Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
Primary Purpose
Prediabetes, Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by

About this trial
This is an interventional prevention trial for Prediabetes
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
Sites / Locations
- Centro de Investigación en Alimentación y Desarrollo
- Centro de Salud Urbano Los Naranjos
- Elementary School Lázaro Mercado
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle Intervention
Arm Description
All the participants will be offered group and individual sessions to help them accomplish weight loss and also increase physical activity.
Outcomes
Primary Outcome Measures
Body weight change
Secondary Outcome Measures
Change in Body Mass Index
Change in waist circumference
Change in body fat percentage
Change in systolic and diastolic blood pressure
Change in fasting glucose
Change in total cholesterol
Change in LDL-cholesterol
Change in triglycerides
Change in fasting insulin
Change in the Beck Depression Inventory score
Change in the Short Form-36 Health Survey score
Change in the Perceived Stress Scale (PSS) -14 score
Full Information
NCT ID
NCT02899390
First Posted
September 9, 2016
Last Updated
July 20, 2017
Sponsor
Centro de Investigación en Alimentación y Desarrollo A.C.
Collaborators
Universidad de Sonora
1. Study Identification
Unique Protocol Identification Number
NCT02899390
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Investigación en Alimentación y Desarrollo A.C.
Collaborators
Universidad de Sonora
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Obesity, Overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
All the participants will be offered group and individual sessions to help them accomplish weight loss and also increase physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
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 Measure Information:
Title
Body weight change
Time Frame
After 16 weekly sessions
Secondary Outcome Measure Information:
Title
Change in Body Mass Index
Time Frame
After 16 weekly sessions
Title
Change in waist circumference
Time Frame
After 16 weekly sessions
Title
Change in body fat percentage
Time Frame
After 16 weekly sessions
Title
Change in systolic and diastolic blood pressure
Time Frame
After 16 weekly sessions
Title
Change in fasting glucose
Time Frame
After 16 weekly sessions
Title
Change in total cholesterol
Time Frame
After 16 weekly sessions
Title
Change in LDL-cholesterol
Time Frame
After 16 weekly sessions
Title
Change in triglycerides
Time Frame
After 16 weekly sessions
Title
Change in fasting insulin
Time Frame
After 16 weekly sessions
Title
Change in the Beck Depression Inventory score
Time Frame
After 16 weekly sessions
Title
Change in the Short Form-36 Health Survey score
Time Frame
After 16 weekly sessions
Title
Change in the Perceived Stress Scale (PSS) -14 score
Time Frame
After 16 weekly sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julián Esparza-Romero, Ph.D.
Organizational Affiliation
Centro de Investigación en Alimentación y Desarrollo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigación en Alimentación y Desarrollo
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83304
Country
Mexico
Facility Name
Centro de Salud Urbano Los Naranjos
City
Hermosillo
State/Province
Sonora
Country
Mexico
Facility Name
Elementary School Lázaro Mercado
City
Hermosillo
State/Province
Sonora
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
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