NCT03742219

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
861

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

November 12, 2018

Last Update Submit

March 10, 2021

Conditions

Cardiovascular DiseasesDiabetes MellitusHypertensionDyslipidemiasOverweight and Obesity

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (6)

  • Herth Hope Index

    yearly for 10 years

  • Household hunger scale

    yearly for 10 years

  • Patient Health Questionnaire - 4 (PHQ-4)

    yearly for 10 years

  • Exercise vital sign

    yearly for 10 years

  • Perceived Stress Scale

    yearly for 10 years

  • +1 more secondary outcomes

Study Arms (1)

Lifestyle Intervention

EXPERIMENTAL

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

Interventions

Lifestyle ModificationBEHAVIORAL

1. 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. 2. 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.

Lifestyle Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • adults who are unable to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusHypertensionDyslipidemiasOverweightObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesLipid Metabolism DisordersOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David S Drozek, DO

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 15, 2018

Study Start

June 5, 2017

Primary Completion

October 1, 2019

Study Completion

March 1, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)