Peru Longitudinal Study

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

Detailed Description
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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.

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

Conditions
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Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Dyslipidemias, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Lifestyle Modification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>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. | Behavioral: Lifestyle Modification<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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