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Peru Longitudinal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742219
Recruitment Status : Terminated (Low level of returning participants year by year.)
First Posted : November 15, 2018
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
David Drozek, Ohio University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the change in disease prevalence over time in impoverished urban communities in Lima, Peru.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Diabetes Mellitus Hypertension Dyslipidemias Overweight and Obesity Behavioral: Lifestyle Modification Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 861 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Longitudinal Evaluation of Disease Prevalence in Impoverished Communities of Lima, Peru
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : March 1, 2020
Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: yearly for 10 years ]
    weight in kilograms will be utilized to determine body mass index

  2. Systolic blood pressure [ Time Frame: yearly for 10 years ]
    measured with a manual sphygmomanometer in millimeters of mercury

  3. Diastolic Blood Pressure [ Time Frame: yearly for 10 years ]
    measured with a manual sphygmomanometer in millimeters of mercury

  4. glycosylated hemoglobin [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer

  5. Total cholesterol [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer

  6. Low-density lipoprotein cholesterol [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer

  7. High density lipoprotein cholesterol [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer

  8. Triglycerides [ Time Frame: periodically over 10 years ]
    measured in percent via fingerstick capillary blood and portable analyzer


Secondary Outcome Measures :
  1. Herth Hope Index [ Time Frame: yearly for 10 years ]
    validated survey utilized to evaluate level of hope for the future

  2. Household hunger scale [ Time Frame: yearly for 10 years ]
    validated survey to measure food insecurity

  3. Patient Health Questionnaire - 4 (PHQ-4) [ Time Frame: yearly for 10 years ]
    used to evaluate depression and anxiety

  4. Exercise vital sign [ Time Frame: yearly for 10 years ]
    the minutes of exercise during the last week

  5. Perceived Stress Scale [ Time Frame: yearly for 10 years ]
    validated survey to evaluate level of stress

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742219


Locations
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United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
Investigators
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Principal Investigator: David S Drozek, DO Ohio University
More Information
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Responsible Party: David Drozek, Associate Professor, Ohio University
ClinicalTrials.gov Identifier: NCT03742219    
Other Study ID Numbers: 17-X-88
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Dyslipidemias
Overweight
 Body Weight
Lipid Metabolism Disorders
Metabolic Diseases