PrediabetesNCT02899390
Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
A study testing Lifestyle Intervention in people with Prediabetes and Obesity, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 3 sites in Mexico.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Obesity, Overweight
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesMexico
- Study dates
- Sep 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Centro de Investigación en Alimentación y Desarrollo
Hermosillo, Sonora, 83304
Centro de Salud Urbano Los Naranjos
Hermosillo, Sonora
Elementary School Lázaro Mercado
Hermosillo, Sonora
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Prediabetes, Obesity, Overweight
- Being tested
- Lifestyle Intervention
- Medical subject headings
- Prediabetic State, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | All the participants will be offered group and individual sessions to help them accomplish weight loss and also increase physical activity. Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Measured: After 16 weekly sessions
Secondary outcomes (12)
Change in Body Mass Index
Measured: After 16 weekly sessions
Change in waist circumference
Measured: After 16 weekly sessions
Change in body fat percentage
Measured: After 16 weekly sessions
Change in systolic and diastolic blood pressure
Measured: After 16 weekly sessions
Change in fasting glucose
Measured: After 16 weekly sessions
Change in total cholesterol
Measured: After 16 weekly sessions
Change in LDL-cholesterol
Measured: After 16 weekly sessions
Change in triglycerides
Measured: After 16 weekly sessions
Change in fasting insulin
Measured: After 16 weekly sessions
Change in the Beck Depression Inventory score
Measured: After 16 weekly sessions
Change in the Short Form-36 Health Survey score
Measured: After 16 weekly sessions
Change in the Perceived Stress Scale (PSS) -14 score
Measured: After 16 weekly sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Sonora
- Responsible party
- Sponsor
- Investigators
- Julián Esparza-Romero, Ph.D., Principal investigator, Centro de Investigación en Alimentación y Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899390
- Sponsor's protocol ID
- CentroIAD
- Status last verified
- Jul 2017
- First submitted
- 9 Sep 2016
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02899390
- Acronym / sponsor ID
- CentroIAD
- Conditions
- Prediabetes, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.University, hospital or other
- Collaborators
- Universidad de Sonora
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionAll the participants will be offered group and individual sessions to help them accomplish weight loss and also increase physical activity. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionBefore 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. | Behavioural | Lifestyle Intervention |
Primary outcome
Body weight change
Time frame: After 16 weekly sessions
12 secondary outcomes
Change in Body Mass Index
Time frame: After 16 weekly sessions
Change in waist circumference
Time frame: After 16 weekly sessions
Change in body fat percentage
Time frame: After 16 weekly sessions
Change in systolic and diastolic blood pressure
Time frame: After 16 weekly sessions
Change in fasting glucose
Time frame: After 16 weekly sessions
Change in total cholesterol
Time frame: After 16 weekly sessions
Change in LDL-cholesterol
Time frame: After 16 weekly sessions
Change in triglycerides
Time frame: After 16 weekly sessions
Change in fasting insulin
Time frame: After 16 weekly sessions
Change in the Beck Depression Inventory score
Time frame: After 16 weekly sessions
Change in the Short Form-36 Health Survey score
Time frame: After 16 weekly sessions
Change in the Perceived Stress Scale (PSS) -14 score
Time frame: After 16 weekly sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julián Esparza-Romero, Ph.D. principal investigator
Centro de Investigación en Alimentación y Desarrollo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Prediabetes and Obesity, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 3 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight change (time frame: After 16 weekly sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.