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WILD 5 Wellness: A 30-Day Intervention for Residents

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ClinicalTrials.gov Identifier: NCT03918083
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
AlexandraMary Kelada, DO, MPH, Orange Park Medical Center

Brief Summary:
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention amongst resident physicians combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

Condition or disease Intervention/treatment Phase
Resident Wellness Burnout, Professional Medical Residents Mental Health Wellness 1 Mental Health Disorder Resident Physician Behavioral: Wellness Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Intervention Model: Single Group Assignment
Intervention Model Description: WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WILD (WILD = Wellness Interventions for Life's Demands) 5 Wellness: A 30-Day Intervention for Residents
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : April 10, 2022
Estimated Study Completion Date : April 10, 2022

Arm Intervention/treatment
5-pronged wellness approach
30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition
Behavioral: Wellness
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.




Primary Outcome Measures :
  1. Change in overall combined wellness score [ Time Frame: 0 and 31 days ]
    Change in overall combined wellness score


Secondary Outcome Measures :
  1. 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.

  2. Change in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 0 and 31 days ]
    A self-reported questionnaire used to assess anxiety symptoms.

  3. Change in World Health Organization-5 (WHO-5) [ Time Frame: 0 and 31 days ]
    A brief scale that measures mental well- being.

  4. Change in The Sleep Condition Indicator (SCI) [ Time Frame: 0 and 31 days ]
    A brief scale that evaluates insomnia disorder.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • participants must be enrolled residents at Orange Park Medical Center (OPMC).

Exclusion Criteria:

  • Refusal to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918083


Contacts
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Contact: AlexandraMary Kelada, DO, MPH 904-518-1164 alexandramary.kelada@hcahealthcare.com
Contact: Kevin Wombacher, PhD 9046392005 kevin.wombacher@hcahealthcare.com

Locations
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United States, Florida
Orange Park Medical Center Recruiting
Orange Park, Florida, United States, 32073
Contact: Kevin Wombacher, PhD    904-639-2005    kevin.wombacher@hcahealthcare.com   
Principal Investigator: AlexandraMary Kelada, DO, MPH         
Sponsors and Collaborators
Orange Park Medical Center
Investigators
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Principal Investigator: AlexandraMary Kelada, DO, MPH Orange Park Medical Center

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Responsible Party: AlexandraMary Kelada, DO, MPH, Internal medicine resident, Orange Park Medical Center
ClinicalTrials.gov Identifier: NCT03918083     History of Changes
Other Study ID Numbers: 2019-014
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared.

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

Additional relevant MeSH terms:
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Burnout, Professional
Mental Disorders
Occupational Stress
Occupational Diseases
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms