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

NCT ID: NCT03830840

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 405 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-03-29

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.

Conditions

Type2 Diabetes Mellitus; Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adult Individuals with Type 2 diabetes

Individuals ≥18 years of Hispanic/Latino heritage with an established diagnosis of type 2 diabetes

No interventions assigned to this group

Adult Family member

Adult family members, ≥18 years, of the individual with type 2 diabetes

No interventions assigned to this group

Child family member with diabetes

Child, ≥7 years but \<18 years, family member with diabetes

No interventions assigned to this group

Child family member without diabetes

Child, ≥7 years but \<18 years, family member without diabetes

No interventions assigned to this group

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. -

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kerr, MBChB DM FRCP

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35771029 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31906923 (View on PubMed)

Other Identifiers

2017 - 6004

Identifier Type: -

Identifier Source: org_study_id