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

Sansum Diabetes Research Institute

Status: Completed

Conditions: Type2 Diabetes Mellitus; Cardiovascular Diseases

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03736486

2017-5864

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Type 2 Diabetes

Description:

Male and female adults of Hispanic and/or Latino heritage with an established diagnosis of Type 2 diabetes.