- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03918083
WILD 5 Wellness: A 30-Day Intervention for Residents
WILD (WILD = Wellness Interventions for Life's Demands) 5 Wellness: A 30-Day Intervention for Residents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Data from the initial pilot of Wild 5 Wellness data reported at the Annual US Psychiatric Congress Meeting demonstrated positive results with their 30-day intervention: This study uses compelling proof that even a non-medication, self-directed, low cost 30-day intervention, focusing on mental wellness offers clinically significant help with mood, anxiety, mindfulness, sleep, social connectivity, and emotional eating (Jain et al., 2015)
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention amongst residents at Orange Park Medical Center (OPMC) by combining five wellness elements including: exercise, mindfulness, sleep, social connectedness, and nutrition.
Data will be collected to evaluate participants' adherence and response to 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 among residents at OPMC.
To the best of our knowledge, even though there is abundant research supporting each of the WILD 5 Wellness elements (exercise, mindfulness, sleep, social connectedness, and nutrition) individually, there is no research exploring the effectiveness of an integrated, prescriptive, and trackable wellness intervention combining these five elements. Therefore, this work will be unique in that it will collect both objective and subjective data to assess the feasibility and effectiveness of this type of wellness intervention. It will lend support to the growing body of research on the efficacy of wellness interventions for a variety of different health conditions, as well as a residency-based population. Finally, it is hoped that positive results will yield increased access to and utilization of this type of intervention, thereby improving resident wellness.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: AlexandraMary Kelada, DO, MPH
- Phone Number: 904-518-1164
- Email: alexandramary.kelada@hcahealthcare.com
Study Contact Backup
- Name: Kevin Wombacher, PhD
- Phone Number: 9046392005
- Email: kevin.wombacher@hcahealthcare.com
Study Locations
-
-
Florida
-
Orange Park, Florida, United States, 32073
- Recruiting
- Orange Park Medical Center
-
Contact:
- Kevin Wombacher, PhD
- Phone Number: 904-639-2005
- Email: kevin.wombacher@hcahealthcare.com
-
Principal Investigator:
- AlexandraMary Kelada, DO, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- participants must be enrolled residents at Orange Park Medical Center (OPMC).
Exclusion Criteria:
- Refusal to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 5-pronged wellness approach
30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition
|
Assess the feasibility of an integrated, prescriptive, and trackable wellness intervention amongst residents at Orange Park Medical Center (OPMC) by combining five wellness elements including: exercise, mindfulness, sleep, social connectedness, and nutrition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in overall combined wellness score
Time Frame: 0 and 31 days
|
Change in overall combined wellness score
|
0 and 31 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 0 and 31 days
|
A self-reported depression scale used to assess severity of depression.
|
0 and 31 days
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 0 and 31 days
|
A self-reported questionnaire used to assess anxiety symptoms.
|
0 and 31 days
|
Change in World Health Organization-5 (WHO-5)
Time Frame: 0 and 31 days
|
A brief scale that measures mental well- being.
|
0 and 31 days
|
Change in The Sleep Condition Indicator (SCI)
Time Frame: 0 and 31 days
|
A brief scale that evaluates insomnia disorder.
|
0 and 31 days
|
Change in The Social Connectedness Scale (SCS)
Time Frame: 0 and 31 days
|
A brief scale that assesses the degree to which respondents feel connected to others.
|
0 and 31 days
|
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
Time Frame: 0 and 31 days
|
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
|
0 and 31 days
|
Change in The WILD 5 Wellness Scale (W5WS)
Time Frame: 0 and 31 days
|
A brief scale designed specifically for this project to measure wellness.
|
0 and 31 days
|
The Post-Program Participant Questionnaire
Time Frame: 31 days
|
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
|
31 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AlexandraMary Kelada, DO, MPH, Orange Park Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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