WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Wellness Element 1 - Exercise
- Behavioral: Wellness Element 2 - Mindfulness
- Behavioral: Wellness Element 3 - Sleep Hygiene
- Behavioral: Wellness Element 4 - Social Connectedness
- Behavioral: Wellness Element 5 - Nutrition
- Behavioral: Wellness Element 6 - Wellness Exercises
- Behavioral: Wellness Element 7 - Motivational Messages
Detailed Description
This study involves participating in a 90-day integrated, prescriptive, trackable wellness intervention, which includes five wellness elements: exercise, mindfulness, sleep, social connectedness, and nutrition.
The intervention is divided into three phases (each spanning 30-days): Phase 1 - 'Boot Camp', Phase 2 - Solidify, and Phase 3 - Sustain. Program requirements include: Implementing 5 wellness interventions daily for the first 30-days, at least 5 days for the next 30-days, and at least 3 days for the final 30-days, documenting daily online adherence, completing daily wellness exercises to improve mental wellness, and completing online program forms prior to beginning the program, at 30-days, and again at 90-days.
Once eligibility is confirmed via the initial orientation/screening call, study personnel will mail each participant a WILD 5 Wellness Workbook within one day of emailing participants their unique identification codes plus their start dates. Participants will be instructed to document adherence regarding their daily wellness practices and their daily wellness exercises online via Qualtrics, an online survey software. Participants can document their daily adherence using their computer and/or their smartphone as Qualtrics offers a mobile version of the Participant Tracking Form. A copy of the Participant Tracking Form will also be available in the WILD 5 Workbook so participants that prefer keeping a daily paper log can do so, and they can then transfer their program adherence information to the online Participant Tracking Form throughout the program. The workbook will contain the participant's personal identification code; no personal identification will appear in the workbook in order to protect participant confidentiality.
One day prior to a participant's start date, which will be set during the orientation/screening call, participants will receive an automated email from an online automated email service (MailChimp), with a reminder about their start date, and encouragement to contact study personnel with any questions or concerns.
Participants will also receive daily motivational emails from an online automated email service (MailChimp), which will provide general information about one of the five wellness elements and/or one of the wellness exercises, as well as encouragement to track their participation on a daily basis, and encouragement to contact study personnel via email with any questions and/or concerns.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78701
- University of Texas at Austin School of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults (18 years of age or older)
- English- speaking
- Access to a reliable Internet-enabled computer
- Possess basic computer skills
- Self-identify as having at least one of the health conditions listed on the online registration form or
- Self-identify as a community participant without a health condition.
Exclusion Criteria:
- Acutely suicidal and/or actively psychotic
- Non-English speaking
- Do not have access to an Internet-enabled computer
- Report a lack of basic computer skills
- Pregnant or plan to get pregnant during the next 90-days.
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 |
|---|---|
|
Experimental: Wellness Intervention
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
|
1. Daily wellness element focusing on Exercise; adherence documented online daily
2. Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
3. Daily wellness element focusing on sleep hygiene; adherence documented online daily
4. Daily wellness element focusing on Social Connectedness; adherence documented online daily
5. Daily wellness element focusing on Nutrition; adherence documented online daily
6. Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily
7. Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A self-reported depression scale used to assess severity of depression.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A self-reported questionnaire used to assess anxiety symptoms.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in World Health Organization-5 (WHO-5)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A brief scale that measures mental well- being.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The Mindful Attention Awareness Scale (MAAS)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A popular measure of mindfulness.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The Sleep Condition Indicator (SCI)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A brief scale that evaluates insomnia disorder.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The Social Connectedness Scale (SCS)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A brief scale that assesses the degree to which respondents feel connected to others.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)
Time Frame: 0, 30, and 90 - Primary endpoint is 30 days
|
A combination of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets shown to lower a person's risk of developing Alzheimer's disease.
|
0, 30, and 90 - Primary endpoint is 30 days
|
|
Change in The Brief Pain Inventory (BPI)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A measurement tool for assessing clinical pain.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The Sheehan Disability Scale (SDS)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A measurement tool for assessing functional impairment in three inter-related domains: work/school, social and family life.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The Endicott Work Productivity Scale (EWPS)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A brief self-report questionnaire designed to obtain a sensitive measure of work productivity.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A brief scale that measures cognitive and executive dysfunction.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The WILD 5 Wellness Scale (W5WS)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A brief scale designed specifically for this project to measure wellness.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The WILD 5 Wellness Effort Scale (W5ES)
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A scale designed specifically for this project to measure weekly adherence with program elements.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
Change in The WILD 5 Wellness Elements Scale
Time Frame: 0, 30, and 90 days - Primary endpoint is 30 days
|
A scale designed specifically for this project to measure elements of depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional eating, diet practices, pain, disability, work productivity, happiness, enthusiasm, resilience, and optimism.
|
0, 30, and 90 days - Primary endpoint is 30 days
|
|
The Post-Program Participant Questionnaire
Time Frame: 90 days
|
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saundra M Jain, PsyD, LPC, University of Texas at Austin
Publications and helpful links
General Publications
- Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.
- Cruwys T, Dingle GA, Haslam C, Haslam SA, Jetten J, Morton TA. Social group memberships protect against future depression, alleviate depression symptoms and prevent depression relapse. Soc Sci Med. 2013 Dec;98:179-86. doi: 10.1016/j.socscimed.2013.09.013. Epub 2013 Sep 25.
- Fardet A, Boirie Y. Associations between food and beverage groups and major diet-related chronic diseases: an exhaustive review of pooled/meta-analyses and systematic reviews. Nutr Rev. 2014 Dec;72(12):741-62. doi: 10.1111/nure.12153. Epub 2014 Nov 18.
- Hui SK, Grandner MA. Associations between Poor Sleep Quality and Stages of Change of Multiple Health Behaviors among Participants of Employee Wellness Program. Prev Med Rep. 2015 Jan 1;2:292-299. doi: 10.1016/j.pmedr.2015.04.002.
- Jeste DV, Palmer BW, Rettew DC, Boardman S. Positive psychiatry: its time has come. J Clin Psychiatry. 2015 Jun;76(6):675-83. doi: 10.4088/JCP.14nr09599.
- Williams JM, Crane C, Barnhofer T, Brennan K, Duggan DS, Fennell MJ, Hackmann A, Krusche A, Muse K, Von Rohr IR, Shah D, Crane RS, Eames C, Jones M, Radford S, Silverton S, Sun Y, Weatherley-Jones E, Whitaker CJ, Russell D, Russell IT. Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. J Consult Clin Psychol. 2014 Apr;82(2):275-86. doi: 10.1037/a0035036. Epub 2013 Dec 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-07-0021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.