NCT03830840已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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").
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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. -
结局指标
主要结局
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.
时间窗: 3 years
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.
次要结局
- Height measured by Physical exam(Physical exam encounter and annually up to 3 years)
- Waist circumference measured by Physical exam(Physical exam encounter 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)
- Laboratory blood draw for evaluation of thyroid function(Laboratory encounter and annually up to 3 years)
- Socio-demographics assessed by questionnaire.(Introductory interview/ demographics/ contacts and annually up to 3 years)
- Laboratory blood draw for evaluation of Complete Blood Count(Laboratory encounter and annually up to 3 years)
- Laboratory blood draw for evaluation of Comprehensive Metabolic Panel(Laboratory encounter and annually up to 3 years)
- Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes(Laboratory encounter 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)
- Daily sugary drink consumption(Introductory interview/ demographics/ contacts and annually up to 3 years)
- Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes(Laboratory encounter and annually up to 3 years)
- Laboratory blood draw for evaluation of Insulin(Laboratory encounter and annually up to 3 years)
- Microalbumin measured in a urine sample(Laboratory encounter and annually up to 3 years)
- Total daily tortilla consumption(Introductory interview/ demographics/ contacts and annually up to 3 years)
- Number of times per week eating meals prepared away from home(Introductory interview/ demographics/ contacts and annually up to 3 years)
- Laboratory blood draw for evaluation of C-Peptide related to diabetes(Laboratory encounter and annually up to 3 years)
- Laboratory blood draw for evaluation of C-Reactive protein related to diabetes(Laboratory encounter and annually up to 3 years)
- Creatinine measured in a urine sample(Laboratory encounter and annually up to 3 years)
- Stool samples for microbiome analysis(Laboratory encounter and annually up to 3 years)
- Temperature measured by Physical exam(Physical exam encounter and annually up to 3 years)
- Medical history, family medical history, and medication status and history assessed by interview(Physical exam encounter and annually up to 3 years)
- Diabetes management measured by the Diabetes Symptom Self-Care Inventory(Questionnaires encounter and annually up to 3 years)
- Health literacy measured by the Short Assessment of Health Literacy (SAHL)(Questionnaires encounter and annually up to 3 years)
- Laboratory blood draw for evaluation of HbA1c related to diabetes(Laboratory encounter and annually up to 3 years)
- Laboratory blood draw for evaluation of lipids(Laboratory encounter and annually up to 3 years)
- Weight measured by Physical exam(Physical exam encounter and annually up to 3 years)
- Heart rate measured by Physical exam(Physical exam encounter and annually up to 3 years)
- Determination of diabetes related foot disease(Questionnaires encounter and annually up to 3 years)
- Risk Perception Survey For Developing Diabetes (RPS-DD)(Questionnaires encounter and annually up to 3 years)
- Foot self care confidence measured by questionnaire(Questionnaires encounter and annually up to 3 years)
- Trust in physician measured by the Trust in Physician (TPS) questionnaire(Questionnaires encounter and annually up to 3 years)
- Social needs screening assessed by the Health Leads Screening toolkit(Questionnaires encounter and annually up to 3 years)
- Laboratory blood draw for evaluation of Islet antigen 2 (IA-2) antibody related to diabetes(Laboratory encounter and annually up to 3 years)
- Microalbumin/creatinine ratio measured in a urine sample(Laboratory encounter and annually up to 3 years)
- Foot examination evaluated by Questions and Physical exam(Physical exam encounter and annually up to 3 years)
- Neuropathy Questions during Physical exam(Physical exam encounter and annually up to 3 years)
- Retinopathy questions during Physical exam(Physical exam encounter and annually up to 3 years)
- Quality of life measured by the Short Form Health Survey (SF-12)(Questionnaires encounter and annually up to 3 years)
- Adverse Childhood Experiences (ACE) quantified by ACE questionnaire(Questionnaires encounter and annually up to 3 years)
- Spirituality measured by a Spiritual Well Being Scale(Questionnaires encounter and annually up to 3 years)
- Stress measured by the 4 item Perceived Stress Scale (PSS)(Questionnaires encounter and annually up to 3 years)
- Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20(Questionnaires encounter and annually up to 3 years)
- Food security assessed by U.S. Household Food Security Survey Module: Six-item short form(Questionnaires encounter and annually up to 3 years)
- Cheek cells and saliva for genomic analysis(Laboratory encounter and annually up to 3 years)
- Blood pressure measured by Physical exam(Physical exam encounter and annually up to 3 years)
- Dental exam Questions during Physical exam(Physical exam encounter and annually up to 3 years)
- Eye exam Questions during Physical exam(Physical exam encounter and annually up to 3 years)
- Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview(Physical exam encounter and annually up to 3 years)
- Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)(Questionnaire encounter and annually up to 3 years)
- Depression measured by the Patient Health Questionnaire-9(Questionnaires encounter and annually up to 3 years)
- Family diabetes management measured by questionnaire(Questionnaires encounter and annually up to 3 years)
- Measurement of health numeracy(Questionnaires encounter and annually up to 3 years)
- National survey of children's health (NSCH) for all children and youth(Questionnaires encounter and annually up to 3 years)
- Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)(Questionnaires encounter and annually up to 3 years)
- Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)(Questionnaires encounter and annually up to 3 years)
- Functional support measured by the SSQ6(Questionnaires encounter and annually up to 3 years)
- Support structure measured by Medical Outcomes Study Social Support Survey (mMOS-SS)(Questionnaires encounter and annually up to 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Cohort of Patients with Alzheimer's Disease and Their Families.Alzheimer DiseaseNCT05516667University Hospital, Toulouse1,000
已完成
不适用
Mil Familias-Santa Barbara's Operational Pilot to Understand Diabetes in the Latino CommunityType2 Diabetes MellitusCardiovascular DiseasesNCT03736486Sansum Diabetes Research Institute100
已完成
不适用
Community Active and Healthy FamiliesObesity, ChildhoodNCT04414553University of Colorado, Denver78
进行中（未招募）
不适用
Innovative Family Prevention With Latino Siblings in Disadvantaged SettingsPromotion of Positive Sibling RelationshipsNCT03706014Harvard University270
已完成
不适用
Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization TrialAdolescent - Emotional ProblemParent-Child RelationsFamily FunctioningWell-Being, PsychologicalNCT06562244University of Klagenfurt1,316