Health and Cardiovascular Risk Factors in Slums.

• ClinicalTrials.gov Identifier: NCT03734939
• Recruitment Status: Active, not recruiting
• First Posted: November 8, 2018
• Last Update Posted: July 30, 2021
• Sponsor: Fundacion GESICA
• Collaborators: Escuela de Psicología Social Pichon Riviere; Corriente Salvador Maza
• Information provided by (Responsible Party): Fundacion GESICA

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
Cardiovascular Risk Factor; Cardiovascular Diseases	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
• Estimated 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: November 7, 2018
• Estimated Primary Completion Date: December 1, 2022
• Estimated Study Completion Date: December 20, 2022

Groups and Cohorts

Intervention Details:

• Other: None intervention is planned.
  None intervention is planned, just a survey.

Outcome Measures

Primary Outcome Measures :

1. Hypertension [ Time Frame: Through study completion, an average of 3 months ]
   Blood pressure >=140/90 mmHg or being taking antihypertensive medication.
2. Smoking [ Time Frame: Through study completion, an average of 3 months ]
   Percentage of participants that self-report current smoking
3. Hypercholesterolemia [ Time Frame: Through study completion, an average of 3 months ]
   Self-reported plasma high cholesterol levels.
4. 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.
5. 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"

Secondary Outcome Measures :

1. Previous myocardial infarction [ Time Frame: through study completion, an average of 3 months ]
   Self-reported history of myocardial infarction.
2. Previous stroke [ Time Frame: through study completion, an average of 3 months ]
   Self-reported history of stroke.
3. 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").
4. Healthy diet [ Time Frame: through study completion, an average of 3 months ]
   Self-reported consumption of vegetables and fruits.
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

Criteria

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

-

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

-

Contacts and Locations

Locations

Argentina

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

More Information

• Responsible Party: Fundacion GESICA
• ClinicalTrials.gov Identifier: NCT03734939
• Other Study ID Numbers: 0004
• First Posted: November 8, 2018
• Last Update Posted: July 30, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• 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:

cardiovascular risk factor; Slums; survey; cardiovascular disease

Additional relevant MeSH terms:

Cardiovascular Diseases