Wellness Initiative at New York University

NCT03120767 | Withdrawn DMC

• 1 other identifier: 16-02124
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Health Promotion

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale

  measures subjective experience of stress

  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

  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

  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

  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

  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

  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)

Study Arms (3)

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)

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

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.

Interventions

Risk and Resilience BEHAVIORAL

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.

Condition 1; Condition 2

Coordinated Wellness Programming BEHAVIORAL

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.

Condition 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• a student at NYU (Ascertained by their nyu.edu email address)
• residing in Founder's Hall (corroborated by NYU Housing)

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Interventions

Risk

Intervention Hierarchy (Ancestors)

Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jess Shatkin, MD, MPH

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 19, 2017
• Study Start: September 1, 2017
• Primary Completion: April 24, 2019
• Study Completion: April 30, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share