Health PromotionWINNCT03120767
Wellness Initiative at New York University
A study testing Risk and Resilience and Coordinated Wellness Programming in people with Health Promotion, run by NYU Langone Health.
Trial summary
The goal of this study is to evaluate the effect on first-year college students of participation in a 14-week seminar course and residential housing wellness activities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Risk and Resilience and Coordinated Wellness Programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 30 Apr 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old
- a student at NYU (Ascertained by their nyu.edu email address)
- residing in Founder's Hall (corroborated by NYU Housing)
Who cannot join
- Provided the potential participant has met the above inclusion criteria, there are no exclusion criteria.
About this study
The goal of this study is to evaluate the effect on first-year college students of participation in a 14-week seminar course and residential housing wellness activities.
Read the detailed description
WIN has been designed to enhance student wellness and personal success during college and after graduation from New York University. The program is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology and aims to increase resilience within students by building knowledge and skills in key areas proven to enhance wellness, including communication, executive functioning, social support, cognitive behavioral techniques, stress management, emotion regulation, and sense of purpose. WIN will achieve these aims by teaching this knowledge and skills to students in a class ("Risk and Resilience") and via participation in various activities within a residential Living and Learning Community. Students will not only receive training and support in establishing healthy exercise, nutrition, and sleep habits, students will also be taught core components of cognitive-behavior therapy, mindfulness, and organizational skills training.
In tandem with the implementation of WIN,the effectiveness of the program will be evaluated. A research study will offer benefits: first, it will provide the college with data for future estimations of student interest to assist in further expanding the scope of wellness; and second, it will provide the Child Study Center at NYU with the opportunity to explore the impact of teaching resilience skills to first-year college students and to modify, if appropriate course content to improve effectiveness.
A longitudinal study at NYU beginning in Fall of 2017 of 175 first-year students, who are randomly assigned to one of three conditions after consenting to participate in the research.
200 participants will be recruited during Spring and Summer of 2017 from the incoming first-year students who will begin classes in Fall 2017. It is anticipated that of the 200 enrolled via electronic assent prior to the beginning of the fall 2017 semester, some may not attend NYU and some may rethink the decision to participate and then not follow up with providing informed consent. As such, there will be over-enrolling via preliminary electronic assent so that the following enrollment can be achieved:
175 students will be assigned randomly into one of three conditions:
- 50 students to Condition 1 (enrolled in the Risk and Resilience course during Fall 2017 and directly encouraged to participate in the Founders Living and Learning Community wellness activities for the Fall of 2017)
- 75 students to Condition 2 (waitlisted to be enrolled in the Rick and Resilience course until Spring 2018, and not directly encouraged to participate in the WIN Living and Learning Community wellness activities)
- 50 students to Condition 3 (a control group that receives none of the interventions during the first year). This group will instead receive an online pamphlet that contains a number of wellness tips and advice for first-year students. Participants have access to the WIN Living and Learning Community wellness activities in Fall of 2017 and Spring of 2018, but are not directly encouraged to participate.
The progress of these 175 students will be measured at frequent intervals throughout the first and subsequent years at college, beginning with a baseline assessment battery once participants provide written informed consent in Fall of 2017, followed by a second survey in Winter 2018, another survey at the end of the academic year (May 2018), and then annually thereafter. In addition to collecting demographic factors (age, gender, race, ethnicity, and relationship status), the study will utilize empirically-based measures that will be self-reported by the students, using an online survey tool. These measures will capture a series of attributes that have been demonstrated as being important factors in psychological well-being, including:
- Perceived stress
- Depressive symptoms
- Anxiety symptoms
- Dysfunctional attitudes
- Risk behaviors (smoking, sexual activity, alcohol and drug usage, etc.)
- Coping skills
- Interpersonal communication
- Use of Cognitive-Behavioral Therapy techniques
- Health behaviors (exercise, nutrition, sleep, etc.)
Additional data will be collected to measure academic achievement, such as grade-point average and persistence in college.
- Conditions
- Health Promotion
- Being tested
- Risk and Resilience, Coordinated Wellness Programming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk and ResilienceBehavioural
The "Risk and Resilience" course is a 14-week undergraduate seminar that is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology. Students will learn about key areas proven to enhance wellness, including communication, executive functioning, social support, self-efficacy, emotion regulation, and sense of purpose. Students will learn about healthy exercise, nutrition, and sleep habits, and develop skills in core components of cognitive-behavior therapy, mindfulness, and organizational skills.
Coordinated Wellness ProgrammingBehavioural
During the Fall of 2017, wellness activities will be provided within Founders Hall that support the theories and skills being taught in the "Risk and Resilience" course occurring in the same semester.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | enrolled in the Risk and Resilience course during Fall 2017 and directly encouraged to participate in the Founders Living and Learning Community wellness activities for the Fall of 2017 (Coordinated Wellness Programming) Receives: Behavioral: Risk and Resilience; Behavioral: Coordinated Wellness Programming |
| Condition 2 | Active comparator | enrolled in the Risk and Resilience course in Spring 2018, and not directly encouraged to participate in the WIN Living and Learning Community wellness activities Receives: Behavioral: Risk and Resilience |
| Condition 3 | No intervention | a control group that receives none of the interventions during the first year. This group will instead receive an online pamphlet that contains a number of wellness tips and advice for first-year students. Condition 3 participants have access to the WIN Living and Learning Community wellness activities in Fall of 2017 and Spring of 2018, but are not directly encouraged to participate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
measures subjective experience of stress
Measured: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Secondary outcomes (7)
Center for Epidemiologic Studies Depression Scale
Measures clinically significant depressive symptomatology
Measured: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months))
Beck Anxiety Inventory
Measures clinically significant anxious symptomatology
Measured: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Dysfunctional Attitudes Scale
Measures to what extent respondents hold attitudes or beliefs that hinder performance
Measured: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
American College Health Association-National College Health Assessment II
a national college survey that asks about a variety of college student behaviors, such as risk-taking behaviors, alcohol consumption, nutrition, etc.
Measured: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Brief Cope
measures methods by which respondents cope with stressors in their lives
Measured: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Interpersonal Communication Skills Inventory
measures interpersonal components of effective communication: an adequate self-concept; the ability to be a good listener; the skills of expressing one's thoughts and ideas clearly; being able to cope with emotions; and the willingness of disclose oneself to others
Measured: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Cognitive-Behavioral Therapy Skills Questionnaire
measures use of Cognitive-Behavioral Therapy techniques: behavioral activation and cognitive restructuring
Measured: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Sep 2017
- Primary completion24 Apr 2019
- Study completion30 Apr 2019
Why it stopped: Due to inability to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jess Shatkin, MD, MPH, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120767
- Sponsor's protocol ID
- 16-02124
- Acronym
- WIN
- Status last verified
- Apr 2019
- First submitted
- 24 Mar 2017
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness Initiative at New York University
- ClinicalTrials.gov ID
- NCT03120767
- Acronym / sponsor ID
- WIN / 16-02124
- Conditions
- Health Promotion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to inability to enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 19 Apr 2017 (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 goal of this study is to evaluate the effect on first-year college students of participation in a 14-week seminar course and residential housing wellness activities.
Detailed description
WIN has been designed to enhance student wellness and personal success during college and after graduation from New York University. The program is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology and aims to increase resilience within students by building knowledge and skills in key areas proven to enhance wellness, including communication, executive functioning, social support, cognitive behavioral techniques, stress management, emotion regulation, and sense of purpose. WIN will achieve these aims by teaching this knowledge and skills to students in a class ("Risk and Resilience") and via participation in various activities within a residential Living and Learning Community. Students will not only receive training and support in establishing healthy exercise, nutrition, and sleep habits, students will also be taught core components of cognitive-behavior therapy, mindfulness, and organizational skills training.
In tandem with the implementation of WIN,the effectiveness of the program will be evaluated. A research study will offer benefits: first, it will provide the college with data for future estimations of student interest to assist in further expanding the scope of wellness; and second, it will provide the Child Study Center at NYU with the opportunity to explore the impact of teaching resilience skills to first-year college students and to modify, if appropriate course content to improve effectiveness.
A longitudinal study at NYU beginning in Fall of 2017 of 175 first-year students, who are randomly assigned to one of three conditions after consenting to participate in the research.
200 participants will be recruited during Spring and Summer of 2017 from the incoming first-year students who will begin classes in Fall 2017. It is anticipated that of the 200 enrolled via electronic assent prior to the beginning of the fall 2017 semester, some may not attend NYU and some may rethink the decision to participate and then not follow up with providing informed consent. As such, there will be over-enrolling via preliminary electronic assent so that the following enrollment can be achieved:
175 students will be assigned randomly into one of three conditions:
- 50 students to Condition 1 (enrolled in the Risk and Resilience course during Fall 2017 and directly encouraged to participate in the Founders Living and Learning Community wellness activities for the Fall of 2017)
- 75 students to Condition 2 (waitlisted to be enrolled in the Rick and Resilience course until Spring 2018, and not directly encouraged to participate in the WIN Living and Learning Community wellness activities)
- 50 students to Condition 3 (a control group that receives none of the interventions during the first year). This group will instead receive an online pamphlet that contains a number of wellness tips and advice for first-year students. Participants have access to the WIN Living and Learning Community wellness activities in Fall of 2017 and Spring of 2018, but are not directly encouraged to participate.
The progress of these 175 students will be measured at frequent intervals throughout the first and subsequent years at college, beginning with a baseline assessment battery once participants provide written informed consent in Fall of 2017, followed by a second survey in Winter 2018, another survey at the end of the academic year (May 2018), and then annually thereafter. In addition to collecting demographic factors (age, gender, race, ethnicity, and relationship status), the study will utilize empirically-based measures that will be self-reported by the students, using an online survey tool. These measures will capture a series of attributes that have been demonstrated as being important factors in psychological well-being, including:
- Perceived stress
- Depressive symptoms
- Anxiety symptoms
- Dysfunctional attitudes
- Risk behaviors (smoking, sexual activity, alcohol and drug usage, etc.)
- Coping skills
- Interpersonal communication
- Use of Cognitive-Behavioral Therapy techniques
- Health behaviors (exercise, nutrition, sleep, etc.)
Additional data will be collected to measure academic achievement, such as grade-point average and persistence in college.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Risk and Resilience, Behavioral: Coordinated Wellness Programmingenrolled in the Risk and Resilience course during Fall 2017 and directly encouraged to participate in the Founders Living and Learning Community wellness activities for the Fall of 2017 (Coordinated Wellness Programming) |
| Condition 2 | Active comparator | Behavioral: Risk and Resilienceenrolled in the Risk and Resilience course in Spring 2018, and not directly encouraged to participate in the WIN Living and Learning Community wellness activities |
| Condition 3 | No intervention | –a control group that receives none of the interventions during the first year. This group will instead receive an online pamphlet that contains a number of wellness tips and advice for first-year students. Condition 3 participants have access to the WIN Living and Learning Community wellness activities in Fall of 2017 and Spring of 2018, but are not directly encouraged to participate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old
- a student at NYU (Ascertained by their nyu.edu email address)
- residing in Founder's Hall (corroborated by NYU Housing)
Key exclusion criteria (1 listed)
- Provided the potential participant has met the above inclusion criteria, there are no exclusion criteria.
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 |
|---|---|---|
| Risk and ResilienceThe "Risk and Resilience" course is a 14-week undergraduate seminar that is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology. Students will learn about key areas proven to enhance wellness, including communication, executive functioning, social support, self-efficacy, emotion regulation, and sense of purpose. Students will learn about healthy exercise, nutrition, and sleep habits, and develop skills in core components of cognitive-behavior therapy, mindfulness, and organizational skills. | Behavioural | Condition 1, Condition 2 |
| Coordinated Wellness ProgrammingDuring the Fall of 2017, wellness activities will be provided within Founders Hall that support the theories and skills being taught in the "Risk and Resilience" course occurring in the same semester. | Behavioural | Condition 1 |
Primary outcome
Perceived Stress Scale
Time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
measures subjective experience of stress
7 secondary outcomes
Center for Epidemiologic Studies Depression Scale
Time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months))
Beck Anxiety Inventory
Time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Dysfunctional Attitudes Scale
Time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
American College Health Association-National College Health Assessment II
Time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Brief Cope
Time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Interpersonal Communication Skills Inventory
Time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Cognitive-Behavioral Therapy Skills Questionnaire
Time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Individual participant dataSharing planned: No
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Randomized Controlled Trial Of Text Messages To Increase Pneumococcal Vaccination In Adults In Chile.
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Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults
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PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.
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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.
Jess Shatkin, MD, MPH principal investigator
New York University
Questions about this trial
What is this clinical trial studying?
A study testing Risk and Resilience and Coordinated Wellness Programming in people with Health Promotion, run by NYU Langone Health.
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: withdrawn, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Perceived Stress Scale (time frame: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)). 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 2 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.