Health BehaviorCHAT-CSNCT03648164
CREATION Health Assessment Tool for College Students
An observational study of Health Behavior and Well Being, run by AdventHealth at 5 sites in United States.
Trial summary
CREATION Health encompasses eight whole-person care principles: Choice, Rest, Environment, Activity, Trust, Interpersonal-Relationships, Outlook, and Nutrition. An existing initial tool consisting of 74 items related to the eight CREATION Health principles and college students' wellbeing were generated by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Well Being
- What is being tested?
- CHAT-CS Survey
- How many people
- 474 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2018to 9 Jul 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult undergraduate students in college/university
Who may be able to join
- Undergraduate college student
- Age 18 or more years
- Must be able to read and understand ENglish
Who cannot join
- Have previously taken the University Wellness Assessment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Andrews University
Berrien Springs, Michigan, 49104
Southern Adventist University
Collegedale, Tennessee, 37315
Oakwood University
Huntsville, Alabama, 35896
Kettering College
Kettering, Ohio, 45429
Union College
Lincoln, Nebraska, 68506
About this study
Official title: Development and Psychometric Test of CREATION Health Assessment Tool for College Students
CREATION Health encompasses eight whole-person care principles: Choice, Rest, Environment, Activity, Trust, Interpersonal-Relationships, Outlook, and Nutrition. An existing initial tool consisting of 74 items related to the eight CREATION Health principles and college students' wellbeing were generated by subject/methodology experts. To develop the CREATION Health Assessment Tool for College Students (CHAT-CS), this initial tool needs to be finalized through item reductions and validations in the population of college students.
Read the detailed description
CREATION Health encompasses eight whole-person care principles: Choice, Rest, Environment, Activity, Trust, Interpersonal-Relationships, Outlook, and Nutrition.
Based on these principles, a health and wellness program, CREATION Health Wellness Program was developed. Since then various education/training plans using mind-body-spirit approaches have been implemented for different populations. Recently the Adventist Health System has plan to assess Adventist university students' health wellbeing and develop strategies to intervene and thus improve their overall wellbeing. However, literature review found that measures of these eight CREATION Health principles are often discrete and inconsistent. Therefore, there is an urgent need for a comprehensive, consistent assessment tool.
An existing initial tool consisting of 74 items related to the eight CREATION Health principles and college students' wellbeing were generated by subject/methodology experts. To develop the CREATION Health Assessment Tool for College Students (CHAT-CS), this initial tool needs to be finalized through item reductions and validations in the population of college students.
- Conditions
- Health Behavior, Well Being
- Being tested
- CHAT-CS Survey
- Keywords
- well-being, health behavior, choice, rest, environment, activity, trust, interpersonal relationships, outlook, nutrition, survey, student, college, university
- Medical subject headings
- Health Behavior, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAT-CS SurveyOther
Students will complete a computer-based survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish reliability using Cronbach's alpha
Cronbach's (alpha) is a coefficient of reliability. The theoretical l value of the Cronbach's alpha varies from 0 to 1. A higher score indicates higher reliability.
Measured: Through December, 2018
Secondary outcomes (1)
Item deduction
- If an item is highly correlated with another item (item redundancy), consider removing one of the two items (correlation >.70)
- If an item is not correlated (<.30) with other items, then consider eliminating this item
- If an individual item has a weak loading on all factors (.39 or less), consider removing
- If an item has a high loading (.40 or more) on multiple factors, consider modification or elimination
Measured: Through May, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Oct 2018
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Other
- Time perspective
- Prospective
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Tao, PhD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648164
- Sponsor's protocol ID
- 1238224
- Acronym
- CHAT-CS
- Status last verified
- Feb 2020
- First submitted
- 22 Aug 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johanson, G.A. and Brooks, G.P. (2010) Initial scare development sample size for pilot studies. Educational and Psychological Measurement, 70, 394-400.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Psychometric Test of CREATION Health Assessment Tool for College Students
- ClinicalTrials.gov ID
- NCT03648164
- Acronym / sponsor ID
- CHAT-CS / 1238224
- Conditions
- Health Behavior, Well Being
- Keywords
- well-being, health behavior, choice, rest, environment, activity, trust, interpersonal relationships
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 27 Aug 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.
CREATION Health encompasses eight whole-person care principles: Choice, Rest, Environment, Activity, Trust, Interpersonal-Relationships, Outlook, and Nutrition. An existing initial tool consisting of 74 items related to the eight CREATION Health principles and college students' wellbeing were generated by subject/methodology experts. To develop the CREATION Health Assessment Tool for College Students (CHAT-CS), this initial tool needs to be finalized through item reductions and validations in the population of college students.
Detailed description
CREATION Health encompasses eight whole-person care principles: Choice, Rest, Environment, Activity, Trust, Interpersonal-Relationships, Outlook, and Nutrition.
Based on these principles, a health and wellness program, CREATION Health Wellness Program was developed. Since then various education/training plans using mind-body-spirit approaches have been implemented for different populations. Recently the Adventist Health System has plan to assess Adventist university students' health wellbeing and develop strategies to intervene and thus improve their overall wellbeing. However, literature review found that measures of these eight CREATION Health principles are often discrete and inconsistent. Therefore, there is an urgent need for a comprehensive, consistent assessment tool.
An existing initial tool consisting of 74 items related to the eight CREATION Health principles and college students' wellbeing were generated by subject/methodology experts. To develop the CREATION Health Assessment Tool for College Students (CHAT-CS), this initial tool needs to be finalized through item reductions and validations in the population of college students.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult undergraduate students in college/university
Key inclusion criteria (3 listed)
- Undergraduate college student
- Age 18 or more years
- Must be able to read and understand ENglish
Key exclusion criteria (1 listed)
- Have previously taken the University Wellness Assessment
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 |
|---|---|---|
| CHAT-CS SurveyStudents will complete a computer-based survey | Other | – |
Primary outcome
Establish reliability using Cronbach's alpha
Time frame: Through December, 2018
Cronbach's (alpha) is a coefficient of reliability. The theoretical l value of the Cronbach's alpha varies from 0 to 1. A higher score indicates higher reliability.
1 secondary outcome
Item deduction
Time frame: Through May, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- BackgroundJohanson, G.A. and Brooks, G.P. (2010) Initial scare development sample size for pilot studies. Educational and Psychological Measurement, 70, 394-400.
- 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.
Hong Tao, PhD principal investigator
AdventHealth
5 sites 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 Well Being, run by AdventHealth at 5 sites 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 3 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: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Establish reliability using Cronbach's alpha (time frame: Through December, 2018). 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 NCT03648164, which also lists 1 linked publication.
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 7 Feb 2020.