessions
measure: Change in waist circumference
timeFrame: After 16 weekly sessions
measure: Change in body fat percentage
timeFrame: After 16 weekly sessions
measure: Change in systolic and diastolic blood pressure
timeFrame: After 16 weekly sessions
measure: Change in fasting glucose
timeFrame: After 16 weekly sessions
measure: Change in total cholesterol
timeFrame: After 16 weekly sessions
measure: Change in LDL-cholesterol
timeFrame: After 16 weekly sessions
measure: Change in triglycerides
timeFrame: After 16 weekly sessions
measure: Change in fasting insulin
timeFrame: After 16 weekly sessions
measure: Change in the Beck Depression Inventory score
timeFrame: After 16 weekly sessions
measure: Change in the Short Form-36 Health Survey score
timeFrame: After 16 weekly sessions
measure: Change in the Perceived Stress Scale (PSS) -14 score
timeFrame: After 16 weekly sessions
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Investigación en Alimentación y Desarrollo
state: Sonora
city: Hermosillo
country: Mexico
facility: Centro de Salud Urbano Los Naranjos
state: Sonora
city: Hermosillo
country: Mexico
facility: Elementary School Lázaro Mercado
state: Sonora
Study officials:
affiliation: Centro de Investigación en Alimentación y Desarrollo
name: Julián Esparza-Romero, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: