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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Type2 Diabetes Mellitus

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
• Enrollment (Actual): 405

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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. -

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-demographics assessed by questionnaire.	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).	Introductory interview/ demographics/ contacts and annually up to 3 years
Number of healthcare visits and the difficulty in traveling to the healthcare provider assessed by questionnaire	Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by interview questionnaire	Introductory interview/ demographics/ contacts and annually up to 3 years
Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions	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?	Introductory interview/ demographics/ contacts and annually up to 3 years
Total daily tortilla consumption	The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated	Introductory interview/ demographics/ contacts and annually up to 3 years
Daily sugary drink consumption	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.	Introductory interview/ demographics/ contacts and annually up to 3 years
Number of times per week eating meals prepared away from home	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?	Introductory interview/ demographics/ contacts and annually up to 3 years
Laboratory blood draw for evaluation of C-Peptide related to diabetes	C-Peptide, ng/mL, will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of C-Reactive protein related to diabetes	C-Reactive protein, mg/L, will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Complete Blood Count	Complete Blood Count will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Comprehensive Metabolic Panel	Comprehensive Metabolic Panel will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes	Glutamic Acid Decarboxylase (GAD) antibodies, U/mL, will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of HbA1c related to diabetes	HbA1c % will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes	Insulin autoantibody, U/mL, will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Islet antigen 2 (IA-2) antibody related to diabetes	Islet antigen 2 (IA-2) antibody, U/mL, will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of lipids	Lipids will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Insulin	Insulin, milliunits/L, will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of thyroid function	Thyroid function will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Microalbumin measured in a urine sample	Urine sample collected for measuring microalbumin mg/L	Laboratory encounter and annually up to 3 years
Creatinine measured in a urine sample	Urine sample collected for measuring creatinine	Laboratory encounter and annually up to 3 years
Microalbumin/creatinine ratio measured in a urine sample	Urine sample collected for measuring the microalbumin/creatinine ratio	Laboratory encounter and annually up to 3 years
Cheek cells and saliva for genomic analysis	Cheek epithelial cells from a swab and saliva samples will be collected for genetic analysis	Laboratory encounter and annually up to 3 years
Stool samples for microbiome analysis	Stool/fecal samples will be collected for microbiome analysis	Laboratory encounter and annually up to 3 years
Height measured by Physical exam	Height measured in centimeters or inches by physical exam	Physical exam encounter and annually up to 3 years
Weight measured by Physical exam	Weight measured in kilograms or pounds by physical exam	Physical exam encounter and annually up to 3 years
Waist circumference measured by Physical exam	Waist circumference measured in centimeters or inches by physical exam	Physical exam encounter and annually up to 3 years
Blood pressure measured by Physical exam	Blood pressure, systolic and diastolic, measured in mmHg by physical exam	Physical exam encounter and annually up to 3 years
Temperature measured by Physical exam	Temperature measured in degrees by physical exam	Physical exam encounter and annually up to 3 years
Heart rate measured by Physical exam	Heart rate measured in beats per minute by physical exam	Physical exam encounter and annually up to 3 years
Foot examination evaluated by Questions and Physical exam	Foot examination with yes or no questions and by physical exam	Physical exam encounter and annually up to 3 years
Neuropathy Questions during Physical exam	Questions about neuropathy	Physical exam encounter and annually up to 3 years
Retinopathy questions during Physical exam	Questions about retinopathy	Physical exam encounter and annually up to 3 years
Dental exam Questions during Physical exam	Questions about dental exams	Physical exam encounter and annually up to 3 years
Eye exam Questions during Physical exam	Questions about eye exams	Physical exam encounter and annually up to 3 years
Medical history, family medical history, and medication status and history assessed by interview	Medical history including date of diabetes diagnosis, family medical history, and current medications verified by visual inspection and medication history assessed by interview questionnaire	Physical exam encounter and annually up to 3 years
Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview	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	Physical exam encounter and annually up to 3 years
Determination of diabetes related foot disease	Questionnaire for determination of diabetes related foot disease (Q-DFD)	Questionnaires encounter and annually up to 3 years
Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)	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.	Questionnaire encounter and annually up to 3 years
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	Questionnaires encounter and annually up to 3 years
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	Questionnaires encounter and annually up to 3 years
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	Questionnaires encounter and annually up to 3 years
Adverse Childhood Experiences (ACE) quantified by ACE questionnaire	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.	Questionnaires encounter and annually up to 3 years
Spirituality measured by a Spiritual Well Being Scale	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.	Questionnaires encounter and annually up to 3 years
Risk Perception Survey For Developing Diabetes (RPS-DD)	Diabetes risk perception will be measured by the Risk Perception Survey For Developing Diabetes (RPS-DD)	Questionnaires encounter and annually up to 3 years
Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)	The OSQ is a participant reported questionnaire to measure sleep quality	Questionnaires encounter and annually up to 3 years
Stress measured by the 4 item Perceived Stress Scale (PSS)	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.	Questionnaires encounter and annually up to 3 years
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	Questionnaires encounter and annually up to 3 years
Diabetes management measured by the Diabetes Symptom Self-Care Inventory	Ability to manage diabetes self-care assessed by the Diabetes Symptom Self-Care Inventory (DSSCI)	Questionnaires encounter and annually up to 3 years
Family diabetes management measured by questionnaire	Family diabetes Self-Efficacy for management of diabetes measured by questionnaire (FSE)	Questionnaires encounter and annually up to 3 years
Foot self care confidence measured by questionnaire	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	Questionnaires encounter and annually up to 3 years
Health literacy measured by the Short Assessment of Health Literacy (SAHL)	SAHL is a participant reported questionnaire to measure health literacy	Questionnaires encounter and annually up to 3 years
Measurement of health numeracy	Newest Vital Sign (NVS) is a tool to assess health literacy and numeracy in English and Spanish	Questionnaires encounter and annually up to 3 years
Trust in physician measured by the Trust in Physician (TPS) questionnaire	The TPS is a questionnaire and scale to determine trust in the physician	Questionnaires encounter and annually up to 3 years
Social needs screening assessed by the Health Leads Screening toolkit	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.	Questionnaires encounter and annually up to 3 years
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	Questionnaires encounter and annually up to 3 years
Functional support measured by the SSQ6	Social Support Questionnaire - Short Form (SSQ6) measures functional social support	Questionnaires encounter and annually up to 3 years
Support structure measured by Medical Outcomes Study Social Support Survey (mMOS-SS)	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	Questionnaires encounter and annually up to 3 years
National survey of children's health (NSCH) for all children and youth	The NSCH, a validated survey of children's health and translated into Spanish, will assess health of children and youth	Questionnaires encounter and annually up to 3 years

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sansum Diabetes Research Institute
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: David Kerr, MBChB DM FRCP, Sansum Diabetes Research Institute

Publications and helpful links

General Publications

• Kerr D, Abbasi M, Bevier W, Glantz N, Larez A, Sabharwal A. Patterns of Timing and Intensity of Physical Activity and HbA1c Levels in Hispanic/Latino Adults With or at Risk of Type 2 Diabetes. J Diabetes Sci Technol. 2022 Jun 30:19322968221105531. doi: 10.1177/19322968221105531. Online ahead of print.
• Morales J, Glantz N, Larez A, Bevier W, Conneely M, Fan L, Reed B, Alatorre C, Paczkowski R, Ahmed T, Mackenzie A, Duncan I, Kerr D. Understanding the impact of five major determinants of health (genetics, biology, behavior, psychology, society/environment) on type 2 diabetes in U.S. Hispanic/Latino families: Mil Familias - a cohort study. BMC Endocr Disord. 2020 Jan 6;20(1):4. doi: 10.1186/s12902-019-0483-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): March 29, 2022
• Study Completion (ACTUAL): March 29, 2022

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (ACTUAL): February 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Community health worker; Latino/Hispanic; Social determinants of health; Cardio-metabolic disease; Especialista; LatinX
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2017 - 6004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) that underlie results in publications.
• IPD Sharing Time Frame: Data will be made available after the primary publication of each analysis.
• IPD Sharing Access Criteria: Data Sharing Agreements will be formulated by a committee of study investigators and community and industry partners.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No