Mil Familias-Santa Barbara's Operational Pilot to Understand Diabetes in the Latino Community



Status:Completed
Conditions:Peripheral Vascular Disease, Diabetes, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:August 24, 2017
End Date:December 31, 2018

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Mil Familias- Santa Barbara Operational Pilot

The Mil Familias Program is a 10-year initiative to reduce the burden of cardio-metabolic
disease among Latino families in the Central Coast of California. The Mil Familias Program
involves enrolling 1000 Latino families with at least one member in the family having type 2
diabetes, measuring the 5 determinants of human health: genetics, biology, behavior,
psychology and environment, training Latino community health workers ("Especialistas") ,
creating a Living Information (bio)Bank and planning culturally-relevant interventions.

The Mil Familias Pilot Study aims to develop, operationalize and refine methods to both
recruit and collect data from 100 adult participants pertaining to the 5 determinants of
human health: genetics, biology, behavior, psychology and environment. Specially-trained
Latino and bilingual community health workers known as "Especialistas" will be used to help
gather data and to serve as the participants trustworthy health companion. Over 100 variables
of information pertaining to the 5 determinants of human health (as listed above) will be
gathered and stored to create a Living Information (bio)Bank particular to Latinos. The
ultimate goal of this research is to provide the target population with effective,
culturally-relevant interventions that are geared toward population specific needs.

Inclusion criteria:

1. Males or females ≥ 18 years of age at Visit 1 (screening and enrollment).

2. Self-reported Hispanic and/or Latino heritage.

3. Currently residing in Santa Barbara County, California.

4. Established diagnosis of Type 2 diabetes for at least one year prior to enrollment
date.

5. Signed and dated written informed consent by the date of Visit 1.

6. Based on the research staff's judgment, subject must have a good understanding,
ability, and willingness to adhere to the protocol, including performance of
self-monitored data collection during the wearable device portion.

Exclusion Criteria:

1. Diagnosed severe cardiovascular disease, within the 6 months prior to enrollment Visit
1, defined as: previous stroke; decompensated heart failure New York Heart Association
class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial
bypass graft or angioplasty.

2. Life expectancy < 2 years.

3. Any active clinically significant disease or disorder, which in the investigator's
opinion could interfere with the participation of the trial.

4. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding
comprehension of study activities and informed consent.

5. Participation in other trials involving medication or device within 1 month prior to
Visit 1.

6. Known or suspected abuse of alcohol, narcotics, or illicit drugs.
We found this trial at
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Santa Barbara, California 93105
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Santa Barbara, CA
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