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Peru Longitudinal Study

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ClinicalTrials.gov Identifier: NCT03742219
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
David Drozek, Ohio University

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE June 5, 2017
Estimated Primary Completion Date July 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • Weight [ Time Frame: yearly for 10 years ]
    weight in kilograms will be utilized to determine body mass index
  • Systolic blood pressure [ Time Frame: yearly for 10 years ]
    measured with a manual sphygmomanometer in millimeters of mercury
  • Diastolic Blood Pressure [ Time Frame: yearly for 10 years ]
    measured with a manual sphygmomanometer in millimeters of mercury
  • glycosylated hemoglobin [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer
  • Total cholesterol [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer
  • Low-density lipoprotein cholesterol [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer
  • High density lipoprotein cholesterol [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer
  • Triglycerides [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • Herth Hope Index [ Time Frame: yearly for 10 years ]
    validated survey utilized to evaluate level of hope for the future
  • Household hunger scale [ Time Frame: yearly for 10 years ]
    validated survey to measure food insecurity
  • Patient Health Questionnaire - 4 (PHQ-4) [ Time Frame: yearly for 10 years ]
    used to evaluate depression and anxiety
  • Exercise vital sign [ Time Frame: yearly for 10 years ]
    the minutes of exercise during the last week
  • Perceived Stress Scale [ Time Frame: yearly for 10 years ]
    validated survey to evaluate level of stress
  • 24 hour dietary recall [ Time Frame: yearly for 10 years ]
    report of all foods consumed in the last 24 hours, which will be utilized to determine the nutritional value of dietary intake
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peru Longitudinal Study
Official Title  ICMJE Longitudinal Evaluation of Disease Prevalence in Impoverished Communities of Lima, Peru
Brief Summary The purpose of this study is to evaluate the change in disease prevalence over time in impoverished urban communities in Lima, Peru.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Hypertension
  • Dyslipidemias
  • Overweight and Obesity
Intervention  ICMJE Behavioral: Lifestyle Modification
  1. Community awareness: a) individuals will be made aware of their own chronic lifestyle diseases and risk factors b) communities will be made aware of their aggregated data concerning chronic lifestyle related diseases and risk factors.
  2. Education for individuals and communities on the meaning of the lifestyle diseases and risk factors. a) individual and small group sessions explaining diseases and lifestyle measures that are helpful, b) community level education to tentatively include i) shopping guides and recipes, ii) urban gardening projects, iii) puppet shows and other community presentations, iv) literature and posters.
Study Arms  ICMJE Experimental: 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.
Intervention: Behavioral: Lifestyle Modification
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2018)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2027
Estimated Primary Completion Date July 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: David S Drozek, DO 678-447-2509 drozek@ohio.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03742219
Other Study ID Numbers  ICMJE 17-X-88
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Drozek, Ohio University
Study Sponsor  ICMJE Ohio University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David S Drozek, DO Ohio University
PRS Account Ohio University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP