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Mil Familias Cohort Establishment: a Study to Understand Determinants of Diabetes and Its Complications Among US Latinos

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ClinicalTrials.gov Identifier: NCT03830840
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

Brief Summary:
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.

Condition or disease
Type2 Diabetes Mellitus Cardiovascular Diseases

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Adult Individuals with Type 2 diabetes
Individuals ≥18 years of Hispanic/Latino heritage with an established diagnosis of type 2 diabetes
Adult Family member
Adult family members, ≥18 years, of the individual with type 2 diabetes
Child family member with diabetes
Child, ≥7 years but <18 years, family member with diabetes
Child family member without diabetes
Child, ≥7 years but <18 years, family member without diabetes



Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Socio-demographics assessed by questionnaire. [ Time Frame: Introductory interview/ demographics/ contacts and annually up to 3 years ]
    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).

  2. 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 ]
    Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by interview questionnaire

  3. 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 ]
    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?

  4. Total daily tortilla consumption [ Time Frame: Introductory interview/ demographics/ contacts and annually up to 3 years ]
    The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated

  5. Daily sugary drink consumption [ Time Frame: Introductory interview/ demographics/ contacts and annually up to 3 years ]
    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.

  6. Number of times per week eating meals prepared away from home [ Time Frame: Introductory interview/ demographics/ contacts and annually up to 3 years ]
    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?

  7. Laboratory blood draw for evaluation of C-Peptide related to diabetes [ Time Frame: Laboratory encounter and annually up to 3 years ]
    C-Peptide, ng/mL, will measured in a laboratory blood draw sample.

  8. Laboratory blood draw for evaluation of C-Reactive protein related to diabetes [ Time Frame: Laboratory encounter and annually up to 3 years ]
    C-Reactive protein, mg/L, will measured in a laboratory blood draw sample.

  9. Laboratory blood draw for evaluation of Complete Blood Count [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Complete Blood Count will measured in a laboratory blood draw sample.

  10. Laboratory blood draw for evaluation of Comprehensive Metabolic Panel [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Comprehensive Metabolic Panel will measured in a laboratory blood draw sample.

  11. Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Glutamic Acid Decarboxylase (GAD) antibodies, U/mL, will measured in a laboratory blood draw sample.

  12. Laboratory blood draw for evaluation of HbA1c related to diabetes [ Time Frame: Laboratory encounter and annually up to 3 years ]
    HbA1c % will measured in a laboratory blood draw sample.

  13. Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Insulin autoantibody, U/mL, will measured in a laboratory blood draw sample.

  14. 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 ]
    Islet antigen 2 (IA-2) antibody, U/mL, will measured in a laboratory blood draw sample.

  15. Laboratory blood draw for evaluation of lipids [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Lipids will measured in a laboratory blood draw sample.

  16. Laboratory blood draw for evaluation of Insulin [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Insulin, milliunits/L, will measured in a laboratory blood draw sample.

  17. Laboratory blood draw for evaluation of thyroid function [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Thyroid function will measured in a laboratory blood draw sample.

  18. Microalbumin measured in a urine sample [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Urine sample collected for measuring microalbumin mg/L

  19. Creatinine measured in a urine sample [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Urine sample collected for measuring creatinine

  20. Microalbumin/creatinine ratio measured in a urine sample [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Urine sample collected for measuring the microalbumin/creatinine ratio

  21. Cheek cells and saliva for genomic analysis [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Cheek epithelial cells from a swab and saliva samples will be collected for genetic analysis

  22. Stool samples for microbiome analysis [ Time Frame: Laboratory encounter and annually up to 3 years ]
    Stool/fecal samples will be collected for microbiome analysis

  23. Height measured by Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Height measured in centimeters or inches by physical exam

  24. Weight measured by Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Weight measured in kilograms or pounds by physical exam

  25. Waist circumference measured by Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Waist circumference measured in centimeters or inches by physical exam

  26. Blood pressure measured by Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Blood pressure, systolic and diastolic, measured in mmHg by physical exam

  27. Temperature measured by Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Temperature measured in degrees by physical exam

  28. Heart rate measured by Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Heart rate measured in beats per minute by physical exam

  29. Foot examination evaluated by Questions and Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Foot examination with yes or no questions and by physical exam

  30. Neuropathy Questions during Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Questions about neuropathy

  31. Retinopathy questions during Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Questions about retinopathy

  32. Dental exam Questions during Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Questions about dental exams

  33. Eye exam Questions during Physical exam [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Questions about eye exams

  34. Medical history, family medical history, and medication status and history assessed by interview [ Time Frame: Physical exam encounter and annually up to 3 years ]
    Medical history including date of diabetes diagnosis, family medical history, and current medications verified by visual inspection and medication history assessed by interview questionnaire

  35. Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview [ Time Frame: Physical exam encounter and annually up to 3 years ]
    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

  36. Determination of diabetes related foot disease [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    Questionnaire for determination of diabetes related foot disease (Q-DFD)

  37. Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH) [ Time Frame: Questionnaire encounter and annually up to 3 years ]
    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.

  38. Quality of life measured by the Short Form Health Survey (SF-12) [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    The SF-12 is a participant reported questionnaire to measure quality of life

  39. Depression measured by the Patient Health Questionnaire-9 [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    The Patient Health Questionnaire (PHQ)-9 is the Major Depressive Disorder (MDD) module of the full PHQ

  40. 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 ]
    PEDQ-CV is a participant reported questionnaire to measure perceived ethnic discrimination

  41. Adverse Childhood Experiences (ACE) quantified by ACE questionnaire [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    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.

  42. Spirituality measured by a Spiritual Well Being Scale [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    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.

  43. Risk Perception Survey For Developing Diabetes (RPS-DD) [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    Diabetes risk perception will be measured by the Risk Perception Survey For Developing Diabetes (RPS-DD)

  44. Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ) [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    The OSQ is a participant reported questionnaire to measure sleep quality

  45. Stress measured by the 4 item Perceived Stress Scale (PSS) [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    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.

  46. Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20 [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    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

  47. Diabetes management measured by the Diabetes Symptom Self-Care Inventory [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    Ability to manage diabetes self-care assessed by the Diabetes Symptom Self-Care Inventory (DSSCI)

  48. Family diabetes management measured by questionnaire [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    Family diabetes Self-Efficacy for management of diabetes measured by questionnaire (FSE)

  49. Foot self care confidence measured by questionnaire [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    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

  50. Health literacy measured by the Short Assessment of Health Literacy (SAHL) [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    SAHL is a participant reported questionnaire to measure health literacy

  51. Measurement of health numeracy [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    Newest Vital Sign (NVS) is a tool to assess health literacy and numeracy in English and Spanish

  52. Trust in physician measured by the Trust in Physician (TPS) questionnaire [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    The TPS is a questionnaire and scale to determine trust in the physician

  53. Social needs screening assessed by the Health Leads Screening toolkit [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    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.

  54. 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 ]
    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

  55. Functional support measured by the SSQ6 [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    Social Support Questionnaire - Short Form (SSQ6) measures functional social support

  56. Support structure measured by Medical Outcomes Study Social Support Survey (mMOS-SS) [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    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

  57. National survey of children's health (NSCH) for all children and youth [ Time Frame: Questionnaires encounter and annually up to 3 years ]
    The NSCH, a validated survey of children's health and translated into Spanish, will assess health of children and youth


Other Outcome Measures:
  1. Physical activity measured by two wearable physical activity monitors for 1 week [ Time Frame: On-going activity encounter up to twice in 1 year ]
    Participants wear an ActiGraph and Fitbit activity monitors simultaneously for 1 week, complete an activity log, and answer a user experience questionnaire.


Biospecimen Retention:   Samples With DNA
Serum, plasma, buffy coat (white cells), saliva, feces, urine, cheek cells


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Up to 1,200 families may be screened and enrolled with the prediction of 20% screen-fail or dropout and 1,000 families enrolled in the study. A "family" will be followed as one unit but is estimated to include on average 3 to 5 individuals based on the findings from the Operational Pilot. Up to 6,000 individuals may be enrolled in this study.
Criteria

Inclusion Criteria:

  1. Males or females ≥ 7 years of age at enrollment.
  2. Self-reported Latino heritage.
  3. Co-resides with immediate family member (as defined above) OR self with established diagnosis of Type 2 Diabetes for at least one year prior to enrollment date.
  4. Signed and dated written informed consent by the date of enrollment.
  5. Based on the research staff's judgment, subject or subject's representative 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. Life expectancy < 6 months.
  2. Any active clinically significant physical or mental disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
  3. Language barriers precluding comprehension of study activities and informed consent.
  4. Participation in other trials involving medication or device within 1 month prior to enrollment.
  5. Known or suspected abuse of alcohol, narcotics, or illicit drugs. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830840


Locations
United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Sansum Diabetes Research Institute
Eli Lilly and Company
Investigators
Principal Investigator: David Kerr, M.D. Sansum Diabetes Research Institute

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT03830840     History of Changes
Other Study ID Numbers: 2017 - 6004
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) that underlie results in publications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be made available after the primary publication of each analysis.
Access Criteria: Data Sharing Agreements will be formulated by a committee of study investigators and community and industry partners.
URL: http://www.milfamilias.com

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sansum Diabetes Research Institute:
Type 2 diabetes
Cardio-metabolic disease
Latino/Hispanic
Especialista
Community health worker
Social determinants of health
LatinX

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases