Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
NCT Number: NCT03736486
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.
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Notify Me18 year and older
All sexes
Observational
Santa Barbara, California, 93105, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Mil Familias Program Pilot will measure genetic influences by a family medical history & biobank blood samples. Biologic influences will include laboratory blood draw, physical exam with vital signs & waist circumference measurement, and complete medical & medication history with female menopause, pregnancy, & gestational diabetes status. Behavior influences will include sleep, stress, drug abuse, and diabetes self-assessment management questionnaires. Wearable devices will measure physical activity. Psychological influences will include Patient Health Questionnaire-9, Brief Perceived Ethnic Discrimination Questionnaire Community Version, and Short Form Health Survey. Social/environmental influences will include socio-demographics, Brief Acculturation Scale for Hispanics, personal opinions about type 2 diabetes, and questionnaires [Short Assessment of Health Literacy, Trust in Physician, Health Leads Screening Toolkit, and U.S. Household Food Security Survey].
Time frame: Beginning of study - Baseline visit 1
Socio-demographics assessed by questionnaire.
Time frame: Beginning of study - Baseline visit 1
Participant report and self-assessment of diabetes management by questionnaire
Time frame: Beginning of study - Baseline visit 1
Food security or insecurity assessed by a six-item short form developed by the Economic Research Service, United States Department of Agriculture (USDA), September 2012
Time frame: Beginning of study - Baseline visit 1
The Health Leads Screening Tookit (Boston, MA) will be used to determine social needs
Time frame: Beginning of study - Baseline visit 1
Number of healthcare visits assessed in medical record review and the difficulty in traveling to the healthcare provider assessed by questionnaire
Time frame: Beginning of study - Baseline visit 1
Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions
Time frame: Beginning of study - Baseline visit 1
How well a participant is supported in diabetes care measured by a questionnaire from the American Diabetes Association (ADA) Participant Self-Assessment of Diabetes Management questionnaire
Time frame: Day 1 of Visit 2
Medical history, family medical history, and current medications and medication history assessed by interview and electronic medical records
Time frame: Day 1 of Visit 2
Menopausal status, pregnancy status, and gestational diabetes history for female participants will be determined by interview and electronic medical records
Time frame: Day 1 of Visit 2
Physical exam with vital signs and questions about neuropathy, retinopathy, dental, and eye exams
Time frame: Day 1 of Visit 2
Laboratory blood draw for evaluation of physiological markers related to diabetes
Time frame: Day 1 of Visit 2
Urine sample collected for measuring microalbumin, creatinine, and the microalbumin/creatinine ratio
Time frame: Day 1 of Visit 2
The Patient Health Questionnaire (PHQ)-9 is the Major Depressive Disorder (MDD) module of the full PHQ
Time frame: Day 1 of Visit 2
The purpose of the DAST-20 is to provide a brief, simple, practical, but valid method for identifying individuals who are abusing psychoactive drugs; and to yield a quantitative index score of the degree of problems related to drug use and misuse
Time frame: 1 week
Participants wear an ActiGraph and Fitbit activity monitors simultaneously for 1 week
Time frame: Day 1 of Visit 3
BASH is a participant reported questionnaire to measure acculturation
Time frame: Day 1 of Visit 3
SAHL is a participant reported questionnaire to measure health literacy
Time frame: Day 1 of Visit 3
PEDQ-CV is a participant reported questionnaire to measure perceived ethnic discrimination
Time frame: Day 1 of Visit 3
PSS is a participant reported questionnaire to measure stress
Time frame: Day 1 of Visit 3
The SF-12 is a participant reported questionnaire to measure quality of life
Time frame: Day 1 of Visit 3
The OSQ is a participant reported questionnaire to measure sleep quality
Time frame: Day 1 of Visit 3
The TPS is a questionnaire and scale to determine trust in the physician
Time frame: 1 year
A local consortium of partners will be engaged with formal operational partnerships that include signed agreements and statements of work. These partnerships will include local health clinics and providers, the county, Hispanic/Latino community groups, other non-profit groups involved with the Hispanic/Latino community, and health promoters such as the Young Men's Christian Association (YMCA).
Time frame: 1 year
Curricula will be developed, delivered, and evaluated by the number of health workers trained & employed and the number of encounters between participants & trained health workers (Especialistas). Three modules of training curriculum will be developed for Type 2 Diabetes (T2D) Educators, Researchers, and Care Navigators. Training includes T2D clinical aspects, health determinants, diabetes education for Latinos, technology integration into diabetes education, focused diabetes education, research fundamentals, Good Clinical Practice, human subjects protections, participant recruitment, selection & enrollment, clinical data collection, qualitative data collection methods, technology to enhance & facilitate diabetes research, health care sequence, diabetes resources, social and health care resources, health insurance coverage & eligibility, making referrals to resources, sociocultural insight to diabetes care navigation, and technology facilitate access to resources.
Sansum Diabetes Research Institute
Other
Mil Familias- Santa Barbara Operational Pilot
Acronym: MilFamilias
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