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

Completed

Conditions studied: Type2 Diabetes Mellitus, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT03736486

Run by

Sansum Diabetes Research Institute

People needed

100

Starts

2017-08-24

Expected to finish

2018-12-31

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females ≥ 18 years of age at Visit 1 (screening and enrollment).
• Self-reported Hispanic and/or Latino heritage.
• Currently residing in Santa Barbara County, California.
• Established diagnosis of Type 2 diabetes for at least one year prior to enrollment date.
• Signed and dated written informed consent by the date of Visit 1.
• 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.

You may not qualify if…

• 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.
• Life expectancy < 2 years.
• Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
• Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent.
• Participation in other trials involving medication or device within 1 month prior to Visit 1.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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