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Peru Longitudinal Study

Primary Purpose

Cardiovascular Diseases, Diabetes Mellitus, Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Modification
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ohio University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Weight
weight in kilograms will be utilized to determine body mass index
Systolic blood pressure
measured with a manual sphygmomanometer in millimeters of mercury
Diastolic Blood Pressure
measured with a manual sphygmomanometer in millimeters of mercury
glycosylated hemoglobin
measured in percent via fingerstick capillary blood and portable analyzer
Total cholesterol
measured in percent via fingerstick capillary blood and portable analyzer
Low-density lipoprotein cholesterol
measured in percent via fingerstick capillary blood and portable analyzer
High density lipoprotein cholesterol
measured in percent via fingerstick capillary blood and portable analyzer
Triglycerides
measured in percent via fingerstick capillary blood and portable analyzer

Secondary Outcome Measures

Herth Hope Index
validated survey utilized to evaluate level of hope for the future
Household hunger scale
validated survey to measure food insecurity
Patient Health Questionnaire - 4 (PHQ-4)
used to evaluate depression and anxiety
Exercise vital sign
the minutes of exercise during the last week
Perceived Stress Scale
validated survey to evaluate level of stress
24 hour dietary recall
report of all foods consumed in the last 24 hours, which will be utilized to determine the nutritional value of dietary intake

Full Information

First Posted
November 12, 2018
Last Updated
March 10, 2021
Sponsor
Ohio University
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1. Study Identification

Unique Protocol Identification Number
NCT03742219
Brief Title
Peru Longitudinal Study
Official Title
Longitudinal Evaluation of Disease Prevalence in Impoverished Communities of Lima, Peru
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Low level of returning participants year by year.
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Dyslipidemias, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
861 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Lifestyle Modification
Intervention Description
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. 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.
Primary Outcome Measure Information:
Title
Weight
Description
weight in kilograms will be utilized to determine body mass index
Time Frame
yearly for 10 years
Title
Systolic blood pressure
Description
measured with a manual sphygmomanometer in millimeters of mercury
Time Frame
yearly for 10 years
Title
Diastolic Blood Pressure
Description
measured with a manual sphygmomanometer in millimeters of mercury
Time Frame
yearly for 10 years
Title
glycosylated hemoglobin
Description
measured in percent via fingerstick capillary blood and portable analyzer
Time Frame
periodically over 10 years
Title
Total cholesterol
Description
measured in percent via fingerstick capillary blood and portable analyzer
Time Frame
periodically over 10 years
Title
Low-density lipoprotein cholesterol
Description
measured in percent via fingerstick capillary blood and portable analyzer
Time Frame
periodically over 10 years
Title
High density lipoprotein cholesterol
Description
measured in percent via fingerstick capillary blood and portable analyzer
Time Frame
periodically over 10 years
Title
Triglycerides
Description
measured in percent via fingerstick capillary blood and portable analyzer
Time Frame
periodically over 10 years
Secondary Outcome Measure Information:
Title
Herth Hope Index
Description
validated survey utilized to evaluate level of hope for the future
Time Frame
yearly for 10 years
Title
Household hunger scale
Description
validated survey to measure food insecurity
Time Frame
yearly for 10 years
Title
Patient Health Questionnaire - 4 (PHQ-4)
Description
used to evaluate depression and anxiety
Time Frame
yearly for 10 years
Title
Exercise vital sign
Description
the minutes of exercise during the last week
Time Frame
yearly for 10 years
Title
Perceived Stress Scale
Description
validated survey to evaluate level of stress
Time Frame
yearly for 10 years
Title
24 hour dietary recall
Description
report of all foods consumed in the last 24 hours, which will be utilized to determine the nutritional value of dietary intake
Time Frame
yearly for 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Drozek, DO
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Peru Longitudinal Study

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