Peru Longitudinal Study

Not Applicable

Terminated

• Conditions: Cardiovascular Diseases; Diabetes Mellitus; Hypertension; Dyslipidemias; Overweight and Obesity
• Interventions: Behavioral: Lifestyle Modification

• Registration Number: NCT03742219
• Lead Sponsor: Ohio University

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 Timeline

• Study Start: 2017-06-05
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-15
• Primary Completion: 2019-10-01
• Study Completion: 2020-03-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 861

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Lifestyle Modification	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ohio University; 🇺🇸 Athens, Ohio, United States