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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mil Familias- Santa Barbara Operational Pilot

Conditions
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Type2 Diabetes Mellitus, Cardiovascular Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 Diabetes<br>Male and female adults of Hispanic and/or Latino heritage with an established diagnosis of Type 2 diabetes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success (evaluated by Yes/No format) recruiting and establishing a pilot cohort of 100 Latino adults with Type 2 Diabetes and creating data collection methods to describe genetics, biology, behavior, psychology, & environment in Type 2 Diabetes | 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]. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographics measured by questionnaire - including age, gender, race/ethnicity, contact information, number in household, income, education, marital status, occupation, insurance status, immigration status, alcohol & tobacco use, and birth place | Socio-demographics assessed by questionnaire. | Beginning of study - Baseline visit 1 | 
| Self-assessment of diabetes management measured by the American Diabetes Association questionnaire, Participant Self-Assessment of Diabetes Management | Participant report and self-assessment of diabetes management by questionnaire | Beginning of study - Baseline visit 1 | 
| Food security assessed by U.S. Household Food Security Survey Module: Six-item short form | 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 | Beginning of study - Baseline visit 1 | 
| Social needs screening assessed by the Health Leads Screening Toolkit | The Health Leads Screening Tookit (Boston, MA) will be used to determine social needs | Beginning of study - Baseline visit 1 | 
| Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by electronic medical record and interview | Number of healthcare visits assessed in medical record review and the difficulty in traveling to the healthcare provider assessed by questionnaire | Beginning of study - Baseline visit 1 | 
| Personal opinion regarding type 2 diabetes burden on Latinos measured by 3 questions - why is diabetes common in Latinos, what can be done to prevent diabetes in Latinos, and what things make it difficult to get help with diabetes when it is needed? | Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions | Beginning of study - Baseline visit 1 | 
| Support for diabetes care measured by questionnaire adapted from the American Diabetes Association Participant Self-Assessment of Diabetes Management questionnaire | 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 | Beginning of study - Baseline visit 1 | 
| Medical history, family medical history, and medication status and history assessed by interview and electronic medical records | Medical history, family medical history, and current medications and medication history assessed by interview and electronic medical records | Day 1 of Visit 2 | 
| Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview and electronic medical records | Menopausal status, pregnancy status, and gestational diabetes history for female participants will be determined by interview and electronic medical records | Day 1 of Visit 2 | 
| Measurement by composite physical exam - height, weight, waist circumference, blood pressure, temperature, heart rate & rhythm, and foot examination including questions about neuropathy and retinopathy and dental & eye exams | Physical exam with vital signs and questions about neuropathy, retinopathy, dental, and eye exams | Day 1 of Visit 2 | 
| Composite lab tests: C-Peptide, C-reactive protein, Complete blood count, Comprehensive metabolic panel, Glutamic Acid Decarboxylase (GAD) antibodies, HbA1c, Insulin autoantibody, Lipid panel, Insulin, and Thyroid function | Laboratory blood draw for evaluation of physiological markers related to diabetes | Day 1 of Visit 2 | 
| Microalbumin, creatinine, and microalbumin/creatinine ratio measured in a urine sample | Urine sample collected for measuring microalbumin, creatinine, and the microalbumin/creatinine ratio | Day 1 of Visit 2 | 
| Depression measured by the Patient Health Questionnaire-9 | The Patient Health Questionnaire (PHQ)-9 is the Major Depressive Disorder (MDD) module of the full PHQ | Day 1 of Visit 2 | 
| Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20 | 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 | Day 1 of Visit 2 | 
| Physical activity measured by two wearable physical activity monitors for 1 week | Participants wear an ActiGraph and Fitbit activity monitors simultaneously for 1 week | 1 week | 
| Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH) | BASH is a participant reported questionnaire to measure acculturation | Day 1 of Visit 3 | 
| Health literacy measured by the Short Assessment of Health Literacy (SAHL) | SAHL is a participant reported questionnaire to measure health literacy | Day 1 of Visit 3 | 
| Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV) | PEDQ-CV is a participant reported questionnaire to measure perceived ethnic discrimination | Day 1 of Visit 3 | 
| Stress measured by the 4 item Perceived Stress Scale (PSS) | PSS is a participant reported questionnaire to measure stress | Day 1 of Visit 3 | 
| Quality of life measured by the Short Form Health Survey (SF-12) | The SF-12 is a participant reported questionnaire to measure quality of life | Day 1 of Visit 3 | 
| Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ) | The OSQ is a participant reported questionnaire to measure sleep quality | Day 1 of Visit 3 | 
| Trust in physician measured by the Trust in Physician (TPS) questionnaire | The TPS is a questionnaire and scale to determine trust in the physician | Day 1 of Visit 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Cardio-metabolic disease, Latino, Hispanic, Especialista