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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03918083
Other study ID # 2019-014
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2019
Est. completion date April 10, 2022

Study information

Verified date April 2019
Source Orange Park Medical Center
Contact AlexandraMary Kelada, DO, MPH
Phone 904-518-1164
Email alexandramary.kelada@hcahealthcare.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 63
Est. completion date April 10, 2022
Est. primary completion date April 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Refusal to participate.

Study Design


Intervention

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.

Locations

Country Name City State
United States Orange Park Medical Center Orange Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Orange Park Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in overall combined wellness score Change in overall combined wellness score 0 and 31 days
Secondary Change in Patient Health Questionnaire-9 (PHQ-9) A self-reported depression scale used to assess severity of depression. 0 and 31 days
Secondary Change in Generalized Anxiety Disorder-7 (GAD-7) A self-reported questionnaire used to assess anxiety symptoms. 0 and 31 days
Secondary Change in World Health Organization-5 (WHO-5) A brief scale that measures mental well- being. 0 and 31 days
Secondary Change in The Sleep Condition Indicator (SCI) A brief scale that evaluates insomnia disorder. 0 and 31 days
Secondary Change in The Social Connectedness Scale (SCS) A brief scale that assesses the degree to which respondents feel connected to others. 0 and 31 days
Secondary 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. 0 and 31 days
Secondary Change in The WILD 5 Wellness Scale (W5WS) A brief scale designed specifically for this project to measure wellness. 0 and 31 days
Secondary 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. 31 days
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