| 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 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 63 participants |
| Allocation: | N/A |
| 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.
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Contact: AlexandraMary Kelada, DO, MPH | 904-518-1164 | alexandramary.kelada@hcahealthcare.com | |
| Contact: Kevin Wombacher, PhD | 9046392005 | kevin.wombacher@hcahealthcare.com |
| 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 | |
| Principal Investigator: | AlexandraMary Kelada, DO, MPH | Orange Park Medical Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 15, 2019 | ||||||||
| First Posted Date ICMJE | April 17, 2019 | ||||||||
| Last Update Posted Date | April 17, 2019 | ||||||||
| Actual Study Start Date ICMJE | April 10, 2019 | ||||||||
| Estimated Primary Completion Date | April 10, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in overall combined wellness score [ Time Frame: 0 and 31 days ] Change in overall combined wellness score
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | WILD 5 Wellness: A 30-Day Intervention for Residents | ||||||||
| Official Title ICMJE | WILD (WILD = Wellness Interventions for Life's Demands) 5 Wellness: A 30-Day Intervention for Residents | ||||||||
| 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. | ||||||||
| 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A 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 |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | 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.
|
||||||||
| Study Arms ICMJE | 5-pronged wellness approach
30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition
Intervention: Behavioral: Wellness
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
63 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 10, 2022 | ||||||||
| Estimated Primary Completion Date | April 10, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03918083 | ||||||||
| Other Study ID Numbers ICMJE | 2019-014 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | AlexandraMary Kelada, DO, MPH, Orange Park Medical Center | ||||||||
| Study Sponsor ICMJE | Orange Park Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | Orange Park Medical Center | ||||||||
| Verification Date | April 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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