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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02899390
Date of registration:	09/09/2016
Prospective Registration:	No
Primary sponsor:	Centro de Investigación en Alimentación y Desarrollo A.C.
Public title:	Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
Scientific 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
Date of first enrolment:	September 2016
Target sample size:	14
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02899390
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Mexico

Contacts

Name:	Julián Esparza-Romero, Ph.D.
Address:
Telephone:
Email:
Affiliation:	Centro de Investigación en Alimentación y Desarrollo

Key inclusion & exclusion 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

Age minimum: 20 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Overweight

Prediabetes

Intervention(s)

Behavioral: Lifestyle Intervention

Primary Outcome(s)

Body weight change [Time Frame: After 16 weekly sessions]

Secondary Outcome(s)

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]

Change in fasting insulin [Time Frame: After 16 weekly sessions]

Change in triglycerides [Time Frame: After 16 weekly sessions]

Change in systolic and diastolic blood pressure [Time Frame: After 16 weekly sessions]

Change in LDL-cholesterol [Time Frame: After 16 weekly sessions]

Change in total cholesterol [Time Frame: After 16 weekly sessions]

Change in Body Mass Index [Time Frame: After 16 weekly sessions]

Change in the Beck Depression Inventory score [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 fasting glucose [Time Frame: After 16 weekly sessions]

Secondary ID(s)

CentroIAD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universidad de Sonora

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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