- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03027518
WILD 5 Wellness: A 30-Day Intervention
April 24, 2018 updated by: 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 Beloit College students.
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 (Group 1) or 30 days of inactive participation (Group 2), and again approximately 30 days later when the initially inactive group (Group 2) will have just completed their active participation in the WILD 5 program and the first WILD 5 group (Group 1) will be approximately 30 days out from completion of their WILD 5 active portion.
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 Beloit College students as compared to the control (inactive) group of students not participating in the Active program.
Study Overview
Study Type
Interventional
Enrollment (Actual)
88
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
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Beloit College student enrolled in one or more of the following Spring 2017 academic courses:
- Anthropology 201 01 "Research Designs: Sophomore Seminar in Anthropology"
- Health and Society 240 B1 "Sophomore Seminar in Health and Society"
- Spanish 218 "Health and Culture in the Spanish-Speaking World"
- Biology 373 "Neuroscience Research"
- Biology 215 "Emerging Diseases"
Exclusion Criteria:
- Individuals who are <18 years old
- Individuals who are acutely suicidal and/or actively psychotic
- Individuals who are pregnant or plan to get pregnant during the next 60 days, or who are not registered in one of the courses listed above.
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Group 1
Group 1 will be active in the WILD 5 Wellness program the first 30 days and inactive the 2nd 30 days.
|
Participants will be asked to voluntarily engage in integrated, prescriptive, and trackable wellness interventions combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
|
|
Other: Group 2
Group 2 will be inactive in the WILD 5 Wellness program the first 30 days and active the 2nd 30 days.
|
Participants will be asked to voluntarily engage in integrated, prescriptive, and trackable wellness interventions combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
WILD 5 Wellness Scale (W5WS), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
WILD 5 Wellness Elements (W5WE), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
WILD 5 Wellness Effort Scale (W5WES), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
WHO (World Health Organization) 5 Well-Being Index (1998 version), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Social Connectedness Scale (SCS), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Sleep Condition Indicator (SCI), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Sheehan Disability Scale (SDS), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Patient Health Questionnaire (PHQ-9), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Mindful Attention Awareness Scale (MAAS), Day to Day Experiences, Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
MIND ( Mediterranean-DASH Intervention for Neurodegenerative Delay)Diet, Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Generalized Anxiety Disorder (GAD-7), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Eating and Appraisal Due to Emotions and Stress Questionnaire (EADES), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Cognitive and Physical Functioning Questionnaire (CPFQ), Assessing Change
Time Frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
|
|
Post Program Participant Questionnaire
Time Frame: The end of the 30 day active participation in WILD 5 Wellness for each group (1 and 2)
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The end of the 30 day active participation in WILD 5 Wellness for each group (1 and 2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 6, 2017
Primary Completion (Actual)
April 18, 2017
Study Completion (Actual)
December 5, 2017
Study Registration Dates
First Submitted
January 17, 2017
First Submitted That Met QC Criteria
January 19, 2017
First Posted (Estimate)
January 23, 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
Other Study ID Numbers
- 302
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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