Peru Longitudinal Study

• Sponsor: Ohio University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03742219
• Collaborator: (none)
• Enrollment: 861
• Location: 1
• Arm: 1
• Actual Duration (Months): 32.9
• Patients Per Site Per Month: 26.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Diabetes Mellitus; Hypertension; Dyslipidemias; Overweight and Obesity	Behavioral: Lifestyle Modification	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 861 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Longitudinal Evaluation of Disease Prevalence in Impoverished Communities of Lima, Peru
• Actual Study Start Date: Jun 5, 2017
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Lifestyle Intervention 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; 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.

Outcome Measures

Primary Outcome Measures

1. Weight [yearly for 10 years]

   weight in kilograms will be utilized to determine body mass index

2. Systolic blood pressure [yearly for 10 years]

   measured with a manual sphygmomanometer in millimeters of mercury

3. Diastolic Blood Pressure [yearly for 10 years]

   measured with a manual sphygmomanometer in millimeters of mercury

4. glycosylated hemoglobin [periodically over 10 years]

   measured in percent via fingerstick capillary blood and portable analyzer

5. Total cholesterol [periodically over 10 years]

   measured in percent via fingerstick capillary blood and portable analyzer

6. Low-density lipoprotein cholesterol [periodically over 10 years]

   measured in percent via fingerstick capillary blood and portable analyzer

7. High density lipoprotein cholesterol [periodically over 10 years]

   measured in percent via fingerstick capillary blood and portable analyzer

8. Triglycerides [periodically over 10 years]

   measured in percent via fingerstick capillary blood and portable analyzer

Secondary Outcome Measures

1. Herth Hope Index [yearly for 10 years]

   validated survey utilized to evaluate level of hope for the future

2. Household hunger scale [yearly for 10 years]

   validated survey to measure food insecurity

3. Patient Health Questionnaire - 4 (PHQ-4) [yearly for 10 years]

   used to evaluate depression and anxiety

4. Exercise vital sign [yearly for 10 years]

   the minutes of exercise during the last week

5. Perceived Stress Scale [yearly for 10 years]

   validated survey to evaluate level of stress

6. 24 hour dietary recall [yearly for 10 years]

   report of all foods consumed in the last 24 hours, which will be utilized to determine the nutritional value of dietary intake

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio University	Athens	Ohio	United States	45701

Sponsors and Collaborators

• Ohio University

Investigators

• Principal Investigator: David S Drozek, DO, Ohio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Drozek, Associate Professor, Ohio University
• ClinicalTrials.gov Identifier: NCT03742219
• Other Study ID Numbers: 17-X-88
• First Posted: Nov 15, 2018
• Last Update Posted: Mar 15, 2021
• Last Verified: Mar 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
• Additional relevant MeSH terms: Cardiovascular Diseases; Dyslipidemias; Overweight

Study Results

No Results Posted as of Mar 15, 2021