<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03830840</url>
  </required_header>
  <id_info>
    <org_study_id>2017 - 6004</org_study_id>
    <nct_id>NCT03830840</nct_id>
  </id_info>
  <brief_title>Mil Familias Cohort Establishment: a Study to Understand Determinants of Diabetes and Its Complications Among US Latinos</brief_title>
  <official_title>Mil Familias: an Observational Cohort Study to Understand the Impact of Genetics, Biology, Behavior, Psychology, and Society/Environment on Diabetes and Its Complications Among US Latinos</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sansum Diabetes Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sansum Diabetes Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Mil Familias Cohort Establishment involves enrolling 1000 Latino families with at least&#xD;
      one member in the family having type 2 diabetes, including children and youth, and measuring&#xD;
      the 5 determinants of human health: genetics, biology, behavior, psychology, and&#xD;
      society/environment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The vision of Mil Familias is to reduce the burden of cardio-metabolic disease among Latino&#xD;
      families in Santa Barbara County and beyond. The aim is to establish an observational cohort&#xD;
      of 1,000 Latino families, with at least one family member currently living with diabetes, in&#xD;
      order to understand better the impact of the 5 determinants of human health (genetics,&#xD;
      biology, behavior, psychology, and society/environment) in this population. Once the&#xD;
      1,000-family cohort is established, evidence-based intervention studies will be developed and&#xD;
      implemented based on new knowledge, with collaborators from the healthcare, public policy,&#xD;
      academic, pharmaceutical, medical device and technology industries. The strategy involves 4&#xD;
      coordinated and iterative components to achieve its mission:&#xD;
&#xD;
        1. Especialistas: Trusted, bilingual community health workers specially-trained in diabetes&#xD;
           education, clinical research methodologies, and care referral. The Especialistas will&#xD;
           engage directly with participants to conduct research activities, answer questions, and&#xD;
           when necessary, refer participants to appropriate, local community resources.&#xD;
&#xD;
        2. Data: Facilitated by Especialistas, each individual participant will contribute&#xD;
           information on up to 100 different variables relating to their genetics, biology,&#xD;
           psychology, behavior and society/environment, thus creating a one-of-a-kind database and&#xD;
           associated specimen biobank on Latino health and lifestyle (&quot;Living Information Bank&quot;).&#xD;
&#xD;
        3. Interventions: Based on the data, evidence-based, collaborative, culturally-relevant&#xD;
           prevention and treatment strategies are planned to develop once the cohort of 1,000&#xD;
           families has been established.&#xD;
&#xD;
        4. Allies: This community-based participatory research study requires engagement from key&#xD;
           stakeholders from the Latino community, healthcare sectors, hospitals, payers,&#xD;
           businesses, people with diabetes and philanthropists. Organizations and individuals&#xD;
           support Mil Familias by contributing their resources, experiences, and skill-sets.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">March 29, 2022</completion_date>
  <primary_completion_date type="Actual">March 29, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Success (evaluated by Yes/No format) recruiting and establishing an observational cohort of 1,000 Latino families with at least one family member living with type 2 diabetes by deploying the methods proven feasible by Mil Familias Operational Pilot.</measure>
    <time_frame>3 years</time_frame>
    <description>The Mil Familias Cohort Establishment will expand upon the Mil Familias Operational Pilot cohort and infrastructure to collect and store the up to 100 proposed variables across the 5 determinants of human health to support long-term Mil Familias implementation. The variables pertaining to each participant will be collected and stored at the initial visit and then annually for up to 3 years. Socio-demographic characteristics of the cohort will be described at enrollment by type 2 diabetes status, including age, gender, self-identified race/ethnicity, number of people in household, education, insurance, income, occupation, HbA1c, and country of birth.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Socio-demographics assessed by questionnaire.</measure>
    <time_frame>Introductory interview/ demographics/ contacts and annually up to 3 years</time_frame>
    <description>Socio-demographics measured by questionnaire - including age, gender, self-identified race/ethnicity, contact information, number in household, income, education, marital status, occupation, caring for elder, night shifts, insurance status, insurance type and payer, influenza immunization status, immigration status, alcohol &amp; tobacco use, birth place,and duration of time in the United States (&lt;5 years, 5-9 years, 10-14 years, 15-19 years, 20-24 years, ≥25 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of healthcare visits and the difficulty in traveling to the healthcare provider assessed by questionnaire</measure>
    <time_frame>Introductory interview/ demographics/ contacts and annually up to 3 years</time_frame>
    <description>Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by interview questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions</measure>
    <time_frame>Introductory interview/ demographics/ contacts and annually up to 3 years</time_frame>
    <description>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?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total daily tortilla consumption</measure>
    <time_frame>Introductory interview/ demographics/ contacts and annually up to 3 years</time_frame>
    <description>The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily sugary drink consumption</measure>
    <time_frame>Introductory interview/ demographics/ contacts and annually up to 3 years</time_frame>
    <description>Daily sugary drink consumption is measured by the 2 questions in the Sugar Sweetened Beverages module of the Behavioral Risk Factor Surveillance System Questionnaire from the Centers for Disease Control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times per week eating meals prepared away from home</measure>
    <time_frame>Introductory interview/ demographics/ contacts and annually up to 3 years</time_frame>
    <description>NHANES 2017-2018 question asked - During the past 7 days, how many meals did you get that were prepared away from home in places such as restaurants, fast food places, food stands, grocery stores, or from vending machines?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of C-Peptide related to diabetes</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>C-Peptide, ng/mL, will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of C-Reactive protein related to diabetes</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>C-Reactive protein, mg/L, will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of Complete Blood Count</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Complete Blood Count will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of Comprehensive Metabolic Panel</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Comprehensive Metabolic Panel will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Glutamic Acid Decarboxylase (GAD) antibodies, U/mL, will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of HbA1c related to diabetes</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>HbA1c % will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Insulin autoantibody, U/mL, will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of Islet antigen 2 (IA-2) antibody related to diabetes</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Islet antigen 2 (IA-2) antibody, U/mL, will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of lipids</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Lipids will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of Insulin</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Insulin, milliunits/L, will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory blood draw for evaluation of thyroid function</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Thyroid function will measured in a laboratory blood draw sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microalbumin measured in a urine sample</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Urine sample collected for measuring microalbumin mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine measured in a urine sample</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Urine sample collected for measuring creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microalbumin/creatinine ratio measured in a urine sample</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Urine sample collected for measuring the microalbumin/creatinine ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cheek cells and saliva for genomic analysis</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Cheek epithelial cells from a swab and saliva samples will be collected for genetic analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool samples for microbiome analysis</measure>
    <time_frame>Laboratory encounter and annually up to 3 years</time_frame>
    <description>Stool/fecal samples will be collected for microbiome analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height measured by Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Height measured in centimeters or inches by physical exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight measured by Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Weight measured in kilograms or pounds by physical exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference measured by Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Waist circumference measured in centimeters or inches by physical exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure measured by Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Blood pressure, systolic and diastolic, measured in mmHg by physical exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature measured by Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Temperature measured in degrees by physical exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate measured by Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Heart rate measured in beats per minute by physical exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot examination evaluated by Questions and Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Foot examination with yes or no questions and by physical exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy Questions during Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Questions about neuropathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinopathy questions during Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Questions about retinopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dental exam Questions during Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Questions about dental exams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eye exam Questions during Physical exam</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Questions about eye exams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical history, family medical history, and medication status and history assessed by interview</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Medical history including date of diabetes diagnosis, family medical history, and current medications verified by visual inspection and medication history assessed by interview questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview</measure>
    <time_frame>Physical exam encounter and annually up to 3 years</time_frame>
    <description>Menopausal status, pregnancy status (number of live births, number of stillbirths, birthweights of live births, and any diagnosis of type 1 diabetes), and gestational diabetes history for female participants will be determined by interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of diabetes related foot disease</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>Questionnaire for determination of diabetes related foot disease (Q-DFD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)</measure>
    <time_frame>Questionnaire encounter and annually up to 3 years</time_frame>
    <description>BASH is a participant reported questionnaire to measure acculturation. Responses are scored as 1 = only Spanish, 2 = Spanish more than English, 3 = Spanish and English equally, 4 = English more than Spanish, and 5 = only English. Items are summed and divided by the number of items. Low acculturation is less than or equal to 3.0, and high acculturation is greater than or equal to 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by the Short Form Health Survey (SF-12)</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>The SF-12 is a participant reported questionnaire to measure quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression measured by the Patient Health Questionnaire-9</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>The Patient Health Questionnaire (PHQ)-9 is the Major Depressive Disorder (MDD) module of the full PHQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>PEDQ-CV is a participant reported questionnaire to measure perceived ethnic discrimination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Childhood Experiences (ACE) quantified by ACE questionnaire</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>Adverse Childhood Experiences (ACEs) refers to a range of events that a child can experience, which lead to stress and can result in trauma and chronic stress responses. An ACE score will be quantified by a specific ACE questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirituality measured by a Spiritual Well Being Scale</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>FACIT&quot; (Functional Assessment of Chronic Illness Therapy) Sp-12 is a questionnaire for measuring spiritual well being. Questions are scored from 0 = Not at all to 4 = Very much. Sub-scales are created for meaning, peace, and faith with score ranges of 0 - 16. Adding these 3 scores gives a total score and the range is 0 - 48 with low scores indicating low spiritual well being and high scores indicating higher spiritual well being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk Perception Survey For Developing Diabetes (RPS-DD)</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>Diabetes risk perception will be measured by the Risk Perception Survey For Developing Diabetes (RPS-DD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>The OSQ is a participant reported questionnaire to measure sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress measured by the 4 item Perceived Stress Scale (PSS)</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>PSS is a participant reported questionnaire to measure stress. The scale ranges from 0 = never to 4 = very often. The final score ranges from 0 - 16, with higher scores indicating more stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes management measured by the Diabetes Symptom Self-Care Inventory</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>Ability to manage diabetes self-care assessed by the Diabetes Symptom Self-Care Inventory (DSSCI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family diabetes management measured by questionnaire</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>Family diabetes Self-Efficacy for management of diabetes measured by questionnaire (FSE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot self care confidence measured by questionnaire</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>Foot Care Confidence Scale (FCCS) is an instrument designed to measure the confidence (self-efficacy) of individuals with type 2 diabetes to perform foot self care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health literacy measured by the Short Assessment of Health Literacy (SAHL)</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>SAHL is a participant reported questionnaire to measure health literacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of health numeracy</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>Newest Vital Sign (NVS) is a tool to assess health literacy and numeracy in English and Spanish</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trust in physician measured by the Trust in Physician (TPS) questionnaire</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>The TPS is a questionnaire and scale to determine trust in the physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social needs screening assessed by the Health Leads Screening toolkit</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>The Health Leads Screening tookit (Boston, MA) will be used to determine social needs - housing instability, childcare, utility needs, financial resource strain, transportation, and exposure to violence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food security assessed by U.S. Household Food Security Survey Module: Six-item short form</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional support measured by the SSQ6</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>Social Support Questionnaire - Short Form (SSQ6) measures functional social support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Support structure measured by Medical Outcomes Study Social Support Survey (mMOS-SS)</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>The eight-item modified Medical Outcomes Study Social Support Survey (mMOS-SS) measures support structure by counting the number of people supporting and satisfaction with that support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National survey of children's health (NSCH) for all children and youth</measure>
    <time_frame>Questionnaires encounter and annually up to 3 years</time_frame>
    <description>The NSCH, a validated survey of children's health and translated into Spanish, will assess health of children and youth</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical activity measured by two wearable physical activity monitors for 1 week</measure>
    <time_frame>On-going activity encounter up to twice in 1 year</time_frame>
    <description>Participants wear an ActiGraph and Fitbit activity monitors simultaneously for 1 week, complete an activity log, and answer a user experience questionnaire.</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">405</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Adult Individuals with Type 2 diabetes</arm_group_label>
    <description>Individuals ≥18 years of Hispanic/Latino heritage with an established diagnosis of type 2 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Family member</arm_group_label>
    <description>Adult family members, ≥18 years, of the individual with type 2 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child family member with diabetes</arm_group_label>
    <description>Child, ≥7 years but &lt;18 years, family member with diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child family member without diabetes</arm_group_label>
    <description>Child, ≥7 years but &lt;18 years, family member without diabetes</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma, buffy coat (white cells), saliva, feces, urine, cheek cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 1,200 families may be screened and enrolled with the prediction of 20% screen-fail or&#xD;
        dropout and 1,000 families enrolled in the study. A &quot;family&quot; will be followed as one unit&#xD;
        but is estimated to include on average 3 to 5 individuals based on the findings from the&#xD;
        Operational Pilot. Up to 6,000 individuals may be enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females ≥ 7 years of age at enrollment.&#xD;
&#xD;
          2. Self-reported Latino heritage.&#xD;
&#xD;
          3. Co-resides with immediate family member (as defined above) OR self with established&#xD;
             diagnosis of Type 2 Diabetes for at least one year prior to enrollment date.&#xD;
&#xD;
          4. Signed and dated written informed consent by the date of enrollment.&#xD;
&#xD;
          5. Based on the research staff's judgment, subject or subject's representative must have&#xD;
             a good understanding, ability, and willingness to adhere to the protocol, including&#xD;
             performance of self-monitored data collection during the wearable device portion.&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Life expectancy &lt; 6 months.&#xD;
&#xD;
          2. Any active clinically significant physical or mental disease or disorder, which in the&#xD;
             investigator's opinion could interfere with the participation of the trial.&#xD;
&#xD;
          3. Language barriers precluding comprehension of study activities and informed consent.&#xD;
&#xD;
          4. Participation in other trials involving medication or device within 1 month prior to&#xD;
             enrollment.&#xD;
&#xD;
          5. Known or suspected abuse of alcohol, narcotics, or illicit drugs. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Kerr, MBChB DM FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sansum Diabetes Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sansum Diabetes Research Institute</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>June 2, 2022</last_update_submitted>
  <last_update_submitted_qc>June 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Cardio-metabolic disease</keyword>
  <keyword>Latino/Hispanic</keyword>
  <keyword>Especialista</keyword>
  <keyword>Community health worker</keyword>
  <keyword>Social determinants of health</keyword>
  <keyword>LatinX</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All individual participant data (IPD) that underlie results in publications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be made available after the primary publication of each analysis.</ipd_time_frame>
    <ipd_access_criteria>Data Sharing Agreements will be formulated by a committee of study investigators and community and industry partners.</ipd_access_criteria>
    <ipd_url>http://www.milfamilias.com</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830840
org study id: 2017 - 6004
nct id: NCT03830840
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Mil Familias Cohort Establishment involves enrolling 1000 Latino families with at least
      one member in the family having type 2 diabetes, including children and youth, and measuring
      the 5 determinants of human health: genetics, biology, behavior, psychology, and
      society/environment.
The vision of Mil Familias is to reduce the burden of cardio-metabolic disease among Latino
      families in Santa Barbara County and beyond. The aim is to establish an observational cohort
      of 1,000 Latino families, with at least one family member currently living with diabetes, in
      order to understand better the impact of the 5 determinants of human health (genetics,
      biology, behavior, psychology, and society/environment) in this population. Once the
      1,000-family cohort is established, evidence-based intervention studies will be developed and
      implemented based on new knowledge, with collaborators from the healthcare, public policy,
      academic, pharmaceutical, medical device and technology industries. The strategy involves 4
      coordinated and iterative components to achieve its mission:

        1. Especialistas: Trusted, bilingual community health workers specially-trained in diabetes
           education, clinical research methodologies, and care referral. The Especialistas will
           engage directly with participants to conduct research activities, answer questions, and
           when necessary, refer participants to appropriate, local community resources.

        2. Data: Facilitated by Especialistas, each individual participant will contribute
           information on up to 100 different variables relating to their genetics, biology,
           psychology, behavior and society/environment, thus creating a one-of-a-kind database and
           associated specimen biobank on Latino health and lifestyle ("Living Information Bank").

        3. Interventions: Based on the data, evidence-based, collaborative, culturally-relevant
           prevention and treatment strategies are planned to develop once the cohort of 1,000
           families has been established.

        4. Allies: This community-based participatory research study requires engagement from key
           stakeholders from the Latino community, healthcare sectors, hospitals, payers,
           businesses, people with diabetes and philanthropists. Organizations and individuals
           support Mil Familias by contributing their resources, experiences, and skill-sets.
observational model: Cohort
time perspective: Cross-Sectional
measure: Success (evaluated by Yes/No format) recruiting and establishing an observational cohort of 1,000 Latino families with at least one family member living with type 2 diabetes by deploying the methods proven feasible by Mil Familias Operational Pilot.
time frame: 3 years
description: The Mil Familias Cohort Establishment will expand upon the Mil Familias Operational Pilot cohort and infrastructure to collect and store the up to 100 proposed variables across the 5 determinants of human health to support long-term Mil Familias implementation. The variables pertaining to each participant will be collected and stored at the initial visit and then annually for up to 3 years. Socio-demographic characteristics of the cohort will be described at enrollment by type 2 diabetes status, including age, gender, self-identified race/ethnicity, number of people in household, education, insurance, income, occupation, HbA1c, and country of birth.
measure: Socio-demographics assessed by questionnaire.
time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
description: Socio-demographics measured by questionnaire - including age, gender, self-identified race/ethnicity, contact information, number in household, income, education, marital status, occupation, caring for elder, night shifts, insurance status, insurance type and payer, influenza immunization status, immigration status, alcohol & tobacco use, birth place,and duration of time in the United States (<5 years, 5-9 years, 10-14 years, 15-19 years, 20-24 years, ≥25 years).
measure: Number of healthcare visits and the difficulty in traveling to the healthcare provider assessed by questionnaire
time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
description: Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by interview questionnaire
measure: Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions
time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
description: 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?
measure: Total daily tortilla consumption
time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
description: The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated
measure: Daily sugary drink consumption
time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
description: Daily sugary drink consumption is measured by the 2 questions in the Sugar Sweetened Beverages module of the Behavioral Risk Factor Surveillance System Questionnaire from the Centers for Disease Control.
measure: Number of times per week eating meals prepared away from home
time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
description: NHANES 2017-2018 question asked - During the past 7 days, how many meals did you get that were prepared away from home in places such as restaurants, fast food places, food stands, grocery stores, or from vending machines?
measure: Laboratory blood draw for evaluation of C-Peptide related to diabetes
time frame: Laboratory encounter and annually up to 3 years
description: C-Peptide, ng/mL, will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of C-Reactive protein related to diabetes
time frame: Laboratory encounter and annually up to 3 years
description: C-Reactive protein, mg/L, will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of Complete Blood Count
time frame: Laboratory encounter and annually up to 3 years
description: Complete Blood Count will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of Comprehensive Metabolic Panel
time frame: Laboratory encounter and annually up to 3 years
description: Comprehensive Metabolic Panel will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes
time frame: Laboratory encounter and annually up to 3 years
description: Glutamic Acid Decarboxylase (GAD) antibodies, U/mL, will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of HbA1c related to diabetes
time frame: Laboratory encounter and annually up to 3 years
description: HbA1c % will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes
time frame: Laboratory encounter and annually up to 3 years
description: Insulin autoantibody, U/mL, will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of Islet antigen 2 (IA-2) antibody related to diabetes
time frame: Laboratory encounter and annually up to 3 years
description: Islet antigen 2 (IA-2) antibody, U/mL, will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of lipids
time frame: Laboratory encounter and annually up to 3 years
description: Lipids will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of Insulin
time frame: Laboratory encounter and annually up to 3 years
description: Insulin, milliunits/L, will measured in a laboratory blood draw sample.
measure: Laboratory blood draw for evaluation of thyroid function
time frame: Laboratory encounter and annually up to 3 years
description: Thyroid function will measured in a laboratory blood draw sample.
measure: Microalbumin measured in a urine sample
time frame: Laboratory encounter and annually up to 3 years
description: Urine sample collected for measuring microalbumin mg/L
measure: Creatinine measured in a urine sample
time frame: Laboratory encounter and annually up to 3 years
description: Urine sample collected for measuring creatinine
measure: Microalbumin/creatinine ratio measured in a urine sample
time frame: Laboratory encounter and annually up to 3 years
description: Urine sample collected for measuring the microalbumin/creatinine ratio
measure: Cheek cells and saliva for genomic analysis
time frame: Laboratory encounter and annually up to 3 years
description: Cheek epithelial cells from a swab and saliva samples will be collected for genetic analysis
measure: Stool samples for microbiome analysis
time frame: Laboratory encounter and annually up to 3 years
description: Stool/fecal samples will be collected for microbiome analysis
measure: Height measured by Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Height measured in centimeters or inches by physical exam
measure: Weight measured by Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Weight measured in kilograms or pounds by physical exam
measure: Waist circumference measured by Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Waist circumference measured in centimeters or inches by physical exam
measure: Blood pressure measured by Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Blood pressure, systolic and diastolic, measured in mmHg by physical exam
measure: Temperature measured by Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Temperature measured in degrees by physical exam
measure: Heart rate measured by Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Heart rate measured in beats per minute by physical exam
measure: Foot examination evaluated by Questions and Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Foot examination with yes or no questions and by physical exam
measure: Neuropathy Questions during Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Questions about neuropathy
measure: Retinopathy questions during Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Questions about retinopathy
measure: Dental exam Questions during Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Questions about dental exams
measure: Eye exam Questions during Physical exam
time frame: Physical exam encounter and annually up to 3 years
description: Questions about eye exams
measure: Medical history, family medical history, and medication status and history assessed by interview
time frame: Physical exam encounter and annually up to 3 years
description: Medical history including date of diabetes diagnosis, family medical history, and current medications verified by visual inspection and medication history assessed by interview questionnaire
measure: Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview
time frame: Physical exam encounter and annually up to 3 years
description: Menopausal status, pregnancy status (number of live births, number of stillbirths, birthweights of live births, and any diagnosis of type 1 diabetes), and gestational diabetes history for female participants will be determined by interview
measure: Determination of diabetes related foot disease
time frame: Questionnaires encounter and annually up to 3 years
description: Questionnaire for determination of diabetes related foot disease (Q-DFD)
measure: Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)
time frame: Questionnaire encounter and annually up to 3 years
description: BASH is a participant reported questionnaire to measure acculturation. Responses are scored as 1 = only Spanish, 2 = Spanish more than English, 3 = Spanish and English equally, 4 = English more than Spanish, and 5 = only English. Items are summed and divided by the number of items. Low acculturation is less than or equal to 3.0, and high acculturation is greater than or equal to 3.0.
measure: Quality of life measured by the Short Form Health Survey (SF-12)
time frame: Questionnaires encounter and annually up to 3 years
description: The SF-12 is a participant reported questionnaire to measure quality of life
measure: Depression measured by the Patient Health Questionnaire-9
time frame: Questionnaires encounter and annually up to 3 years
description: The Patient Health Questionnaire (PHQ)-9 is the Major Depressive Disorder (MDD) module of the full PHQ
measure: Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)
time frame: Questionnaires encounter and annually up to 3 years
description: PEDQ-CV is a participant reported questionnaire to measure perceived ethnic discrimination
measure: Adverse Childhood Experiences (ACE) quantified by ACE questionnaire
time frame: Questionnaires encounter and annually up to 3 years
description: Adverse Childhood Experiences (ACEs) refers to a range of events that a child can experience, which lead to stress and can result in trauma and chronic stress responses. An ACE score will be quantified by a specific ACE questionnaire.
measure: Spirituality measured by a Spiritual Well Being Scale
time frame: Questionnaires encounter and annually up to 3 years
description: FACIT" (Functional Assessment of Chronic Illness Therapy) Sp-12 is a questionnaire for measuring spiritual well being. Questions are scored from 0 = Not at all to 4 = Very much. Sub-scales are created for meaning, peace, and faith with score ranges of 0 - 16. Adding these 3 scores gives a total score and the range is 0 - 48 with low scores indicating low spiritual well being and high scores indicating higher spiritual well being.
measure: Risk Perception Survey For Developing Diabetes (RPS-DD)
time frame: Questionnaires encounter and annually up to 3 years
description: Diabetes risk perception will be measured by the Risk Perception Survey For Developing Diabetes (RPS-DD)
measure: Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)
time frame: Questionnaires encounter and annually up to 3 years
description: The OSQ is a participant reported questionnaire to measure sleep quality
measure: Stress measured by the 4 item Perceived Stress Scale (PSS)
time frame: Questionnaires encounter and annually up to 3 years
description: PSS is a participant reported questionnaire to measure stress. The scale ranges from 0 = never to 4 = very often. The final score ranges from 0 - 16, with higher scores indicating more stress.
measure: Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20
time frame: Questionnaires encounter and annually up to 3 years
description: 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
measure: Diabetes management measured by the Diabetes Symptom Self-Care Inventory
time frame: Questionnaires encounter and annually up to 3 years
description: Ability to manage diabetes self-care assessed by the Diabetes Symptom Self-Care Inventory (DSSCI)
measure: Family diabetes management measured by questionnaire
time frame: Questionnaires encounter and annually up to 3 years
description: Family diabetes Self-Efficacy for management of diabetes measured by questionnaire (FSE)
measure: Foot self care confidence measured by questionnaire
time frame: Questionnaires encounter and annually up to 3 years
description: Foot Care Confidence Scale (FCCS) is an instrument designed to measure the confidence (self-efficacy) of individuals with type 2 diabetes to perform foot self care
measure: Health literacy measured by the Short Assessment of Health Literacy (SAHL)
time frame: Questionnaires encounter and annually up to 3 years
description: SAHL is a participant reported questionnaire to measure health literacy
measure: Measurement of health numeracy
time frame: Questionnaires encounter and annually up to 3 years
description: Newest Vital Sign (NVS) is a tool to assess health literacy and numeracy in English and Spanish
measure: Trust in physician measured by the Trust in Physician (TPS) questionnaire
time frame: Questionnaires encounter and annually up to 3 years
description: The TPS is a questionnaire and scale to determine trust in the physician
measure: Social needs screening assessed by the Health Leads Screening toolkit
time frame: Questionnaires encounter and annually up to 3 years
description: The Health Leads Screening tookit (Boston, MA) will be used to determine social needs - housing instability, childcare, utility needs, financial resource strain, transportation, and exposure to violence.
measure: Food security assessed by U.S. Household Food Security Survey Module: Six-item short form
time frame: Questionnaires encounter and annually up to 3 years
description: 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
measure: Functional support measured by the SSQ6
time frame: Questionnaires encounter and annually up to 3 years
description: Social Support Questionnaire - Short Form (SSQ6) measures functional social support
measure: Support structure measured by Medical Outcomes Study Social Support Survey (mMOS-SS)
time frame: Questionnaires encounter and annually up to 3 years
description: The eight-item modified Medical Outcomes Study Social Support Survey (mMOS-SS) measures support structure by counting the number of people supporting and satisfaction with that support
measure: National survey of children's health (NSCH) for all children and youth
time frame: Questionnaires encounter and annually up to 3 years
description: The NSCH, a validated survey of children's health and translated into Spanish, will assess health of children and youth
measure: Physical activity measured by two wearable physical activity monitors for 1 week
time frame: On-going activity encounter up to twice in 1 year
description: Participants wear an ActiGraph and Fitbit activity monitors simultaneously for 1 week, complete an activity log, and answer a user experience questionnaire.
arm group label: Adult Individuals with Type 2 diabetes
description: Individuals ≥18 years of Hispanic/Latino heritage with an established diagnosis of type 2 diabetes
arm group label: Adult Family member
description: Adult family members, ≥18 years, of the individual with type 2 diabetes
arm group label: Child family member with diabetes
description: Child, ≥7 years but <18 years, family member with diabetes
arm group label: Child family member without diabetes
description: Child, ≥7 years but <18 years, family member without diabetes
Serum, plasma, buffy coat (white cells), saliva, feces, urine, cheek cells
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Kerr, MBChB DM FRCP
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: All individual participant data (IPD) that underlie results in publications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be made available after the primary publication of each analysis.
ipd access criteria: Data Sharing Agreements will be formulated by a committee of study investigators and community and industry partners.
ipd url: http://www.milfamilias.com