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

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.

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).

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

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?

The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated

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.

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?

C-Peptide, ng/mL, will measured in a laboratory blood draw sample.

C-Reactive protein, mg/L, will measured in a laboratory blood draw sample.

Complete Blood Count will measured in a laboratory blood draw sample.

Comprehensive Metabolic Panel will measured in a laboratory blood draw sample.

Glutamic Acid Decarboxylase (GAD) antibodies, U/mL, will measured in a laboratory blood draw sample.

HbA1c % will measured in a laboratory blood draw sample.

Insulin autoantibody, U/mL, will measured in a laboratory blood draw sample.

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

Lipids will measured in a laboratory blood draw sample.

Insulin, milliunits/L, will measured in a laboratory blood draw sample.

Thyroid function will measured in a laboratory blood draw sample.

Urine sample collected for measuring microalbumin mg/L

Urine sample collected for measuring creatinine

Urine sample collected for measuring the microalbumin/creatinine ratio

Cheek epithelial cells from a swab and saliva samples will be collected for genetic analysis

Stool/fecal samples will be collected for microbiome analysis

Height measured in centimeters or inches by physical exam

Weight measured in kilograms or pounds by physical exam

Waist circumference measured in centimeters or inches by physical exam

Blood pressure, systolic and diastolic, measured in mmHg by physical exam

Temperature measured in degrees by physical exam

Heart rate measured in beats per minute by physical exam

Foot examination with yes or no questions and by physical exam

Questions about neuropathy

Questions about retinopathy

Questions about dental exams

Questions about eye exams

Medical history including date of diabetes diagnosis, family medical history, and current medications verified by visual inspection and medication history assessed by interview questionnaire

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

Questionnaire for determination of diabetes related foot disease (Q-DFD)

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.

The SF-12 is a participant reported questionnaire to measure quality of life

The Patient Health Questionnaire (PHQ)-9 is the Major Depressive Disorder (MDD) module of the full PHQ

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

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.

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.

Diabetes risk perception will be measured by the Risk Perception Survey For Developing Diabetes (RPS-DD)

The OSQ is a participant reported questionnaire to measure sleep quality

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.

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

Ability to manage diabetes self-care assessed by the Diabetes Symptom Self-Care Inventory (DSSCI)

Family diabetes Self-Efficacy for management of diabetes measured by questionnaire (FSE)

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

SAHL is a participant reported questionnaire to measure health literacy

Newest Vital Sign (NVS) is a tool to assess health literacy and numeracy in English and Spanish

The TPS is a questionnaire and scale to determine trust in the physician

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.

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

Social Support Questionnaire - Short Form (SSQ6) measures functional social support

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

The NSCH, a validated survey of children's health and translated into Spanish, will assess health of children and youth

Participants wear an ActiGraph and Fitbit activity monitors simultaneously for 1 week, complete an activity log, and answer a user experience questionnaire.