Type2 Diabetes MellitusMilFamiliasNCT03736486
Mil Familias-Santa Barbara's Operational Pilot to Understand Diabetes in the Latino Community
An observational study of Type2 Diabetes Mellitus and Cardiovascular Diseases, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Mil Familias- Santa Barbara Operational Pilot
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.
Read the detailed description
The Mil Familias Pilot Study aims to develop, operationalize and refine methods to both recruit and collect data from 100 adult participants pertaining to the 5 determinants of human health: genetics, biology, behavior, psychology and environment. Specially-trained Latino and bilingual community health workers known as "Especialistas" will be used to help gather data and to serve as the participants trustworthy health companion. Over 100 variables of information pertaining to the 5 determinants of human health (as listed above) will be gathered and stored to create a Living Information (bio)Bank particular to Latinos. The ultimate goal of this research is to provide the target population with effective, culturally-relevant interventions that are geared toward population specific needs.
- Conditions
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Type 2 diabetes, Cardio-metabolic disease, Latino, Hispanic, Especialista
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Male and female adults of Hispanic and/or Latino heritage with an established diagnosis of Type 2 diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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
Socio-demographics assessed by questionnaire.
Measured: Beginning of study - Baseline visit 1
Self-assessment of diabetes management measured by the American Diabetes Association questionnaire, Participant Self-Assessment of Diabetes Management
Participant report and self-assessment of diabetes management by questionnaire
Measured: Beginning of study - Baseline visit 1
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
Measured: Beginning of study - Baseline visit 1
Social needs screening assessed by the Health Leads Screening Toolkit
The Health Leads Screening Tookit (Boston, MA) will be used to determine social needs
Measured: 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
Number of healthcare visits assessed in medical record review and the difficulty in traveling to the healthcare provider assessed by questionnaire
Measured: Beginning of study - Baseline visit 1
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?
Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions
Measured: Beginning of study - Baseline visit 1
Support for diabetes care measured by questionnaire adapted from the American Diabetes Association Participant Self-Assessment of Diabetes Management questionnaire
How well a participant is supported in diabetes care measured by a questionnaire from the American Diabetes Association (ADA) Participant Self-Assessment of Diabetes Management questionnaire
Measured: Beginning of study - Baseline visit 1
Medical history, family medical history, and medication status and history assessed by interview and electronic medical records
Medical history, family medical history, and current medications and medication history assessed by interview and electronic medical records
Measured: Day 1 of Visit 2
Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview and electronic medical records
Menopausal status, pregnancy status, and gestational diabetes history for female participants will be determined by interview and electronic medical records
Measured: Day 1 of Visit 2
Measurement by composite physical exam - height, weight, waist circumference, blood pressure, temperature, heart rate & rhythm, and foot examination including questions about neuropathy and retinopathy and dental & eye exams
Physical exam with vital signs and questions about neuropathy, retinopathy, dental, and eye exams
Measured: Day 1 of Visit 2
Composite lab tests: C-Peptide, C-reactive protein, Complete blood count, Comprehensive metabolic panel, Glutamic Acid Decarboxylase (GAD) antibodies, HbA1c, Insulin autoantibody, Lipid panel, Insulin, and Thyroid function
Laboratory blood draw for evaluation of physiological markers related to diabetes
Measured: Day 1 of Visit 2
Microalbumin, creatinine, and microalbumin/creatinine ratio measured in a urine sample
Urine sample collected for measuring microalbumin, creatinine, and the microalbumin/creatinine ratio
Measured: Day 1 of Visit 2
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
Measured: Day 1 of Visit 2
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
Measured: Day 1 of Visit 2
Physical activity measured by two wearable physical activity monitors for 1 week
Participants wear an ActiGraph and Fitbit activity monitors simultaneously for 1 week
Measured: 1 week
Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)
BASH is a participant reported questionnaire to measure acculturation
Measured: Day 1 of Visit 3
Health literacy measured by the Short Assessment of Health Literacy (SAHL)
SAHL is a participant reported questionnaire to measure health literacy
Measured: Day 1 of Visit 3
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
Measured: Day 1 of Visit 3
Stress measured by the 4 item Perceived Stress Scale (PSS)
PSS is a participant reported questionnaire to measure stress
Measured: Day 1 of Visit 3
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
Measured: Day 1 of Visit 3
Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)
The OSQ is a participant reported questionnaire to measure sleep quality
Measured: Day 1 of Visit 3
Trust in physician measured by the Trust in Physician (TPS) questionnaire
The TPS is a questionnaire and scale to determine trust in the physician
Measured: Day 1 of Visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start24 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- David Kerr, M.D., Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736486
- Sponsor's protocol ID
- 2017-5864
- Acronym
- MilFamilias
- Status last verified
- Jan 2019
- First submitted
- 30 Oct 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in publications.
Publications
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.
PubMed 32440613Bevier 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.
PubMed 32169933
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mil Familias- Santa Barbara Operational Pilot
- ClinicalTrials.gov ID
- NCT03736486
- Acronym / sponsor ID
- MilFamilias / 2017-5864
- Conditions
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Type 2 diabetes, Cardio-metabolic disease, Latino, Hispanic, Especialista
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Mil Familias Pilot Study aims to develop, operationalize and refine methods to both recruit and collect data from 100 adult participants pertaining to the 5 determinants of human health: genetics, biology, behavior, psychology and environment. Specially-trained Latino and bilingual community health workers known as "Especialistas" will be used to help gather data and to serve as the participants trustworthy health companion. Over 100 variables of information pertaining to the 5 determinants of human health (as listed above) will be gathered and stored to create a Living Information (bio)Bank particular to Latinos. The ultimate goal of this research is to provide the target population with effective, culturally-relevant interventions that are geared toward population specific needs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | –Male and female adults of Hispanic and/or Latino heritage with an established diagnosis of Type 2 diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 1 year
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].
22 secondary outcomes
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
Time frame: Beginning of study - Baseline visit 1
Self-assessment of diabetes management measured by the American Diabetes Association questionnaire, Participant Self-Assessment of Diabetes Management
Time frame: Beginning of study - Baseline visit 1
Food security assessed by U.S. Household Food Security Survey Module: Six-item short form
Time frame: Beginning of study - Baseline visit 1
Social needs screening assessed by the Health Leads Screening Toolkit
Time frame: 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
Time frame: Beginning of study - Baseline visit 1
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?
Time frame: Beginning of study - Baseline visit 1
Support for diabetes care measured by questionnaire adapted from the American Diabetes Association Participant Self-Assessment of Diabetes Management questionnaire
Time frame: Beginning of study - Baseline visit 1
Medical history, family medical history, and medication status and history assessed by interview and electronic medical records
Time frame: Day 1 of Visit 2
Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview and electronic medical records
Time frame: Day 1 of Visit 2
Measurement by composite physical exam - height, weight, waist circumference, blood pressure, temperature, heart rate & rhythm, and foot examination including questions about neuropathy and retinopathy and dental & eye exams
Time frame: Day 1 of Visit 2
Composite lab tests: C-Peptide, C-reactive protein, Complete blood count, Comprehensive metabolic panel, Glutamic Acid Decarboxylase (GAD) antibodies, HbA1c, Insulin autoantibody, Lipid panel, Insulin, and Thyroid function
Time frame: Day 1 of Visit 2
Microalbumin, creatinine, and microalbumin/creatinine ratio measured in a urine sample
Time frame: Day 1 of Visit 2
Depression measured by the Patient Health Questionnaire-9
Time frame: Day 1 of Visit 2
Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20
Time frame: Day 1 of Visit 2
Physical activity measured by two wearable physical activity monitors for 1 week
Time frame: 1 week
Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)
Time frame: Day 1 of Visit 3
Health literacy measured by the Short Assessment of Health Literacy (SAHL)
Time frame: Day 1 of Visit 3
Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)
Time frame: Day 1 of Visit 3
Stress measured by the 4 item Perceived Stress Scale (PSS)
Time frame: Day 1 of Visit 3
Quality of life measured by the Short Form Health Survey (SF-12)
Time frame: Day 1 of Visit 3
Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)
Time frame: Day 1 of Visit 3
Trust in physician measured by the Trust in Physician (TPS) questionnaire
Time frame: Day 1 of Visit 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Derived from this study: PubMed 32440613Glantz 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.
- Derived from this study: PubMed 32169933Bevier 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.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kerr, M.D. principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes Mellitus and Cardiovascular Diseases, run by Sansum Diabetes Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736486, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.