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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830840
• Other study ID #: 2017 - 6004
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: March 29, 2022

Study information

• Verified date: June 2022
• Source: Sansum Diabetes Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: March 29, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

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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. -

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
Sansum Diabetes Research Institute	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Laboratory blood draw for evaluation of lipids	Lipids will measured in a laboratory blood draw sample.	Laboratory encounter and annually up to 3 years
Secondary	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
Secondary	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
Secondary	Microalbumin measured in a urine sample	Urine sample collected for measuring microalbumin mg/L	Laboratory encounter and annually up to 3 years
Secondary	Creatinine measured in a urine sample	Urine sample collected for measuring creatinine	Laboratory encounter and annually up to 3 years
Secondary	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
Secondary	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
Secondary	Stool samples for microbiome analysis	Stool/fecal samples will be collected for microbiome analysis	Laboratory encounter and annually up to 3 years
Secondary	Height measured by Physical exam	Height measured in centimeters or inches by physical exam	Physical exam encounter and annually up to 3 years
Secondary	Weight measured by Physical exam	Weight measured in kilograms or pounds by physical exam	Physical exam encounter and annually up to 3 years
Secondary	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
Secondary	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
Secondary	Temperature measured by Physical exam	Temperature measured in degrees by physical exam	Physical exam encounter and annually up to 3 years
Secondary	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
Secondary	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
Secondary	Neuropathy Questions during Physical exam	Questions about neuropathy	Physical exam encounter and annually up to 3 years
Secondary	Retinopathy questions during Physical exam	Questions about retinopathy	Physical exam encounter and annually up to 3 years
Secondary	Dental exam Questions during Physical exam	Questions about dental exams	Physical exam encounter and annually up to 3 years
Secondary	Eye exam Questions during Physical exam	Questions about eye exams	Physical exam encounter and annually up to 3 years
Secondary	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
Secondary	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
Secondary	Determination of diabetes related foot disease	Questionnaire for determination of diabetes related foot disease (Q-DFD)	Questionnaires encounter and annually up to 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional support measured by the SSQ6	Social Support Questionnaire - Short Form (SSQ6) measures functional social support	Questionnaires encounter and annually up to 3 years
Secondary	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
Secondary	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