- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03328520
WILD 5 Wellness, A 30-Day Intervention
April 24, 2018 updated by: Beloit College
WILD 5 Wellness, A 30 Day Intervention in First Year Students at Beloit College
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative.
This program is called "WILD 5 Wellness: A 30-Day Intervention".
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Beloit, Wisconsin, United States, 53511
- Beloit College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students 18 years of age or older or 17 years of age with legal guardian written permission.
- Students enrolled in First Year Initiative Courses titled "Balance" or "Constructing Health"
Exclusion Criteria:
- Individuals who are pregnant or plan to get pregnant during the next 30 days.
- Students who are not enrolled in the First Year Initiative Courses titled "Balance" or "Constructing Health"
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: First Year Students in Wellness FYIs
|
Behaviors in 6 areas of wellness: Sleep, Social Connectedness, Exercise, Nutrition, Mindfulness and "HERO" (Happiness, Enthusiasm, Resilience, Optimism)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Day 0, Day 30+ 3 days (approximately)
|
PHQ-9 is a self reported depression scale.
It is a 9-item scale with scores ranging from 0-27.
Lower scores denote improvement.
|
Day 0, Day 30+ 3 days (approximately)
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Day 0, Day 30+ 3 days (approximately)
|
GAD-7 is a self-reported questionnaire used to assess anxiety symptoms.
It is a 7-item scale with scores ranging from 0-21.
Lower score denotes improvement.
|
Day 0, Day 30+ 3 days (approximately)
|
Change in the HERO Wellness Scale
Time Frame: Day 0, Day 30+ 3 days (approximately)
|
HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism.
It is a 5-item scale with scores ranging from 0-10.
Higher score denotes improvement.
|
Day 0, Day 30+ 3 days (approximately)
|
Change in World Health Organization-5 (WHO-5)
Time Frame: Day 0, Day 30+ 3 days (approximately)
|
WHO-5 is a brief scale that measures mental well-being.
It is a 5-item scale with scores ranging from 0-25.
Higher score denotes improvement.
|
Day 0, Day 30+ 3 days (approximately)
|
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
Time Frame: Day 0, Day 30+ 3 days (approximately)
|
CPFQ is a brief scale that measures cognitive and executive dysfunction.
It is a 7-item scale with scores ranging from 7-42.
Lower score denotes improvement.
|
Day 0, Day 30+ 3 days (approximately)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Post-Program Participant Questionnaire
Time Frame: Day 30+ 3 days (approximately)
|
The Post-Program Participant Questionnaire is a brief survey that captures participants'opinions about WILD 5 Wellness.
|
Day 30+ 3 days (approximately)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tara M Girard, BSN, Beloit College
- Principal Investigator: Suzanne Cox, PhD, Beloit College
- Principal Investigator: Laura Parmentier, PhD, Beloit College
- Principal Investigator: Saundra Jain, PsyD, LPC, Beloit College
- Principal Investigator: Rakesh Jain, MD, MPH, Beloit College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2017
Primary Completion (Actual)
November 29, 2017
Study Completion (Actual)
November 29, 2017
Study Registration Dates
First Submitted
October 20, 2017
First Submitted That Met QC Criteria
October 30, 2017
First Posted (Actual)
November 1, 2017
Study Record Updates
Last Update Posted (Actual)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 24, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 374
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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