- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03742219
Peru Longitudinal Study
Longitudinal Evaluation of Disease Prevalence in Impoverished Communities of Lima, Peru
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
The aim is to track the changes in disease prevalence of people living in impoverished urban communities in Lima over the next 10 years.
Based on data collected in prior years and in an ongoing manner, Ohio University Global Health teams will be introducing interventions focused to positively impact disease states and trends in this population.
The current focus is on chronic lifestyle related diseases and their precursors: cardiovascular disease, hypertension, dyslipidemia, diabetes, and overweight / obesity.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ohio
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Athens, Ohio, Forenede Stater, 45701
- Ohio University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- minors age 12-17 presenting to the free community clinic, with a responsible adult who can give consent; minors will give assent.
- consenting adults of any age who present to the clinic.
Exclusion Criteria:
- adults who are unable to give consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Lifestyle Intervention
Impoverished communities in Lima, Peru will be offered free medical clinics.
Four communities have been chosen initially for focus over the following 10 years.
These communities will be made aware of their risk for chronic lifestyle related diseases.
In conjunction with the communities, specific interventions focused on a plant-based diet, physical activity, stress management and control of unhealthy habits will be devised.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Weight
Tidsramme: yearly for 10 years
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weight in kilograms will be utilized to determine body mass index
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yearly for 10 years
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Systolic blood pressure
Tidsramme: yearly for 10 years
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measured with a manual sphygmomanometer in millimeters of mercury
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yearly for 10 years
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Diastolic Blood Pressure
Tidsramme: yearly for 10 years
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measured with a manual sphygmomanometer in millimeters of mercury
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yearly for 10 years
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glycosylated hemoglobin
Tidsramme: periodically over 10 years
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measured in percent via fingerstick capillary blood and portable analyzer
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periodically over 10 years
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Total cholesterol
Tidsramme: periodically over 10 years
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measured in percent via fingerstick capillary blood and portable analyzer
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periodically over 10 years
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Low-density lipoprotein cholesterol
Tidsramme: periodically over 10 years
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measured in percent via fingerstick capillary blood and portable analyzer
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periodically over 10 years
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High density lipoprotein cholesterol
Tidsramme: periodically over 10 years
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measured in percent via fingerstick capillary blood and portable analyzer
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periodically over 10 years
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Triglycerides
Tidsramme: periodically over 10 years
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measured in percent via fingerstick capillary blood and portable analyzer
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periodically over 10 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Herth Hope Index
Tidsramme: yearly for 10 years
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validated survey utilized to evaluate level of hope for the future
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yearly for 10 years
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Household hunger scale
Tidsramme: yearly for 10 years
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validated survey to measure food insecurity
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yearly for 10 years
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Patient Health Questionnaire - 4 (PHQ-4)
Tidsramme: yearly for 10 years
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used to evaluate depression and anxiety
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yearly for 10 years
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Exercise vital sign
Tidsramme: yearly for 10 years
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the minutes of exercise during the last week
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yearly for 10 years
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Perceived Stress Scale
Tidsramme: yearly for 10 years
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validated survey to evaluate level of stress
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yearly for 10 years
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24 hour dietary recall
Tidsramme: yearly for 10 years
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report of all foods consumed in the last 24 hours, which will be utilized to determine the nutritional value of dietary intake
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yearly for 10 years
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17-X-88
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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