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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03328520
Other study ID # 374
Secondary ID
Status Completed
Phase N/A
First received October 20, 2017
Last updated April 24, 2018
Start date October 24, 2017
Est. completion date November 29, 2017

Study information

Verified date April 2018
Source Beloit College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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".


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 29, 2017
Est. primary completion date November 29, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
WILD 5 Wellness Intervention
Behaviors in 6 areas of wellness: Sleep, Social Connectedness, Exercise, Nutrition, Mindfulness and "HERO" (Happiness, Enthusiasm, Resilience, Optimism)

Locations

Country Name City State
United States Beloit College Beloit Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Beloit College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Patient Health Questionnaire-9 (PHQ-9) 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)
Primary Change in Generalized Anxiety Disorder-7 (GAD-7) 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)
Primary Change in the HERO Wellness Scale 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)
Primary Change in World Health Organization-5 (WHO-5) 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)
Primary Change in Cognitive and Physical Functioning Questionnaire (CPFQ) 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 The Post-Program Participant Questionnaire The Post-Program Participant Questionnaire is a brief survey that captures participants'opinions about WILD 5 Wellness. Day 30+ 3 days (approximately)
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