Resident WellnessNCT03918083
WILD 5 Wellness: A 30-Day Intervention for Residents
A study testing Wellness in people with Resident Wellness and Burnout, Professional, run by Orange Park Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resident Wellness, Burnout, Professional, Medical Residents
- What is being tested?
- Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 10 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants must be enrolled residents at Orange Park Medical Center (OPMC).
Who cannot join
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Orange Park Medical Center
Orange Park, Florida, 32073
Kevin Wombacher, PhD, 904-639-2005, kevin.wombacher@hcahealthcare.com
AlexandraMary Kelada, DO, MPH
About this study
Official title: WILD (WILD = Wellness Interventions for Life's Demands) 5 Wellness: A 30-Day Intervention for Residents
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.
Read the 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.
- Conditions
- Resident Wellness, Burnout, Professional, Medical Residents, Mental Health Wellness 1, Mental Health Disorder, Resident Physician
- Being tested
- Wellness
- Medical subject headings
- Burnout, Professional, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellnessBehavioural
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 group | Role | What they receive |
|---|---|---|
| 5-pronged wellness approach | Other | 30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition Receives: Behavioral: Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall combined wellness score
Change in overall combined wellness score
Measured: 0 and 31 days
Secondary outcomes (8)
Change in Patient Health Questionnaire-9 (PHQ-9)
A self-reported depression scale used to assess severity of depression.
Measured: 0 and 31 days
Change in Generalized Anxiety Disorder-7 (GAD-7)
A self-reported questionnaire used to assess anxiety symptoms.
Measured: 0 and 31 days
Change in World Health Organization-5 (WHO-5)
A brief scale that measures mental well- being.
Measured: 0 and 31 days
Change in The Sleep Condition Indicator (SCI)
A brief scale that evaluates insomnia disorder.
Measured: 0 and 31 days
Change in The Social Connectedness Scale (SCS)
A brief scale that assesses the degree to which respondents feel connected to others.
Measured: 0 and 31 days
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
Measured: 0 and 31 days
Change in The WILD 5 Wellness Scale (W5WS)
A brief scale designed specifically for this project to measure wellness.
Measured: 0 and 31 days
The Post-Program Participant Questionnaire
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start10 Apr 2019
- Primary completion10 Apr 2022 (estimated)
- Study completion10 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resident WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orange Park Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlexandraMary Kelada, DO, MPH, Orange Park Medical Center
- Investigators
- AlexandraMary Kelada, DO, MPH, Principal investigator, Orange Park Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918083
- Sponsor's protocol ID
- 2019-014
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WILD (WILD = Wellness Interventions for Life's Demands) 5 Wellness: A 30-Day Intervention for Residents
- ClinicalTrials.gov ID
- NCT03918083
- Acronym / sponsor ID
- 2019-014
- Conditions
- Resident Wellness, Burnout, Professional, Medical Residents, Mental Health Wellness 1, Mental Health Disorder, Resident Physician
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Orange Park Medical CenterUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 10 Apr 2022 (estimated)
- Study completion
- 10 Apr 2022 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5-pronged wellness approach | Other | Behavioral: Wellness30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants must be enrolled residents at Orange Park Medical Center (OPMC).
Key exclusion criteria (1 listed)
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WellnessAssess 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. | Behavioural | 5-pronged wellness approach |
Primary outcome
Change in overall combined wellness score
Time frame: 0 and 31 days
Change in overall combined wellness score
8 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: 0 and 31 days
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 0 and 31 days
Change in World Health Organization-5 (WHO-5)
Time frame: 0 and 31 days
Change in The Sleep Condition Indicator (SCI)
Time frame: 0 and 31 days
Change in The Social Connectedness Scale (SCS)
Time frame: 0 and 31 days
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
Time frame: 0 and 31 days
Change in The WILD 5 Wellness Scale (W5WS)
Time frame: 0 and 31 days
The Post-Program Participant Questionnaire
Time frame: 31 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AlexandraMary Kelada, DO, MPH principal investigator
Orange Park Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness in people with Resident Wellness and Burnout, Professional, run by Orange Park Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AlexandraMary Kelada, DO, MPH (904-518-1164, alexandramary.kelada@hcahealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall combined wellness score (time frame: 0 and 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.