Health BehaviorNCT02533804
The Lake Nona Life Project
An observational study of Health Behavior and Quality of Life, run by University of Central Florida at 1 site in United States.
Trial summary
The Lake Nona Life Project aims to examine the health and wellness of participants over the course of multiple years, focusing on the links between health and wellness, longevity, quality of life, and human performance. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Quality of Life, Aging
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2014to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults ages 18 and older living and/or working in the Lake Nona Community (proper) of Orlando, Florida.
Who may be able to join
- 18 years or older
- Live and/or work in the Lake Nona Community (proper)
- Able to provide informed consent
- Able to speak and read English
Who cannot join
- Unable to speak or communicate in English
- Living outside of the LNLP study map
- Cognitive impairment that would not allow survey completion
- Unable to speak and read English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashley Kohrt contact
Jasmine Jones contact
United States1 site, 1 recruiting
- Recruiting
Lake Nona Institute
Orlando, Florida, 32827
Ashley Kohrt, ashley.kohrt@flhosp.org
Jasmine Jones, jasmine.jones@flhosp.org
About this study
Official title: A Community Epidemiology Study Evaluating the Factors Influencing Overall Health and Wellness
The Lake Nona Life Project aims to examine the health and wellness of participants over the course of multiple years, focusing on the links between health and wellness, longevity, quality of life, and human performance.
Read the detailed description
The Lake Nona Life Project is a community health and wellness research project of the Lake Nona Institute (LNI), carried out by the Lake Nona Medical City Residents and Partners (the Researchers), and sponsored by Florida Hospital. The project is designed to study patterns, predictors and strategies for improving human health and wellness. Data will be obtained over many years using surveys/interviews, medical tests, and health information from 3rd parties (i.e., health care claims data) obtained with participant permission.
- Conditions
- Health Behavior, Quality of Life, Aging
- Keywords
- health, wellness, life expectancy, quality of life, performance, religion, skin, cardiovascular, joints, bone, respiration, pain, nervous system diseases, oral health, behavior, child, depression, mood, panic, sleep
- Medical subject headings
- Health Behavior, Respiratory Aspiration, Pain, Nervous System Diseases, Behavior, Depression, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life over 10 Years
Participants will self report on an Investigator created questionnaire regarding life satisfaction, stress and life events. Responses will be provided on a five point Likert Scale.
Measured: 20 years
Secondary outcomes (2)
Demographics
Participants will self report demographic information consisting of questions related to age, gender and race.
Measured: 20 years
Medical History
Participants will self report medical history and chronic conditions.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start31 Dec 2014
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Lake Nona Institute, DataStat, Inc., Mytrus, Inc.
- Responsible party
- Sponsor
- Investigators
- Patricia Robinson, Principal investigator, Center for CREATION Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533804
- Sponsor's protocol ID
- 1166275
- Status last verified
- Dec 2024
- First submitted
- 1 Jun 2015
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Institute for Health Metrics and Evaluation. 2013. Financing Global Health 2012: The End of the Golden Age? Seattle, WA: IHME http://www.healthmetricsandevaluation.org/publications/policy-report/financing-global-health-2012-end-golden-age
World Health Organization. (2012). World Health Statistics 2012. Geneva, Switzerland: World Health Organization http://www.who.int/gho/publications/world_health_statistics/EN_WHS2012_TOC.pdf?ua=1
United Nations, Department of Economic and Social Affairs, Population Division. (2011). World population prospects, the 2010 revision. http://esa.un.org/unpd/wpp/Documentation/WPP%202010%20publications.htm
Organization for Exonomic Co-operation and Development. (2012). OECD Health Data 2012: U. S. Health Care System from an International Perspective [PDF document]. Retrieved from http://www.oecd.org/health/HealthSpendingInUSA_HealthData2012.pdf
US Central Intelligence Agency. (2014). The World Factbook, Country Comparison: Life Expectancy at Birth. Retrieved from https://www.cia.gov/library/publications/the-world-factbook/rankorder/2102rank.html
Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117.
PubMed 24979972Rand Health. (2000). Projection of chronic illness prevalence and cost inflation. Santa Monica, CA: Wu, S., Y., Green, A.
Kung HC, Hoyert DL, Xu J, Murphy SL. Deaths: final data for 2005. Natl Vital Stat Rep. 2008 Apr 24;56(10):1-120.
PubMed 18512336National Center for Chronic Disease Prevention and Health Promotion. (2012). Chronic Diseases and Health Promotion. Retrieved from http://www.cdc.gov/chronicdisease/overview/index.htm
Adams PF, Kirzinger WK, Martinez ME. Summary health statistics for the u.s. Population: national health interview survey, 2011. Vital Health Stat 10. 2012 Dec;(255):1-110.
PubMed 25116371National Heart, Lung, and Blood Institute, Boston University. (2014). The Framingham Heart Study Bibliography. Retrieved from http://www.framinghamheartstudy.org/fhs-bibliography/index.php
Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc (Wash). 2003 Mar-Apr;43(2):173-84. doi: 10.1331/108658003321480713.
PubMed 12688435Bunting BA, Cranor CW. The Asheville Project: long-term clinical, humanistic, and economic outcomes of a community-based medication therapy management program for asthma. J Am Pharm Assoc (2003). 2006 Mar-Apr;46(2):133-47. doi: 10.1331/154434506776180658.
PubMed 16602223Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc (2003). 2008 Jan-Feb;48(1):23-31. doi: 10.1331/JAPhA.2008.07140.
PubMed 18192127Luepker RV, Murray DM, Jacobs DR Jr, Mittelmark MB, Bracht N, Carlaw R, Crow R, Elmer P, Finnegan J, Folsom AR, et al. Community education for cardiovascular disease prevention: risk factor changes in the Minnesota Heart Health Program. Am J Public Health. 1994 Sep;84(9):1383-93. doi: 10.2105/ajph.84.9.1383.
PubMed 8092360
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Epidemiology Study Evaluating the Factors Influencing Overall Health and Wellness
- ClinicalTrials.gov ID
- NCT02533804
- Acronym / sponsor ID
- 1166275
- Conditions
- Health Behavior, Quality of Life, Aging
- Keywords
- health, wellness, life expectancy, quality of life, performance, religion, skin, cardiovascular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Lake Nona Institute, DataStat, Inc., Mytrus, Inc.
- Study start
- 31 Dec 2014 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- 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 Lake Nona Life Project aims to examine the health and wellness of participants over the course of multiple years, focusing on the links between health and wellness, longevity, quality of life, and human performance.
Detailed description
The Lake Nona Life Project is a community health and wellness research project of the Lake Nona Institute (LNI), carried out by the Lake Nona Medical City Residents and Partners (the Researchers), and sponsored by Florida Hospital. The project is designed to study patterns, predictors and strategies for improving human health and wellness. Data will be obtained over many years using surveys/interviews, medical tests, and health information from 3rd parties (i.e., health care claims data) obtained with participant permission.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ages 18 and older living and/or working in the Lake Nona Community (proper) of Orlando, Florida.
Key inclusion criteria (4 listed)
- 18 years or older
- Live and/or work in the Lake Nona Community (proper)
- Able to provide informed consent
- Able to speak and read English
Key exclusion criteria (4 listed)
- Unable to speak or communicate in English
- Living outside of the LNLP study map
- Cognitive impairment that would not allow survey completion
- Unable to speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life over 10 Years
Time frame: 20 years
Participants will self report on an Investigator created questionnaire regarding life satisfaction, stress and life events. Responses will be provided on a five point Likert Scale.
2 secondary outcomes
Demographics
Time frame: 20 years
Medical History
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- BackgroundInstitute for Health Metrics and Evaluation. 2013. Financing Global Health 2012: The End of the Golden Age? Seattle, WA: IHME http://www.healthmetricsandevaluation.org/publications/policy-report/financing-global-health-2012-end-golden-age
- BackgroundWorld Health Organization. (2012). World Health Statistics 2012. Geneva, Switzerland: World Health Organization http://www.who.int/gho/publications/world_health_statistics/EN_WHS2012_TOC.pdf?ua=1
- BackgroundUnited Nations, Department of Economic and Social Affairs, Population Division. (2011). World population prospects, the 2010 revision. http://esa.un.org/unpd/wpp/Documentation/WPP%202010%20publications.htm
- BackgroundOrganization for Exonomic Co-operation and Development. (2012). OECD Health Data 2012: U. S. Health Care System from an International Perspective [PDF document]. Retrieved from http://www.oecd.org/health/HealthSpendingInUSA_HealthData2012.pdf
- BackgroundUS Central Intelligence Agency. (2014). The World Factbook, Country Comparison: Life Expectancy at Birth. Retrieved from https://www.cia.gov/library/publications/the-world-factbook/rankorder/2102rank.html
- Background: PubMed 24979972Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117.
- BackgroundRand Health. (2000). Projection of chronic illness prevalence and cost inflation. Santa Monica, CA: Wu, S., Y., Green, A.
- Background: PubMed 18512336Kung HC, Hoyert DL, Xu J, Murphy SL. Deaths: final data for 2005. Natl Vital Stat Rep. 2008 Apr 24;56(10):1-120.
- BackgroundNational Center for Chronic Disease Prevention and Health Promotion. (2012). Chronic Diseases and Health Promotion. Retrieved from http://www.cdc.gov/chronicdisease/overview/index.htm
- Background: PubMed 25116371Adams PF, Kirzinger WK, Martinez ME. Summary health statistics for the u.s. Population: national health interview survey, 2011. Vital Health Stat 10. 2012 Dec;(255):1-110.
- BackgroundNational Heart, Lung, and Blood Institute, Boston University. (2014). The Framingham Heart Study Bibliography. Retrieved from http://www.framinghamheartstudy.org/fhs-bibliography/index.php
- Background: PubMed 12688435Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc (Wash). 2003 Mar-Apr;43(2):173-84. doi: 10.1331/108658003321480713.
- General Information/RegistrationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Ashley Kohrt contact
Jasmine Jones contact
Patricia Robinson principal investigator
Center for CREATION Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior and Quality of Life, run by University of Central Florida 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Kohrt (ashley.kohrt@flhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life over 10 Years (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533804, which also lists 18 linked publications.
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 6 Dec 2024.