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

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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