NCT03830840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

3.2 years

First QC Date

January 22, 2019

Last Update Submit

June 2, 2022

Conditions

Type2 Diabetes MellitusCardiovascular Diseases

Keywords

Type 2 diabetesCardio-metabolic diseaseLatino/HispanicEspecialistaCommunity health workerSocial determinants of healthLatinX

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (57)

  • Socio-demographics assessed by questionnaire.

    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

    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

    Introductory interview/ demographics/ contacts and annually up to 3 years

  • Total daily tortilla consumption

    Introductory interview/ demographics/ contacts and annually up to 3 years

  • Daily sugary drink consumption

    Introductory interview/ demographics/ contacts and annually up to 3 years

  • +52 more secondary outcomes

Other Outcomes (1)

  • Physical activity measured by two wearable physical activity monitors for 1 week

    On-going activity encounter up to twice in 1 year

Study Arms (4)

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

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Males or females ≥ 7 years of age at enrollment.
  • Self-reported Latino heritage.
  • 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.
  • Signed and dated written informed consent by the date of enrollment.
  • 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.

You may not qualify if:

  • Life expectancy \< 6 months.
  • Any active clinically significant physical or mental disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
  • Language barriers precluding comprehension of study activities and informed consent.
  • Participation in other trials involving medication or device within 1 month prior to enrollment.
  • Known or suspected abuse of alcohol, narcotics, or illicit drugs. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (2)

  • 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.

    PMID: 35771029DERIVED

  • 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.

    PMID: 31906923DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, buffy coat (white cells), saliva, feces, urine, cheek cells

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Kerr, MBChB DM FRCP

    Sansum Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

February 5, 2019

Study Start

February 1, 2019

Primary Completion

March 29, 2022

Study Completion

March 29, 2022

Last Updated

June 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

All individual participant data (IPD) that underlie results in publications.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data will be made available after the primary publication of each analysis.
Access Criteria
Data Sharing Agreements will be formulated by a committee of study investigators and community and industry partners.
More information

Locations

US(1)