Health and Cardiovascular Risk Factors in Slums.

July 28, 2021 updated by: Fundacion GESICA

Health and Cardiovascular Risk Factors Survey in the 31's Slum.

Cardiovascular risk factors and disease burden has been showed to affect more deeply to poorer populations. People who live in slums are the most vulnerable subgroup in the populations where, paradoxically scarcity of data exists on risk factors and cardiovascular disease burden.

Our study aim to describe the prevalence of cardiovascular risk factors and cardiovascular disease burden in a representative sample of an urban slum of Buenos Aires city, using validated questions from the National Risk Factors Survey (edition 2013). Also, the investigators will measure blood pressure and cardiac rate to all study participants.

Study Overview

Status

Active, not recruiting

Detailed Description

Cardiovascular risk factors and disease burden has been showed to affect more deeply to poorer populations. People who live in slums are the most vulnerable subgroup in the populations where, paradoxically scarcity of data exists on risk factors and cardiovascular disease burden.

Hypothesis: the prevalence of modifiable cardiovascular risk factors in an urban slum from Buenos Aires city is higher than the rest of the country and, consequently requires a distinctive management approach.

Objectives:

  1. To measure the prevalence of cardiovascular risk factors in a representative sample of the villa 31 (an urban slum from Buenos Aires city).
  2. To measure the self-perceived health in a representative sample of the villa 31 (urban slum from Buenos Aires city).

Design: observational study. Survey. Procedures: the survey will be conducted by neighbors from the slum that received specific training as community health workers and were trained on the use of the survey questionnaire and for blood pressure measuring.

Sampling: representative samples of slum population will be obtained using probabilistic, multi-staged sampling methods.

Blood pressure measures: blood pressure will be measured using automatic blood pressure monitoring device with appropriate cuff sizes.

Statistical analyses: categorical variables will be expressed as numbers and percentages, and continuous variable as means and standard deviations or medians and interquartile ranges. Between groups comparisons will be conducted using chi2 test for categorical variables and T test or Mann-Whitney U's test for continuous variables. To compare the prevalence of risk factors with the rest of the country, the database will be jointed with the national risk factor survey (publicly available). All analyses will be weighted to account for the sampling method.

Study Type

Observational

Enrollment (Anticipated)

2265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Buenos Aires
      • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, C1034ACD
        • Fundación GESICA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adults of the slum that accept to participate in the survey.

Description

Inclusion Criteria: >= 18 years. Sign the informed consent.

-

Exclusion Criteria: Unable to answer the survey. Unwilling to participate.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension
Time Frame: Through study completion, an average of 3 months
Blood pressure >=140/90 mmHg or being taking antihypertensive medication.
Through study completion, an average of 3 months
Smoking
Time Frame: Through study completion, an average of 3 months
Percentage of participants that self-report current smoking
Through study completion, an average of 3 months
Hypercholesterolemia
Time Frame: Through study completion, an average of 3 months
Self-reported plasma high cholesterol levels.
Through study completion, an average of 3 months
Diabetes
Time Frame: Through study completion, an average of 3 months
Percentage of participants that self-report as had been diagnosed as diabetic or receiving medical therapy for diabetes.
Through study completion, an average of 3 months
Self-perceived health
Time Frame: Through study completion, an average of 3 months
Percentage of participants that report their health status as self-perceived in a 5-points Likert' scale from "Excellent" to "Bad"
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Previous myocardial infarction
Time Frame: through study completion, an average of 3 months
Self-reported history of myocardial infarction.
through study completion, an average of 3 months
Previous stroke
Time Frame: through study completion, an average of 3 months
Self-reported history of stroke.
through study completion, an average of 3 months
Physical activity
Time Frame: Through study completion, an average of 3 months
Percentage of participants with self-reported physical activity levels in a Likert' scale (from "Less than 10 min/week" to "Equal or more than 150 min/week").
Through study completion, an average of 3 months
Healthy diet
Time Frame: through study completion, an average of 3 months
Self-reported consumption of vegetables and fruits.
through study completion, an average of 3 months
Body mass index
Time Frame: through study completion, an average of 3 months
Body weight divided by the height squared in meters (both body weight and height as self-reported.
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Javier Mariani, MD, Fundación GESICA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0004

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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