Peru Longitudinal Study

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03742219
• Other study ID #: 17-X-88
• Status: Terminated
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2021
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 861
• Est. completion date: March 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Dyslipidemias
• Hypertension
• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	weight in kilograms will be utilized to determine body mass index	yearly for 10 years
Primary	Systolic blood pressure	measured with a manual sphygmomanometer in millimeters of mercury	yearly for 10 years
Primary	Diastolic Blood Pressure	measured with a manual sphygmomanometer in millimeters of mercury	yearly for 10 years
Primary	glycosylated hemoglobin	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
Primary	Total cholesterol	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
Primary	Low-density lipoprotein cholesterol	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
Primary	High density lipoprotein cholesterol	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
Primary	Triglycerides	measured in percent via fingerstick capillary blood and portable analyzer	periodically over 10 years
Secondary	Herth Hope Index	validated survey utilized to evaluate level of hope for the future	yearly for 10 years
Secondary	Household hunger scale	validated survey to measure food insecurity	yearly for 10 years
Secondary	Patient Health Questionnaire - 4 (PHQ-4)	used to evaluate depression and anxiety	yearly for 10 years
Secondary	Exercise vital sign	the minutes of exercise during the last week	yearly for 10 years
Secondary	Perceived Stress Scale	validated survey to evaluate level of stress	yearly for 10 years
Secondary	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