Mil Familias-Santa Barbara's Operational Pilot to Understand Diabetes in the Latino Community

NCT03736486 | Completed

• 1 other identifier: 2017-5864
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The Mil Familias Program is a 10-year initiative to reduce the burden of cardio-metabolic disease among Latino families in the Central Coast of California. The Mil Familias Program involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, measuring the 5 determinants of human health: genetics, biology, behavior, psychology and environment, training Latino community health workers ("Especialistas") , creating a Living Information (bio)Bank and planning culturally-relevant interventions.

Conditions

Type2 Diabetes Mellitus; Cardiovascular Diseases

Keywords

Type 2 diabetes; Cardio-metabolic disease; Latino; Hispanic; Especialista

Outcome Measures

Primary Outcomes (1)

• Success (evaluated by Yes/No format) recruiting and establishing a pilot cohort of 100 Latino adults with Type 2 Diabetes and creating data collection methods to describe genetics, biology, behavior, psychology, & environment in Type 2 Diabetes

  Mil Familias Program Pilot will measure genetic influences by a family medical history \& biobank blood samples. Biologic influences will include laboratory blood draw, physical exam with vital signs \& waist circumference measurement, and complete medical \& medication history with female menopause, pregnancy, \& gestational diabetes status. Behavior influences will include sleep, stress, drug abuse, and diabetes self-assessment management questionnaires. Wearable devices will measure physical activity. Psychological influences will include Patient Health Questionnaire-9, Brief Perceived Ethnic Discrimination Questionnaire Community Version, and Short Form Health Survey. Social/environmental influences will include socio-demographics, Brief Acculturation Scale for Hispanics, personal opinions about type 2 diabetes, and questionnaires \[Short Assessment of Health Literacy, Trust in Physician, Health Leads Screening Toolkit, and U.S. Household Food Security Survey\].

  1 year

Secondary Outcomes (22)

• Socio-demographics measured by questionnaire - including age, gender, race/ethnicity, contact information, number in household, income, education, marital status, occupation, insurance status, immigration status, alcohol & tobacco use, and birth place

  Beginning of study - Baseline visit 1

• Self-assessment of diabetes management measured by the American Diabetes Association questionnaire, Participant Self-Assessment of Diabetes Management

  Beginning of study - Baseline visit 1

• Food security assessed by U.S. Household Food Security Survey Module: Six-item short form

  Beginning of study - Baseline visit 1

• Social needs screening assessed by the Health Leads Screening Toolkit

  Beginning of study - Baseline visit 1

• Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by electronic medical record and interview

  Beginning of study - Baseline visit 1

Other Outcomes (2)

• Engagement of a local consortium of partners to implement participant recruitment; data collection, storage, and analysis; healthcare access; and/or intervention measured by the number of major operational partnerships with formal agreements

  1 year

• Success measured by the number of health care workers trained, upskilled, and employed to be community health care workers (Especialistas) and the number of participant encounters with a trained health care worker

  1 year

Study Arms (1)

Type 2 Diabetes

Male and female adults of Hispanic and/or Latino heritage with an established diagnosis of Type 2 diabetes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 125 individuals may be screened and enrolled with the prediction of 20% screen-fail or dropout and 100 people completing SB1K Phase I.

You may qualify if:

• Males or females ≥ 18 years of age at Visit 1 (screening and enrollment).
• Self-reported Hispanic and/or Latino heritage.
• Currently residing in Santa Barbara County, California.
• 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 Visit 1.
• Based on the research staff's judgment, subject 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:

• Diagnosed severe cardiovascular disease, within the 6 months prior to enrollment Visit 1, defined as: previous stroke; decompensated heart failure New York Heart Association class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty.
• Life expectancy \< 2 years.
• Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
• Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent.
• Participation in other trials involving medication or device within 1 month prior to Visit 1.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (2)

• Glantz NM, Morales JM, Bevier WC, Larez A, Hoppe CB, Duncan I, Mackenzie A, Kerr D. Insurance Status and Biological and Psychosocial Determinants of Cardiometabolic Risk Among Mexican-Origin U.S. Hispanic/Latino Adults with Type 2 Diabetes. Health Equity. 2020 May 4;4(1):142-149. doi: 10.1089/heq.2019.0119. eCollection 2020.

  PMID: 32440613 DERIVED

• Bevier W, Glantz N, Hoppe C, Morales Glass J, Larez A, Chen K, Kerr D. Self-reported and objectively measured physical activity levels among Hispanic/Latino adults with type 2 diabetes. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e000893. doi: 10.1136/bmjdrc-2019-000893.

  PMID: 32169933 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Buffy coat (white cells)

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Kerr, M.D.

  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: October 30, 2018
• First Posted: November 9, 2018
• Study Start: August 24, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)