Cardiovascular DiseasesNCT03742219
Peru Longitudinal Study
A study testing Lifestyle Modification in people with Cardiovascular Diseases and Diabetes Mellitus, run by Ohio University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the change in disease prevalence over time in impoverished urban communities in Lima, Peru. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Hypertension
- What is being tested?
- Lifestyle Modification
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 861 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- adults who are unable to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Evaluation of Disease Prevalence in Impoverished Communities of Lima, Peru
The purpose of this study is to evaluate the change in disease prevalence over time in impoverished urban communities in Lima, Peru.
Read the 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.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Dyslipidemias, Overweight and Obesity
- Being tested
- Lifestyle Modification
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Dyslipidemias, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
weight in kilograms will be utilized to determine body mass index
Measured: yearly for 10 years
Systolic blood pressure
measured with a manual sphygmomanometer in millimeters of mercury
Measured: yearly for 10 years
Diastolic Blood Pressure
measured with a manual sphygmomanometer in millimeters of mercury
Measured: yearly for 10 years
glycosylated hemoglobin
measured in percent via fingerstick capillary blood and portable analyzer
Measured: periodically over 10 years
Total cholesterol
measured in percent via fingerstick capillary blood and portable analyzer
Measured: periodically over 10 years
Low-density lipoprotein cholesterol
measured in percent via fingerstick capillary blood and portable analyzer
Measured: periodically over 10 years
High density lipoprotein cholesterol
measured in percent via fingerstick capillary blood and portable analyzer
Measured: periodically over 10 years
Triglycerides
measured in percent via fingerstick capillary blood and portable analyzer
Measured: periodically over 10 years
Secondary outcomes (6)
Herth Hope Index
validated survey utilized to evaluate level of hope for the future
Measured: yearly for 10 years
Household hunger scale
validated survey to measure food insecurity
Measured: yearly for 10 years
Patient Health Questionnaire - 4 (PHQ-4)
used to evaluate depression and anxiety
Measured: yearly for 10 years
Exercise vital sign
the minutes of exercise during the last week
Measured: yearly for 10 years
Perceived Stress Scale
validated survey to evaluate level of stress
Measured: 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
Measured: yearly for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start5 Jun 2017
- Primary completion1 Oct 2019
- Study completion1 Mar 2020
Why it stopped: Low level of returning participants year by year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 861 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Drozek, Ohio University
- Investigators
- David S Drozek, DO, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742219
- Sponsor's protocol ID
- 17-X-88
- Status last verified
- Mar 2021
- First submitted
- 12 Nov 2018
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Disease Prevalence in Impoverished Communities of Lima, Peru
- ClinicalTrials.gov ID
- NCT03742219
- Acronym / sponsor ID
- 17-X-88
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Dyslipidemias, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low level of returning participants year by year.
- Enrolment
- 861 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the change in disease prevalence over time in impoverished urban communities in Lima, Peru.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle ModificationImpoverished 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- adults who are unable to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Modification1. 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. | Behavioural | Lifestyle Intervention |
Primary outcome
Weight
Time frame: yearly for 10 years
weight in kilograms will be utilized to determine body mass index
Systolic blood pressure
Time frame: yearly for 10 years
measured with a manual sphygmomanometer in millimeters of mercury
Diastolic Blood Pressure
Time frame: yearly for 10 years
measured with a manual sphygmomanometer in millimeters of mercury
glycosylated hemoglobin
Time frame: periodically over 10 years
measured in percent via fingerstick capillary blood and portable analyzer
Total cholesterol
Time frame: periodically over 10 years
measured in percent via fingerstick capillary blood and portable analyzer
Low-density lipoprotein cholesterol
Time frame: periodically over 10 years
measured in percent via fingerstick capillary blood and portable analyzer
High density lipoprotein cholesterol
Time frame: periodically over 10 years
measured in percent via fingerstick capillary blood and portable analyzer
Triglycerides
Time frame: periodically over 10 years
measured in percent via fingerstick capillary blood and portable analyzer
6 secondary outcomes
Herth Hope Index
Time frame: yearly for 10 years
Household hunger scale
Time frame: yearly for 10 years
Patient Health Questionnaire - 4 (PHQ-4)
Time frame: yearly for 10 years
Exercise vital sign
Time frame: yearly for 10 years
Perceived Stress Scale
Time frame: yearly for 10 years
24 hour dietary recall
Time frame: yearly for 10 years
Results and safety
The study was stopped early (reason given: Low level of returning participants year by year.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Drozek, DO principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification in people with Cardiovascular Diseases and Diabetes Mellitus, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low level of returning participants year by year.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: yearly for 10 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.