Health and Cardiovascular Risk Factors in Slums.

Sponsor
Fundacion GESICA (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03734939
Collaborator
Escuela de Psicología Social Pichon Riviere (Other), Corriente Salvador Maza (Other)
2,265
1
49.4
45.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: None intervention is planned.

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 Design

Study Type:
Observational
Anticipated Enrollment :
2265 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Health and Cardiovascular Risk Factors Survey in the 31's Slum.
Actual Study Start Date :
Nov 7, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Outcome Measures

Primary Outcome Measures

  1. Hypertension [Through study completion, an average of 3 months]

    Blood pressure >=140/90 mmHg or being taking antihypertensive medication.

  2. Smoking [Through study completion, an average of 3 months]

    Percentage of participants that self-report current smoking

  3. Hypercholesterolemia [Through study completion, an average of 3 months]

    Self-reported plasma high cholesterol levels.

  4. Diabetes [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.

  5. Self-perceived health [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"

Secondary Outcome Measures

  1. Previous myocardial infarction [through study completion, an average of 3 months]

    Self-reported history of myocardial infarction.

  2. Previous stroke [through study completion, an average of 3 months]

    Self-reported history of stroke.

  3. Physical activity [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").

  4. Healthy diet [through study completion, an average of 3 months]

    Self-reported consumption of vegetables and fruits.

  5. Body mass index [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

-

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fundación GESICA Ciudad Autónoma de Buenos Aire Buenos Aires Argentina C1034ACD

Sponsors and Collaborators

  • Fundacion GESICA
  • Escuela de Psicología Social Pichon Riviere
  • Corriente Salvador Maza

Investigators

  • Principal Investigator: Javier Mariani, MD, Fundación GESICA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundacion GESICA
ClinicalTrials.gov Identifier:
NCT03734939
Other Study ID Numbers:
  • 0004
First Posted:
Nov 8, 2018
Last Update Posted:
Jul 30, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundacion GESICA
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 30, 2021