Peru Longitudinal Study

Longitudinal Evaluation of Disease Prevalence in Impoverished Communities of Lima, Peru

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

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases; Hypertension; Diabetes Mellitus; Dyslipidemias; Overweight and Obesity
• Intervention / Treatment: Behavioral: Lifestyle Modification

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: Interventional
• Enrollment (Actual): 861
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	weight in kilograms will be utilized to determine body mass index	yearly for 10 years
Systolic blood pressure	measured with a manual sphygmomanometer in millimeters of mercury	yearly for 10 years
Diastolic Blood Pressure	measured with a manual sphygmomanometer in millimeters of mercury	yearly for 10 years
glycosylated hemoglobin	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
Total cholesterol	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
Low-density lipoprotein cholesterol	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
High density lipoprotein cholesterol	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
Triglycerides	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Herth Hope Index	validated survey utilized to evaluate level of hope for the future	yearly for 10 years
Household hunger scale	validated survey to measure food insecurity	yearly for 10 years
Patient Health Questionnaire - 4 (PHQ-4)	used to evaluate depression and anxiety	yearly for 10 years
Exercise vital sign	the minutes of exercise during the last week	yearly for 10 years
Perceived Stress Scale	validated survey to evaluate level of stress	yearly for 10 years
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	yearly for 10 years

Collaborators and Investigators

• Sponsor: Ohio University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Body Weight; Lipid Metabolism Disorders; Cardiovascular Diseases; Dyslipidemias; Overweight
• Other Study ID Numbers: 17-X-88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No