- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03272555
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 First Year Beloit College students self-selected into a wellness focused first year initiative.
Study Overview
Status
Terminated
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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".
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Study Participants
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.
|
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.
|
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 31+/- 5 days, Day 30+6 months (approximately)
|
PHQ-9 is a self reported depression scale.
|
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
GAD-7 is a self-reported questionnaire used to assess anxiety symptoms.
|
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
|
Change in The HERO Wellness Scale
Time Frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
The HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism.
|
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
|
Change in World Health Organization-5 (WHO-5)
Time Frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
WHO-5 is a brief scale that measures mental well-bring.
|
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
|
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
Time Frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
CPFQ is a brief scale that measures cognitive and executive dysfunction.
|
Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Post-Program Participant Questionnaire
Time Frame: Day 31+/- 5 days
|
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.
|
Day 31+/- 5 days
|
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)
September 5, 2017
Primary Completion (ACTUAL)
October 10, 2017
Study Completion (ACTUAL)
October 13, 2017
Study Registration Dates
First Submitted
August 29, 2017
First Submitted That Met QC Criteria
September 1, 2017
First Posted (ACTUAL)
September 5, 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
- 365
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.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
Clinical Trials on WILD 5 Wellness Interventions
-
Beloit CollegeCompletedDepression | Anxiety | Wellness | Cognitive FunctioningUnited States
-
University of Texas at AustinCompleted
-
University of Texas at AustinCompletedHealthy | Chronic Pain | Stress, PsychologicalUnited States
-
University of Texas at AustinCompletedHealthy | Rheumatoid Arthritis | Chronic Pain | Stress | PsychologicalUnited States
-
Cardiff UniversityPodiatry Department, Cardiff & Vale University Health Board; School of Health... and other collaboratorsUnknownChronic Kidney DiseaseUnited Kingdom
-
Medical University of South CarolinaCompletedColorectal Surgery | Hepatobiliary SurgeryUnited States
-
Columbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Swiss... and other collaboratorsCompleted
-
Eduardo Vargas-BaqueroUnknown