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Completed

NCT Number: NCT02918513

WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)

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

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Key information

Conditions

Chronic Pain Behavior Behavioral Symptoms Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin School of Nursing

Austin, Texas, 78701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wellness Element 1 - Exercise

Behavioral
  • Daily wellness element focusing on Exercise; adherence documented online daily

Wellness Element 2 - Mindfulness

Behavioral
  • Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily

Wellness Element 3 - Sleep Hygiene

Behavioral
  • Daily wellness element focusing on sleep hygiene; adherence documented online daily

Wellness Element 4 - Social Connectedness

Behavioral
  • Daily wellness element focusing on Social Connectedness; adherence documented online daily

Wellness Element 5 - Nutrition

Behavioral
  • Daily wellness element focusing on Nutrition; adherence documented online daily

Wellness Element 6 - Wellness Exercises

Behavioral
  • Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily

Wellness Element 7 - Motivational Messages

Behavioral
  • Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2016
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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