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WILD 5 Wellness: A 30-Day Intervention

Primary Purpose

Wellness, Anxiety, Depression

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WILD 5 Wellness Interventions
Sponsored by
Beloit College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Wellness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • students 18 years of age or older
  • students enrolled in First Year Initiative Course titled, "Habits of Mind, Habits of Body."

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 Course titled, "Habits of Mind, Habits of Body".

Sites / Locations

  • Beloit College

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Participants

Arm Description

The participants in this arm will engage in the WILD 5 Wellness activities combining five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition.

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 is a self reported depression scale.
Change in Generalized Anxiety Disorder-7 (GAD-7)
GAD-7 is a self-reported questionnaire used to assess anxiety symptoms.
Change in The HERO Wellness Scale
The HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism.
Change in World Health Organization-5 (WHO-5)
WHO-5 is a brief scale that measures mental well-bring.
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
CPFQ is a brief scale that measures cognitive and executive dysfunction.

Secondary Outcome Measures

The Post-Program Participant Questionnaire
The Post-Program Participant Questionnaire is a brief survey that captures participants' opinions about WILD 5 Wellness: A 30-Day Intervention, and subjective ranking of their overall wellness.

Full Information

First Posted
August 29, 2017
Last Updated
April 24, 2018
Sponsor
Beloit College
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1. Study Identification

Unique Protocol Identification Number
NCT03272555
Brief Title
WILD 5 Wellness: A 30-Day Intervention
Official Title
WILD 5 Wellness: A 30-Day Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Failed study, participants showed no improvements
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
October 10, 2017 (Actual)
Study Completion Date
October 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beloit College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
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". Results for this study will be quantified through the use of standardized self-report questionnaires administered prior to and after students complete the WILD 5 program. Data will be collected to evaluate participants' adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention. It is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention for First Year Beloit College students.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wellness, Anxiety, Depression, Cognitive and Executive Dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Participants
Arm Type
Other
Arm Description
The participants in this arm will engage in the WILD 5 Wellness activities combining five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition.
Intervention Type
Other
Intervention Name(s)
WILD 5 Wellness Interventions
Intervention Description
Students enrolled in the study will be asked to complete activities in five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition for 30 days.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9)
Description
PHQ-9 is a self reported depression scale.
Time Frame
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
Title
Change in Generalized Anxiety Disorder-7 (GAD-7)
Description
GAD-7 is a self-reported questionnaire used to assess anxiety symptoms.
Time Frame
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
Title
Change in The HERO Wellness Scale
Description
The HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism.
Time Frame
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
Title
Change in World Health Organization-5 (WHO-5)
Description
WHO-5 is a brief scale that measures mental well-bring.
Time Frame
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
Title
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
Description
CPFQ is a brief scale that measures cognitive and executive dysfunction.
Time Frame
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
Secondary Outcome Measure Information:
Title
The Post-Program Participant Questionnaire
Description
The Post-Program Participant Questionnaire is a brief survey that captures participants' opinions about WILD 5 Wellness: A 30-Day Intervention, and subjective ranking of their overall wellness.
Time Frame
Day 31+/- 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: students 18 years of age or older students enrolled in First Year Initiative Course titled, "Habits of Mind, Habits of Body." 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 Course titled, "Habits of Mind, Habits of Body".
Facility Information:
Facility Name
Beloit College
City
Beloit
State/Province
Wisconsin
ZIP/Postal Code
53511
Country
United States

12. IPD Sharing Statement

Learn more about this trial

WILD 5 Wellness: A 30-Day Intervention

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