Clinical trial NCT03830840: Mil Familias Cohort Establishment: a Study to Understand Determinants of Diabetes and Its Complications Among US Latinos
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes Mellitus
Cardiovascular Diseases
Keywords: Type 2 diabetes
Cardio-metabolic disease
Latino/Hispanic
Especialista
Community health worker
Social determinants of health
LatinX
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2019-02-05
Enrollment: 405
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

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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. -

Primary outcomes:
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.
timeFrame: 3 years
Secondary outcomes:
measure: Socio-demographics assessed by questionnaire.
timeFrame: Introductory interview/ demographics/ contacts and annually up to 3 years
measure: Number of healthcare visits and the difficulty in traveling to the healthcare provider assessed by questionnaire
timeFrame: Introductory interview/ demographics/ contacts and annually up to 3 years
measure: Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions
timeFrame: Introductory interview/ demographics/ contacts and annually up to 3 years
measure: Total daily tortilla consumption
timeFrame: Introductory interview/ demographics/ contacts and annually up to 3 years
measure: Daily sugary drink consumption
timeFrame: Introductory interview/ demographics/ contacts and annually up to 3 years
measure: Number of times per week eating meals prepared away from home
timeFrame: Introductory interview/ demographics/ contacts and annually up to 3 years
measure: Laboratory blood draw for evaluation of C-Peptide related to diabetes
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of C-Reactive protein related to diabetes
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of Complete Blood Count
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of Comprehensive Metabolic Panel
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of HbA1c related to diabetes
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of Islet antigen 2 (IA-2) antibody related to diabetes
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of lipids
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of Insulin
timeFrame: Laboratory encounter and annually up to 3 years
measure: Laboratory blood draw for evaluation of thyroid function
timeFrame: Laboratory encounter and annually up to 3 years
measure: Microalbumin measured in a urine sample
timeFrame: Laboratory encounter and annually up to 3 years
measure: Creatinine measured in a urine sample
timeFrame: Laboratory encounter and annually up to 3 years
measure: Microalbumin/creatinine ratio measured in a urine sample
timeFrame: Laboratory encounter and annually up to 3 years
measure: Cheek cells and saliva for genomic analysis
timeFrame: Laboratory encounter and annually up to 3 years
measure: Stool samples for microbiome analysis
timeFrame: Laboratory encounter and annually up to 3 years
measure: Height measured by Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Weight measured by Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Waist circumference measured by Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Blood pressure measured by Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Temperature measured by Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Heart rate measured by Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Foot examination evaluated by Questions and Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Neuropathy Questions during Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Retinopathy questions during Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Dental exam Questions during Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Eye exam Questions during Physical exam
timeFrame: Physical exam encounter and annually up to 3 years
measure: Medical history, family medical history, and medication status and history assessed by interview
timeFrame: Physical exam encounter and annually up to 3 years
measure: Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview
timeFrame: Physical exam encounter and annually up to 3 years
measure: Determination of diabetes related foot disease
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)
timeFrame: Questionnaire encounter and annually up to 3 years
measure: Quality of life measured by the Short Form Health Survey (SF-12)
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Depression measured by the Patient Health Questionnaire-9
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Adverse Childhood Experiences (ACE) quantified by ACE questionnaire
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Spirituality measured by a Spiritual Well Being Scale
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Risk Perception Survey For Developing Diabetes (RPS-DD)
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Stress measured by the 4 item Perceived Stress Scale (PSS)
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Diabetes management measured by the Diabetes Symptom Self-Care Inventory
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Family diabetes management measured by questionnaire
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Foot self care confidence measured by questionnaire
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Health literacy measured by the Short Assessment of Health Literacy (SAHL)
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Measurement of health numeracy
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Trust in physician measured by the Trust in Physician (TPS) questionnaire
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Social needs screening assessed by the Health Leads Screening toolkit
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Food security assessed by U.S. Household Food Security Survey Module: Six-item short form
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Functional support measured by the SSQ6
timeFrame: Questionnaires encounter and annually up to 3 years
measure: Support structure measured by Medical Outcomes Study Social Support Survey (mMOS-SS)
timeFrame: Questionnaires encounter and annually up to 3 years
measure: National survey of children's health (NSCH) for all children and youth
timeFrame: Questionnaires encounter and annually up to 3 years
Other outcomes:
measure: Physical activity measured by two wearable physical activity monitors for 1 week
timeFrame: On-going activity encounter up to twice in 1 year
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Sansum Diabetes Research Institute
name: David Kerr, MBChB DM FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2024 Jan;18(1):106-112. doi: 10.1177/19322968221105531. Epub 2022 Jun 30.
citation: 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.